WO2023133724A1 - 可在超声显影引导下植入的介入瓣膜 - Google Patents

可在超声显影引导下植入的介入瓣膜 Download PDF

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WO2023133724A1
WO2023133724A1 PCT/CN2022/071572 CN2022071572W WO2023133724A1 WO 2023133724 A1 WO2023133724 A1 WO 2023133724A1 CN 2022071572 W CN2022071572 W CN 2022071572W WO 2023133724 A1 WO2023133724 A1 WO 2023133724A1
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valve
interventional
area
developing area
guidance
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PCT/CN2022/071572
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English (en)
French (fr)
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钟生平
徐中
靳永富
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金仕生物科技（常熟）有限公司
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Priority to PCT/CN2022/071572 priority Critical patent/WO2023133724A1/zh
Publication of WO2023133724A1 publication Critical patent/WO2023133724A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F2/00—Filters 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart 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, in particular to an interventional valve that can be implanted under the guidance of ultrasound imaging.
  • the interventional valve During the implantation process of the interventional valve, it needs to be guided by images to complete the implantation operation.
  • the structural state of the implanted site can be seen through imaging equipment, and the structural image of the implanted valve can also be seen at the same time.
  • the traditional implantation process it is generally carried out under the guidance of a combination of contrast and ultrasound.
  • the internal contours of the organs can only be displayed at the moment of injection of the contrast agent, and the image will disappear after a few seconds.
  • the operator can only rely on the memory of the imaging image. Operation, which greatly reduces the accuracy of the operation and increases the risk of surgery.
  • some surgeons draw the outline of the image on the monitor with a marker pen to guide the subsequent implantation operation.
  • the organ is a non-stop moving tissue and organ, the marks on the monitor are not The real organ position, therefore, operations that rely on such images can also introduce errors in implantation and pose risks to surgery.
  • the ultrasonic method can see the muscular tissue of the organ, and can also display images in real time, because most of the instruments have smooth surfaces, the ultrasonic images are blurry, and it is difficult to perform implantation operations through ultrasonic images without special treatment of the instruments. .
  • the purpose of this application is to provide an interventional valve that can be implanted under the guidance of ultrasound imaging, so as to solve the above-mentioned problem in the prior art that it is difficult to perform interventional valve implantation by influencing the device.
  • the present application provides an interventional valve that can be implanted under the guidance of ultrasound imaging, which includes a valve frame and a valve skirt, and the valve skirt is fixedly covered on the inner wall of the valve frame;
  • valve frame and/or the valve skirt are provided with a development area, and the material roughness of the development area is greater than the material roughness of the area outside the development area; and/or, the development area is provided with Particles of a material different from the material of the developer zone.
  • the material of the particle is different from the material of the valve frame or the valve skirt under ultrasonic imaging; the material of the particle is a metal material, a polymer material, glass, ceramics one or more of.
  • the particles are in the shape of a sphere, an ellipsoid, a column or a polyhedron.
  • the particle is a sphere, and the diameter of the particle is 50-80 ⁇ m.
  • the particles are adhered to the surface of the developing area.
  • the developing area is dot-shaped, linear-shaped or planar-shaped.
  • the interventional valve is an interventional mitral valve
  • the interventional mitral valve includes a long axis and a short axis, and when the valve frame is stretched, one end of the valve frame is formed with An eversion structure
  • the developing area includes a first developing area and a second developing area
  • both ends of the everted structure are provided with the first developing area, and the first developing area is linear;
  • the two ends of the everted structure are provided with the second developing area, and the second developing area is dot-shaped.
  • a carrier is further included, the particles are fixed on the carrier, and the carrier is fixed on the developing area.
  • the shape of the carrier is point, line or plane.
  • the surface of the developing area is formed with ridges, bumps, pits or grooves.
  • the interventional valve provided by this application that can be implanted under the guidance of ultrasound imaging, by increasing the roughness of the imaging area or setting particles, can make the ultrasound image of the imaging area clearly visible in real time, which is convenient for the operator to understand the implantation status of the interventional valve. fast and accurate adjustment.
  • Figure 1 is a schematic structural diagram of an interventional valve that can be implanted under the guidance of ultrasound imaging provided by the embodiment of the present application;
  • Fig. 2 is a side view of Fig. 1 in one direction;
  • Fig. 3 is a side view of Fig. 1 in another direction;
  • Fig. 4 is a state diagram of an implanted interventional valve that can be implanted under the guidance of ultrasound imaging according to the embodiment of the present application after implantation.
  • connection can be a fixed connection, a detachable connection, or an integrated Connected, or electrically connected; either directly or indirectly through an intermediary.
  • the embodiment of the present application provides an interventional valve implantable under the guidance of ultrasound imaging (hereinafter referred to as the interventional valve 1), which includes a valve frame 100 and a valve skirt, and the valve skirt is fixedly covered on the The inner wall of the petal frame 100; wherein, the petal frame 100 and/or the petal skirt are provided with a development area 200, and the material roughness of the development area 200 is greater than the material roughness of the area outside the development area 200; and/or, the development area 200 is provided with As for the particles, the material of the particles is different from the material of the developing area 200 .
  • the interventional valve 1 which includes a valve frame 100 and a valve skirt, and the valve skirt is fixedly covered on the The inner wall of the petal frame 100; wherein, the petal frame 100 and/or the petal skirt are provided with a development area 200, and the material roughness of the development area 200 is greater than the material roughness of the area outside the development area 200; and/or, the development area 200 is provided with As for the particles
  • the roughness of the material of the developing area 200 is relatively large, so that the ultrasonic image at the position of the developing area 200 can be relatively clear, so that the clear distinction of the developing area 200 can be realized.
  • the developing area 200 can be formed not only on the valve frame 100, but also on the valve skirt.
  • the surface at the developing area 200 on the petal frame 100 or the petal skirt can be processed to make the surface material of the developing area 200 more rough, such as changing the degree of friction on the developing area 200 surface, increasing the surface of the material in the developing area 200, etc. , so that the image of the developing area 200 developed by ultrasound can be clearer.
  • particles can also be embedded in the developing area 200 , and the material of the particles can be different from that of the developing area 200 , so that the developing area 200 can be clearly distinguished from other parts in the ultrasonic image.
  • changing the roughness of the developing area 200 and setting particles in the developing area 200 can be used in combination.
  • the developing area 200 is arranged on the petal frame 100, the roughness of the material located in the developing area 200 on the petal frame 100 can be changed.
  • the material of the petal frame 100 is generally metal, and the method of changing the roughness of the metal surface can be used to facilitate the installation of the petal frame.
  • the development area 200 is formed on the 100, and the process is simple if the roughness is increased by grinding process. If the developing area 200 is set on the valve skirt, particles can be fixed on the valve skirt, which is beneficial to form the developing area 200 on the valve skirt.
  • convex ribs, bumps, pits or grooves may also be formed on the surface of the developing area 200 through processing technology, so as to make the surface of the developing area 200 uneven and improve the imaging effect.
  • the material of the microparticles and the material of the valve frame or skirt have different contrasts under ultrasonic imaging; the material of the microparticles can be one or more of metal materials, polymer materials, glass, and ceramics.
  • the material of the particles can be a non-metallic polymer material, such as plastic, so that the image effect under ultrasonic development can be clearly distinguished, thereby The microparticles passing through the developing area 200 can be used as position markers to facilitate the implantation operation of the interventional valve 1 .
  • the developing area 200 is formed on the petal skirt, since the material of the petal skirt is generally cloth, the material of the particles is made of metal, and the developing area 200 provided with the particles can also be clearly distinguished from other areas, so that through the development
  • the microparticles at the zone 200 serve as position markers, facilitating the implantation procedure of the interventional valve 1 .
  • the shape of the particles can be spherical, ellipsoidal, cylindrical or polyhedral.
  • the shape of the particles can be spherical, such as metal beads, plastic beads, etc.
  • the diameter of the microparticles may be 50-80 ⁇ m. Particles in this size range can ensure clear imaging while avoiding excessive particle size resulting in excessive weight, ensuring the lightweight of the interventional valve 1, and particles in this size range can be evenly distributed in the development area 200, making the development
  • the region 200 can clearly appear in the shape of points, lines or planes in the ultrasound image, which is convenient for the operator to determine the position.
  • the particles can be glued to the surface of the developing area 200, so as to facilitate the fixing of the particles.
  • some parts of the particles can protrude from the surface of the developing area 200 , so that the surface of the developing area 200 can be formed in an uneven shape, making the ultrasonic image clearer.
  • the developing area 200 is dot-shaped, linear-shaped or planar-shaped.
  • the interventional valve 1 can be provided with different shapes of developing areas 200 at different positions, so that the operator can distinguish different positions of the interventional valve 1 .
  • the interventional valve 1 provided in the embodiment of the present application is an interventional mitral valve
  • the interventional mitral valve includes a long axis and a short axis
  • the valve frame 100 is in a stretched state, and one end of the valve frame 100 is formed with an everted structure 110
  • the development area 200 includes a first development area 210 and a second development area 220
  • the two ends of the eversion structure 110 are provided with a first development area 210
  • the first development area 210 is a line shape
  • the two ends of the eversion structure 110 are provided with a second developing area 220
  • the second developing area 220 is dot-shaped.
  • the valgus structure 110 can be fitted with the human mitral valve ring, which is a D-shaped structure or an elliptical structure with a high front and a low back, and left and right symmetry.
  • the angle of the interventional mitral valve needs to be adjusted so that the interventional mitral valve can match the shape of the human mitral valve annulus.
  • Valve annulus anastomosis by setting the dot-shaped second development area 220 on the eversion structure 110, the positions of the two ends of the eversion structure 110 in the short-axis direction can be determined according to the dot-like development in the ultrasound image.
  • the axial direction is a symmetrical structure, and when the positions of the second imaging areas 220 at both ends of the intervening mitral valve coincide, it can be determined that the implantation position and posture of the intervening mitral valve are accurate.
  • the operator can quickly and accurately adjust the implantation state of the intervening mitral valve, realizing the precise implantation of the intervening valve 1 .
  • the interventional valve 1 further includes a carrier, particles can be fixed on the carrier, and the carrier is fixed on the developing area 200 .
  • the material of the carrier can be cloth, the particles can be fixedly embedded on the carrier, and the carrier embedded with the particles can be fixed in the developing area 200 as a whole, so that the particles can be conveniently placed on the valve frame 100 or the valve skirt.
  • the carrier in order to facilitate the fixation of the carrier, the carrier is preferably fixed on the valve skirt, the material of the carrier can be the same as that of the valve skirt, and the material of the particles is different from that of the carrier, so as to avoid the interference of the carrier on the particles in the ultrasound image .
  • the shape of the carrier can be point, line or plane.
  • the microparticles can be evenly distributed on the carrier, so that the imaging of the microparticles in the ultrasonic image can form a shape similar to the shape of the carrier, which is convenient for the operator to identify and distinguish.

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  • Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
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Abstract

一种可在超声显影引导下植入的介入瓣膜（1），其包括瓣架（100）和瓣裙，瓣裙固定覆盖于瓣架（100）内壁；其中，瓣架（100）和/或瓣裙上设置有显影区（200），显影区（200）的材料粗糙度大于位于显影区（200）以外区域的材料粗糙度；和/或，显影区（200）设置有微粒，微粒的材料不同于显影区（200）的材料。通过增大显影区（200）的粗糙度或者设置微粒，可以使显影区（200）的超声图像能够实时清楚显现，方便了术者对介入瓣膜（1）植入状态的快速准确调整。

Description

可在超声显影引导下植入的介入瓣膜 技术领域
本申请涉及医疗器械技术领域，尤其涉及一种可在超声显影引导下植入的介入瓣膜。
背景技术
介入瓣膜在植入过程中需要借助影像的引导下来完成植入操作。通过影像设备可以看到植入部位的结构状态，同时也可以看到植入瓣膜的结构影像。传统的植入过程中，一般通过造影和超声联合方式的引导下进行。
由于造影方式无法见到肌肉组织，只有在注入造影剂的瞬间才能显现脏器的内部轮廓，几秒钟后这个影像就消失，植入过程中术者只能凭对造影时影像的记忆来进行操作，这大大降低了操作的准确性，增加了手术的风险。另外，也有术者将影像的轮廓在显示器上用记号笔勾画下来，用以指导后面的植入操作，但是，由于脏器是一个不停运动的组织器官，因此，在显示器上的标记并不是真实的器官位置，因此，依靠这种影像进行的操作也会给植入造成误差，为手术带来风险。
超声方式虽然可以见到器官的肌肉组织，也可以实时显示图像，但由于器械多为光滑表面，超声图像较模糊，在对器械不做专门处理的情况下，很难通过超声图像进行植入操作。
申请内容
本申请的目的是提供一种可在超声显影引导下植入的介入瓣膜，以解决上述现有技术中难以通过影响设备进行介入瓣膜植入操作的问题。
本申请供了一种可在超声显影引导下植入的介入瓣膜，其中，包括瓣架和瓣裙，所述瓣裙固定覆盖于所述瓣架内壁；
其中，所述瓣架和/或所述瓣裙上设置有显影区，所述显影区的材料粗糙度大于位于所述显影区以外区域的材料粗糙度；和/或，所述显影区设置有微粒，所述微粒的材料不同于所述显影区的材料。
在一种可能的实现方式中，所述微粒的材料与所述瓣架或所述瓣裙的材料在超声显影下的对比度不同；所述微粒的材料为金属材料、高分子材料、玻璃、陶瓷中的一种或多种。
在一种可能的实现方式中，所述微粒为球体、椭球体、柱状体或多面体形状。
在一种可能的实现方式中，所述微粒为球体，所述微粒的直径为50～80μm。
在一种可能的实现方式中，所述微粒粘接于所述显影区的表面。
在一种可能的实现方式中，所述显影区为点状、线状或面状。
在一种可能的实现方式中，所述介入瓣膜为介入二尖瓣，所述介入二尖瓣包括长 轴和短轴，所述瓣架在撑开状态下，所述瓣架的一端形成有外翻结构；所述显影区包括第一显影区和第二显影区；
沿所述介入二尖瓣的长轴方向，所述外翻结构的两端设置有所述第一显影区，所述第一显影区为线状；
沿所述介入二尖瓣的短轴方向，所述外翻结构的两端设置有所述第二显影区，所述第二显影区为点状。
在一种可能的实现方式中，还包括载体，所述微粒固定于所述载体，所述载体固定于所述显影区。
在一种可能的实现方式中，所述载体的形状为点状、线状或面状。
在一种可能的实现方式中，所述显影区的表面形成有凸棱、凸点、凹坑或凹槽。
本申请提供的技术方案可以达到以下有益效果：
本申请提供的可在超声显影引导下植入的介入瓣膜，通过增大显影区的粗糙度或者设置微粒，可以使显影区的超声图像能够实时清楚显现，方便了术者对介入瓣膜植入状态的快速准确调整。
应当理解的是，以上的一般描述和后文的细节描述仅是示例性的，并不能限制本申请。
附图说明
图1为本申请实施例提供的可在超声显影引导下植入的介入瓣膜的结构示意图；
图2为图1在一个方向的侧视图；
图3为图1在另一个方向的侧视图；
图4为本申请实施例提供的可在超声显影引导下植入的介入瓣膜在植入后的状态图。
附图标记：
1-介入瓣膜；
100-瓣架；
110-外翻结构；
200-显影区；
210-第一显影区；
220-第二显影区。
此处的附图被并入说明书中并构成本说明书的一部分，示出了符合本申请的实施例，并与说明书一起用于解释本申请的原理。
具体实施方式
为了使本申请的目的、技术方案及优点更加清楚明白，以下结合附图及实施例，对本申请进行进一步详细说明。应当理解，此处所描述的具体实施例仅仅用以解释本申请，并不用于限定本申请。
在本申请的描述中，除非另有明确的规定和限定，术语“第一”、“第二”仅用于描述的目的，而不能理解为指示或暗示相对重要性；除非另有规定或说明，术语“多 个”是指两个或两个以上；术语“连接”、“固定”等均应做广义理解，例如，“连接”可以是固定连接，也可以是可拆卸连接，或一体地连接，或电连接；可以是直接相连，也可以通过中间媒介间接相连。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。
本说明书的描述中，需要理解的是，本申请实施例所描述的“上”、“下”等方位词是以附图所示的角度来进行描述的，不应理解为对本申请实施例的限定。此外，在上下文中，还需要理解的是，当提到一个元件连接在另一个元件“上”或者“下”时，其不仅能够直接连接在另一个元件“上”或者“下”，也可以通过中间元件间接连接在另一个元件“上”或者“下”。
如图1至图4所示，本申请实施例提供了一种可在超声显影引导下植入的介入瓣膜(下文简称介入瓣膜1)，其包括瓣架100和瓣裙，瓣裙固定覆盖于瓣架100内壁；其中，瓣架100和/或瓣裙上设置有显影区200，显影区200的材料粗糙度大于位于显影区200以外区域的材料粗糙度；和/或，显影区200设置有微粒，微粒的材料不同于显影区200的材料。
其中，显影区200材料的粗糙度相对较大，从而可以使显影区200位置处的超声图像相对清晰，从而可以实现对显影区200的清楚区分，在植入介入瓣膜1时，显影区200的图像可以实时清楚显现，方便了术者对介入瓣膜1植入状态的快速准确调整。
具体地，显影区200既可以形成于瓣架100，也可以形成于瓣裙。瓣架100或瓣裙上位于显影区200处的表面可以经过处理，使显影区200表面材料的粗糙度更大，如改变显影区200表面的摩擦程度，使显影区200的材料表面增加纹路等，从而可以使显影区200在超声显影的图像更清晰。或者，也可以在显影区200嵌入微粒，该微粒的材料可以与显影区200的材料不同，以使超声图像中的显影区200能够清楚地区别于其它部位。当然，改变显影区200的粗糙度和在显影区200设置微粒可以结合使用。
其中，如果显影区200设置于瓣架100，则可以改变瓣架100上位于显影区200料的粗糙度，瓣架100的材料一般为金属，采用改变金属表面粗糙度的方式可以便于在瓣架100上形成显影区200，如采用研磨工艺增加粗糙度，工艺简单。如果显影区200设置于瓣裙，则可以采用设置微粒的方式，将微粒固定于瓣裙，采用设置微粒的方式有利于在瓣裙上形成显影区200。
具体地，也可以通过加工工艺在显影区200的表面形成有凸棱、凸点、凹坑或凹槽，使显影区200的表面不平整，提升成像的效果。
作为一种具体的实现方式，微粒的材料与瓣架或瓣裙的材料在超声显影下的对比度不同；微粒的材料可以为金属材料、高分子材料、玻璃、陶瓷中的一种或多种。当显影区200形成于瓣架100时，由于瓣架100一般为金属材质，可以使微粒的材料为非金属的高分子材料，如塑料，从而可以在超声显影下的图像效果形成明显区分，从而可以使通过显影区200处的微粒提供位置标记的作用，便于介入瓣膜1的植入操作。而当显影区200形成于瓣裙时，由于瓣裙的材料一般为布，使微粒的材料为金属材质，也可以使设置有微粒的显影区200与其它区域形成明显区分，从而可以使通过显影区200处的微粒提供位置标记的作用，便于介入瓣膜1的植入操作。
其中，微粒的形状可以为球体、椭球体、柱状体或多面体形状。本申请中，微粒 的形状可以为球体，如金属珠、塑料珠等。
具体地，微粒的直径可以为50～80μm。该尺寸范围内的微粒在保证能够清晰成像的同时又可以避免微粒尺寸过大而导致重量过大，保证介入瓣膜1的轻量化，且该尺寸范围的微粒能够均匀分布于显影区200，使显影区200能够在超声图像中能够清晰呈现出点状、线状或面状，便于术者确定位置。
作为一种具体的实现方式，微粒可以胶粘于显影区200的表面，从而可以便于微粒的固定。
此外，微粒的部分部位可以凸出于显影区200的表面，从而可以使显影区200的表面形成凹凸不平的形态，使超声图片更清晰。
作为一种具体的实现方式，显影区200为点状、线状或面状。介入瓣膜1可以在不同部位设置不同形状的显影区200，以便于术者区分介入瓣膜1的不同位置。
具体地，当本申请实施例提供的介入瓣膜1为介入二尖瓣时，介入二尖瓣包括长轴和短轴，瓣架100在撑开状态下，瓣架100的一端形成有外翻结构110；显影区200包括第一显影区210和第二显影区220；沿介入二尖瓣的长轴方向，外翻结构110的两端设置有第一显影区210，第一显影区210为线状；沿介入二尖瓣的短轴方向，外翻结构110的两端设置有第二显影区220，第二显影区220为点状。
其中，在介入二尖瓣植入后，该外翻结构110可以与人体二尖瓣瓣环贴合，人体二尖瓣瓣环是一个前高后低，左右对称的D形结构或椭圆形结构，在植入介入二尖瓣时，需要调整介入二尖瓣的角度，使介入二尖瓣能够匹配人体二尖瓣瓣环的形状。通过在外翻结构110上设置线状的第一显影区210，可以在超声图像中根据线状显影确定外翻结构110在长轴方向上两端的位置，以保证外翻结构110能够与人体二尖瓣瓣环吻合；通过在外翻结构110上设置点状的第二显影区220，可以超声图像中根据点状显影确定外翻结构110在短轴方向上两端的位置，由于介入二尖瓣在短轴方向为对称结构，当介入二尖瓣两端的第二显影区220位置重合时，可以确定介入二尖瓣的植入位置和姿态准确。由此，通过第一显影区210和第二显影区220的配合，使术者能够快速准确地调节介入二尖瓣的植入状态，实现了介入瓣膜1的精准植入。
作为一种具体的实现方式，该介入瓣膜1还包括载体，微粒可以固定于载体，载体固定于显影区200。其中，载体的材料可以为布，微粒可以固定嵌设于载体上，嵌设有微粒的载体可以整体固定于显影区200，从而可以方便在瓣架100或瓣裙上设置微粒。本实施例中，为了便于载体的固定，载体优选固定在瓣裙上，载体的材料可以与瓣裙相同，而微粒的材料与载体的材料不同，从而能够避免在超声图像中载体对微粒的干扰。
其中，载体的形状可以为点状、线状或面状。微粒可以在载体上均匀分布，以使微粒在超声图像中的成像能够形成与载体形状相近的形状，便于术者识别和区分。
以上所述仅为本申请的优选实施例而已，并不用于限制本申请，对于本领域的技术人员来说，本申请可以有各种更改和变化。凡在本申请的精神和原则之内，所作的任何修改、等同替换、改进等，均应包含在本申请的保护范围之内。

Claims (10)

  1. 一种可在超声显影引导下植入的介入瓣膜，其特征在于，包括瓣架(100)和瓣裙，所述瓣裙固定覆盖于所述瓣架(100)内壁；
    其中，所述瓣架(100)和/或所述瓣裙上设置有显影区(200)，所述显影区(200)的材料粗糙度大于位于所述显影区(200)以外区域的材料粗糙度；和/或，所述显影区(200)设置有微粒，所述微粒的材料不同于所述显影区(200)的材料。
  2. 根据权利要求1所述的可在超声显影引导下植入的介入瓣膜，其特征在于，所述微粒的材料与所述瓣架或所述瓣裙的材料在超声显影下的对比度不同；
    所述微粒的材料为金属材料、高分子材料、玻璃、陶瓷中的一种或多种。
  3. 根据权利要求1所述的可在超声显影引导下植入的介入瓣膜，其特征在于，所述微粒为球体、椭球体、柱状体或多面体形状。
  4. 根据权利要求1所述的可在超声显影引导下植入的介入瓣膜，其特征在于，所述微粒为球体，所述微粒的直径为50～80μm。
  5. 根据权利要求1所述的可在超声显影引导下植入的介入瓣膜，其特征在于，所述微粒粘接于所述显影区(200)的表面。
  6. 根据权利要求1-5任一项所述的可在超声显影引导下植入的介入瓣膜，其特征在于，所述显影区(200)为点状、线状或面状。
  7. 根据权利要求1-5任一项所述的可在超声显影引导下植入的介入瓣膜，其特征在于，所述介入瓣膜为介入二尖瓣，所述介入二尖瓣包括长轴和短轴，所述瓣架(100)在撑开状态下，所述瓣架(100)的一端形成有外翻结构(110)；所述显影区(200)包括第一显影区(210)和第二显影区(220)；
    沿所述介入二尖瓣的长轴方向，所述外翻结构(110)的两端设置有所述第一显影区(210)，所述第一显影区(210)为线状；
    沿所述介入二尖瓣的短轴方向，所述外翻结构(110)的两端设置有所述第二显影区(220)，所述第二显影区(220)为点状。
  8. 根据权利要求1所述的可在超声显影引导下植入的介入瓣膜，其特征在于，还包括载体，所述微粒固定于所述载体，所述载体固定于所述显影区(200)。
  9. 根据权利要求8所述的可在超声显影引导下植入的介入瓣膜，其特征在于，所述载体的形状为点状、线状或面状。
  10. 根据权利要求1所述的可在超声显影引导下植入的介入瓣膜，其特征在于，所述显影区(200)的表面形成有凸棱、凸点、凹坑或凹槽。
PCT/CN2022/071572 2022-01-12 2022-01-12 可在超声显影引导下植入的介入瓣膜 WO2023133724A1 (zh)

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US20080051702A1 (en) * 2006-08-24 2008-02-28 Herrmann Robert A Therapeutic agent delivery for the treatment of asthma via implantable and insertable medical devices
CN105050544A (zh) * 2013-03-15 2015-11-11 W.L.戈尔及同仁股份有限公司 改进的小叶和瓣膜装置
CN106175987A (zh) * 2016-08-31 2016-12-07 上海纽脉医疗科技有限公司 人工心脏瓣膜
CN112022440A (zh) * 2020-08-28 2020-12-04 金仕生物科技（常熟）有限公司 一种人工心脏瓣膜
CN213724309U (zh) * 2020-08-14 2021-07-20 上海鹏冠生物医药科技有限公司 一种可超声显影的介入导丝及插管

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US20080051702A1 (en) * 2006-08-24 2008-02-28 Herrmann Robert A Therapeutic agent delivery for the treatment of asthma via implantable and insertable medical devices
CN105050544A (zh) * 2013-03-15 2015-11-11 W.L.戈尔及同仁股份有限公司 改进的小叶和瓣膜装置
CN106175987A (zh) * 2016-08-31 2016-12-07 上海纽脉医疗科技有限公司 人工心脏瓣膜
CN213724309U (zh) * 2020-08-14 2021-07-20 上海鹏冠生物医药科技有限公司 一种可超声显影的介入导丝及插管
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