[go: up one dir, main page]

CN116570338B - Left auricle occluder and placement method - Google Patents

Left auricle occluder and placement method Download PDF

Info

Publication number
CN116570338B
CN116570338B CN202310855093.5A CN202310855093A CN116570338B CN 116570338 B CN116570338 B CN 116570338B CN 202310855093 A CN202310855093 A CN 202310855093A CN 116570338 B CN116570338 B CN 116570338B
Authority
CN
China
Prior art keywords
blocking
atrial appendage
left atrial
stent
unit
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Active
Application number
CN202310855093.5A
Other languages
Chinese (zh)
Other versions
CN116570338A (en
Inventor
陈增胜
徐亚为
樊瑜波
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Beihang University
Original Assignee
Beihang University
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Beihang University filed Critical Beihang University
Priority to CN202310855093.5A priority Critical patent/CN116570338B/en
Publication of CN116570338A publication Critical patent/CN116570338A/en
Application granted granted Critical
Publication of CN116570338B publication Critical patent/CN116570338B/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B17/12Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12099Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
    • A61B17/12122Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder within the heart
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B17/12Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12027Type of occlusion
    • A61B17/12031Type of occlusion complete occlusion
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B17/12Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/12168Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure
    • A61B17/12172Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure having a pre-set deployed three-dimensional shape
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B17/12Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/12168Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure
    • A61B17/12177Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure comprising additional materials, e.g. thrombogenic, having filaments, having fibers or being coated
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B17/12Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B2017/1205Introduction devices

Landscapes

  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biomedical Technology (AREA)
  • Medical Informatics (AREA)
  • Vascular Medicine (AREA)
  • Reproductive Health (AREA)
  • Engineering & Computer Science (AREA)
  • Veterinary Medicine (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Cardiology (AREA)
  • Surgical Instruments (AREA)

Abstract

The invention discloses a left auricle plugging device which comprises a plugging unit and a grapple unit, wherein the plugging unit can be contracted and expanded, when the plugging device is placed, the plugging unit is in a contracted state, and after the grapple unit is fixed on a comb muscle in a special form in a human left auricle, the plugging unit is expanded to plug the human left auricle. According to the left auricle plugging device, the grapple units are detachably connected with the plugging units, and the grapple units with proper specifications can be selected according to actual conditions so as to adapt to different patients, improve the flexibility and adaptability of the plugging device, and reduce the damage to the patients caused by placing the plugging device. Meanwhile, the grapple unit is fixed on the comb muscle in a special form in the left auricle of the human body, so that the placement stability of the left auricle occluder is improved, the situation that the left auricle occluder leaks or falls off is prevented, the occlusion reliability is improved, and meanwhile, the inner wall of the left auricle of the human body is prevented from being punctured and fixed. The invention also provides a placement method of the left auricle occluder.

Description

一种左心耳封堵器及放置方法A kind of left atrial appendage occlusion device and placement method

技术领域Technical field

本发明涉及医疗器械技术领域,特别是涉及一种左心耳封堵器及放置方法。The present invention relates to the technical field of medical devices, and in particular to a left atrial appendage occluder and a placement method.

背景技术Background technique

对于房颤患者或有高CHA2DS2-VASc分数(房颤卒中风险评分)的患者,左心耳封堵器通常用来对患者的左心耳进行封堵以达到与左心房隔绝,防止左心耳内脱落的血栓进入血液循环引发栓塞事件。左心耳封堵器是一种由金属支架和聚合物膜构成的笼状或塞状装置,装置的金属结构主要包括封堵盘、封堵网两部分。封堵盘和封堵网内均有封堵膜。封堵盘呈圆筒网状结构,封堵膜固定且覆盖在封堵盘内壁,封堵网呈圆饼网状结构,封堵膜固定且覆盖在封堵网内壁。封堵盘和封堵网通过各自中心的底座使用连接杆或支架连接。For patients with atrial fibrillation or those with high CHA 2 DS 2 -VASc scores (atrial fibrillation stroke risk scores), LAA occluders are often used to seal the patient's LAA to isolate it from the left atrium and prevent LAA The detached thrombus enters the blood circulation and causes an embolism event. The left atrial appendage occluder is a cage-like or plug-like device composed of a metal stent and a polymer membrane. The metal structure of the device mainly includes an occluder disc and an occluder mesh. There are blocking membranes in both the blocking disk and the blocking net. The blocking disk has a cylindrical mesh structure, and the blocking film is fixed and covers the inner wall of the blocking disk. The blocking net has a round cake mesh structure, and the blocking film is fixed and covers the inner wall of the blocking net. The sealing disk and the sealing net are connected by connecting rods or brackets through the bases in their respective centers.

左心耳封堵器的封堵功能由封堵盘和封堵网以及其中的封堵膜共同实现,其中封堵盘实现封堵器与左心耳内部的位置固定,封堵网位于心房内,作用是心房内皮细胞将封堵器在左心房部分内皮化的结构基础,同时也具有固定作用。封堵盘和封堵网的共同作用使左心耳封堵器在左心耳位于左心房的开口处实现双向固定-封堵器向左心耳内运动受封堵网阻碍,向左心房内运动受锚定钩牵拉。封堵盘和封堵网中的由聚四氟乙烯制成的封堵膜,允许红细胞通过,同时阻止脱落的血栓从左心耳进入左心房。The blocking function of the left atrial appendage occluder is realized by the blocking disc, the blocking net, and the blocking membrane. The blocking disc fixes the position of the occluder and the inside of the left atrial appendage. The blocking net is located in the atrium. It is the structural basis for the atrial endothelial cells to endothelialize the occluder in the left atrium, and it also has a fixation effect. The joint action of the occlusion disk and the occlusion net enables the LAA occluder to be bidirectionally fixed at the opening of the LAA in the left atrium - the movement of the occluder into the LAA is hindered by the occluder net, and its movement into the left atrium is anchored. Fixed hook pulling. The occluding membrane made of polytetrafluoroethylene in the occluding disc and mesh allows the passage of red blood cells while preventing the dislodged thrombus from entering the left atrium from the left atrial appendage.

左心耳封堵器在未放置时,折叠伞状存放在输送鞘中,封堵盘封堵网由镍钛合金制成,具有延展性和记忆,可在释放后分别展开成塞状结构和网状结构。When the left atrial appendage occluder is not placed, it is stored in a folded umbrella shape in the delivery sheath. The occluder disc occluder mesh is made of nickel-titanium alloy and has malleability and memory. It can be expanded into a plug-like structure and mesh after release. shape structure.

在左心耳封堵器放置过程中,输送鞘将折叠的封堵器由左心房输送到左心耳内,在实时造影下通过定位环确定输送鞘顶端与左心耳的相对位置,向左心耳深部推动封堵器底端连接导丝,同时后撤输送鞘,将左心耳封堵器从输送鞘中释放。封堵盘在左心耳内展开,呈塞状结构,结构的金属支撑杆上有锚定钩,手术医生扯动导丝封堵器使封堵盘上锚定钩刺入左心耳内壁实现封堵器的固定。继续后撤输送鞘,展开封堵网,封堵网从左心房一侧覆盖左心耳口。若放置位置不佳,需要重新放置,则前推输送鞘,使左心耳封堵器在输送鞘开口压迫下失去支撑功能,伞状折叠回输送鞘内,实现回收功能,以便重新放置。放置成功后旋掉导丝,撤出输送鞘,完成左心耳封堵器的放置。During the placement of the left atrial appendage occluder, the delivery sheath transports the folded occluder from the left atrium into the left atrial appendage. The relative position of the top of the delivery sheath and the left atrial appendage is determined through the positioning ring under real-time angiography, and the delivery sheath is pushed deep into the left atrial appendage. The bottom end of the occluder is connected to the guide wire, and the delivery sheath is withdrawn at the same time to release the left atrial appendage occluder from the delivery sheath. The occlusion disc is deployed in the left atrial appendage, forming a plug-like structure. There are anchor hooks on the metal support rods of the structure. The surgeon pulls the guidewire occluder to make the anchor hooks on the occlusion disc penetrate into the inner wall of the left atrial appendage to achieve closure. device fixation. Continue to withdraw the delivery sheath, unfold the blocking net, and cover the left atrial appendage opening from the left atrium side. If the placement is not good and needs to be repositioned, push the delivery sheath forward so that the left atrial appendage occluder loses its support function under the pressure of the delivery sheath opening, and folds back into the delivery sheath in an umbrella shape to realize the recovery function for relocation. After successful placement, unscrew the guidewire, withdraw the delivery sheath, and complete the placement of the left atrial appendage occlusion device.

人体左心耳结构复杂多样,左心耳内壁有由梳状肌构成的沟壑,在部分患者的心脏结构中,存在两端连接左心耳内壁、中部不与左心耳内壁连接的特殊形态的梳状肌。在名为HeartRhythm的期刊中,2013年刊登的文章:Anatomical characteristics of the leftatrial appendage in cardiogenic stroke with low CHADS2 scores(DOI:10.1016/j.hrthm.2013.01.036),文章最后的图像中,标号为“H”的图像体现了此类特殊形态的梳状肌对左心耳内血液流场的影响,此图证明了左心耳内存在此种生理结构,即特殊形态的梳状肌的存在。如果左心耳封堵器在放置时受梳状肌影响不能完全贴合左心耳内壁,在封堵器和左心耳内壁间存在缝隙,脱落的血栓存在进入左心房随血液进入全身血管的风险,可能导致患者发生栓塞事件。The structure of the human left atrial appendage is complex and diverse. The inner wall of the left atrial appendage has ravines composed of pectinate muscles. In the heart structure of some patients, there is a special shape of the pectinate muscle that is connected to the inner wall of the left atrial appendage at both ends and is not connected to the inner wall of the left atrial appendage in the middle. In the journal called HeartRhythm, an article was published in 2013: Anatomical characteristics of the leftatrial appendage in cardiogenic stroke with low CHADS 2 scores (DOI: 10.1016/j.hrthm.2013.01.036). In the image at the end of the article, the label is The image of "H" reflects the influence of this special shape of pectinate muscle on the blood flow field in the left atrial appendage. This picture proves the existence of this physiological structure in the left atrial appendage, that is, the existence of a special shape of pectinate muscle. If the left atrial appendage occluder cannot fully fit the inner wall of the left atrial appendage due to the pectinate muscles during placement, there will be a gap between the occluder and the inner wall of the left atrial appendage, and there is a risk that the detached thrombus will enter the left atrium and enter the systemic blood vessels along with the blood. leading to embolic events in patients.

尽管在结构设计上进行了多种优化,左心耳封堵器的结构从单独的塞状结构到由封堵盘、封堵网两部分结构组成,进一步增加了对脱落血栓的拦阻成功率,优化了左心房对做左心耳封堵器的内皮化过程。目前左心耳封堵器放置时,为使锚定钩稳定刺入左心耳内壁,以达到固定封堵盘的效果,需要手术医生向左心耳外牵拉,使左心耳封堵器整体放置位置在左心房左心耳中偏向左心房一侧,封堵网原本应紧密贴合覆盖左心耳开口,但由于牵拉导致覆盖不严密,造成封堵网和心房壁之间存在缝隙,形成渗漏并可能发生DRT(device-related thrombosis设备相关血栓)。同时,用力牵拉封堵盘,可能导致封堵盘上锚定钩对左心耳内壁造成撕裂伤害。若放置位置不佳还需要收回封堵盘,再次将锚定钩刺入左心耳内壁,重新进行“释放展开-牵拉-刺入”这一过程,可能对患者造成更大伤害。目前的左心耳封堵器可对封堵网和封堵盘的直径进行更改,但由于人体左心耳结构复杂多样,仍存在适应性较差的问题,放置过程仍然易对患者造成伤害。Although various optimizations have been made in the structural design, the structure of the left atrial appendage occluder has changed from a separate plug-like structure to a two-part structure consisting of a blocking disk and a blocking net, which further increases the success rate of blocking detached thrombi and optimizes The endothelialization process of the left atrium for the left atrial appendage occluder was analyzed. At present, when the left atrial appendage occluder is placed, in order to stably pierce the inner wall of the left atrial appendage with the anchor hook and achieve the effect of fixing the occluded disc, the surgeon needs to pull the left atrial appendage outward so that the overall placement position of the left atrial appendage occluder is at The left atrial appendage of the left atrium is biased toward the left atrium side. The blocking net should have been tightly fitted to cover the opening of the left atrial appendage. However, due to traction, the coverage was not tight, resulting in a gap between the blocking net and the atrial wall, causing leakage and possibly DRT (device-related thrombosis device-related thrombosis) occurs. At the same time, pulling the occlusion disc with force may cause the anchor hook on the occlusion disc to tear the inner wall of the left atrial appendage. If the placement is not good, the blocking disk needs to be retracted, the anchoring hook is inserted into the inner wall of the left atrial appendage again, and the process of "release, deployment, pulling, and insertion" is repeated, which may cause greater harm to the patient. The current left atrial appendage occluder can change the diameter of the occluder net and occluder disk. However, due to the complex and diverse structure of the human left atrial appendage, there is still the problem of poor adaptability, and the placement process is still easy to cause harm to the patient.

因此,如何改变现有技术中,左心耳封堵器适应性不佳易对患者造成伤害的现状,成为了本领域技术人员亟待解决的问题。Therefore, how to change the current situation in the existing technology that the left atrial appendage occluder has poor adaptability and easily causes harm to patients has become an urgent problem for those skilled in the art to solve.

发明内容Contents of the invention

本发明的目的是提供一种左心耳封堵器及放置方法,以解决上述现有技术存在的问题,提高左心耳封堵器的适应性,降低放置封堵器对患者造成的伤害。The purpose of the present invention is to provide a left atrial appendage occluder and a placement method to solve the above-mentioned problems existing in the prior art, improve the adaptability of the left atrial appendage occluder, and reduce the harm caused to patients by placing the occluder.

为实现上述目的,本发明提供了如下方案:本发明提供一种左心耳封堵器,包括:In order to achieve the above object, the present invention provides the following solutions: The present invention provides a left atrial appendage occluding device, including:

封堵单元,所述封堵单元能够收缩和展开,且所述封堵单元展开时能够封堵人体左心耳;A blocking unit, the blocking unit can be contracted and expanded, and when expanded, the blocking unit can block the left atrial appendage of the human body;

抓钩单元,所述抓钩单元与所述封堵单元可拆卸连接,且所述抓钩单元能够固定在人体左心耳内的特殊形态的梳状肌上。The grapple unit is detachably connected to the blocking unit, and the grapple unit can be fixed on the special-shaped pectinate muscle in the left atrial appendage of the human body.

优选地,所述封堵单元包括第一封堵膜、支架组件和第二封堵膜,所述第一封堵膜利用所述支架组件与所述第二封堵膜相连,所述第一封堵膜、所述支架组件以及所述第二封堵膜均由弹性材质制成,在自由状态下,所述第一封堵膜和所述第二封堵膜均为碗状结构,且二者的开口均朝向远离所述支架组件的方向设置。Preferably, the blocking unit includes a first blocking membrane, a stent assembly and a second blocking membrane, the first blocking membrane is connected to the second blocking membrane using the stent assembly, and the first blocking membrane The blocking film, the stent assembly and the second blocking film are all made of elastic material. In the free state, the first blocking film and the second blocking film are bowl-shaped structures, and The openings of both are arranged in a direction away from the bracket assembly.

优选地,所述支架组件包括内支架丝、内支架底座、外支架丝以及外支架底座,所述内支架底座位于所述第一封堵膜的收口端且二者相连,所述内支架丝的一端与所述第一封堵膜的开口端相连,另一端与所述内支架底座相连;所述外支架底座位于所述第二封堵膜的收口端且二者相连,所述外支架丝连接所述第一封堵膜与所述外支架底座。Preferably, the stent assembly includes an inner stent wire, an inner stent base, an outer stent wire and an outer stent base. The inner stent base is located at the closing end of the first sealing membrane and is connected to each other. The inner stent wire One end is connected to the opening end of the first blocking film, and the other end is connected to the inner bracket base; the outer bracket base is located at the closing end of the second blocking membrane and the two are connected, and the outer bracket Wires connect the first blocking membrane and the outer stent base.

优选地,所述内支架丝和所述外支架丝的数量均为多根,所述内支架丝以及所述外支架丝绕所述第一封堵膜、所述第二封堵膜的轴线周向均布。Preferably, the number of the inner stent wires and the outer stent wires is multiple, and the inner stent wires and the outer stent wires surround the axes of the first blocking film and the second blocking film. Evenly distributed in circumferential direction.

优选地,所述内支架丝的形状与所述第一封堵膜的外形轮廓相一致;所述外支架丝还连接有辅助支架丝,所述辅助支架丝设置于相邻的两根所述外支架丝之间,所述辅助支架丝为X形。Preferably, the shape of the inner stent wire is consistent with the outline of the first blocking membrane; the outer stent wire is also connected to an auxiliary stent wire, and the auxiliary stent wire is arranged on two adjacent ones of the Between the outer stent wires, the auxiliary stent wires are X-shaped.

优选地,所述封堵单元还包括封堵网,所述封堵网罩设于所述第二封堵膜的外部,所述封堵网的形状与所述第二封堵膜匹配,所述封堵网的收口端与所述外支架底座相连,所述封堵网由镍钛合金丝编织制成。Preferably, the blocking unit further includes a blocking net, the blocking net cover is provided outside the second blocking film, and the shape of the blocking net matches the second blocking film, so The closing end of the blocking net is connected to the base of the outer bracket, and the blocking net is made of woven nickel-titanium alloy wire.

优选地,所述内支架底座以及所述外支架底座均能够与输送鞘的导丝可拆装连接。Preferably, both the inner stent base and the outer stent base can be detachably connected to the guide wire of the delivery sheath.

优选地,所述抓钩单元包括依次相连的抓钩底座、弹簧、抓杆以及钩环,所述抓钩底座与所述封堵单元可拆卸连接,所述钩环能够钩挂在人体左心耳内的特殊形态的梳状肌上并实现固定。Preferably, the grapple unit includes a grapple base, a spring, a grapple rod and a shackle connected in sequence. The grapple base is detachably connected to the blocking unit, and the shackle can be hooked on the left atrial appendage of the human body. It is fixed on the special shape of the pectinate muscle inside.

优选地,所述钩环为具有缺口的环状结构,所述钩环的数量为多个,多个所述钩环绕所述抓杆的轴线周向均布。Preferably, the shackles are annular structures with notches, the number of shackles is multiple, and the plurality of hooks are evenly distributed around the axis of the grab bar.

本发明还提供一种上述的左心耳封堵器的放置方法,使所述封堵单元处于收缩状态,将所述左心耳封堵器输送至人体左心耳内,将抓钩单元远离所述封堵单元的一端固定在人体左心耳内的特殊形态的梳状肌上,使所述封堵单元展开,所述封堵单元封堵人体左心耳。The present invention also provides a method for placing the above-mentioned left atrial appendage occluder, which puts the occluder unit in a contracted state, transports the left atrial appendage occluder into the left atrial appendage of the human body, and moves the grapple unit away from the occluder unit. One end of the blocking unit is fixed on the pectinate muscle of a special shape in the left atrial appendage of the human body, so that the blocking unit is deployed, and the blocking unit blocks the left atrial appendage of the human body.

本发明相对于现有技术取得了以下技术效果:Compared with the prior art, the present invention achieves the following technical effects:

本发明的左心耳封堵器,封堵单元能够收缩和展开,放置封堵器时,使封堵单元处于收缩状态,将抓钩单元固定在人体左心耳内的特殊形态的梳状肌上,使封堵单元展开,封堵人体左心耳。本发明的左心耳封堵器,抓钩单元与封堵单元可拆卸连接,可根据实际情况选择合适规格的抓钩单元,以适应不同的患者,提高封堵器的灵活适应性,降低放置封堵器对患者造成的伤害。同时,本发明的抓钩单元固定在人体左心耳内的特殊形态的梳状肌上,在部分患者的左心耳中,存在特殊形态的梳状肌,在房颤情况下,左心耳收缩功能消失,此类梳状肌不再具有收缩功能,是造成左心耳内血栓生成风险增加的原因之一,但梳状肌位置相对固定,且由于其为肌肉组织,具有一定坚韧性,作为固定左心耳封堵器的固定点,提高了左心耳封堵器的放置稳定性,防止左心耳封堵器发生渗漏或脱落的情况,提高封堵可靠性,且抓钩单元固定在人体左心耳内的特殊形态的梳状肌上,避免了对人体左心耳内壁进行刺破固定,从而进一步降低左心耳封堵器放置对患者造成的伤害。In the left atrial appendage occluder of the present invention, the occluder unit can contract and expand. When the occluder is placed, the occluder unit is in a contracted state, and the grapple unit is fixed on the special-shaped pectinate muscle in the left atrial appendage of the human body. The blocking unit is deployed to block the human left atrial appendage. In the left atrial appendage occluder of the present invention, the grapple unit and the occluder unit are detachably connected. The grapple unit of appropriate specifications can be selected according to the actual situation to adapt to different patients, improve the flexibility and adaptability of the occluder, and reduce the cost of placing the occluder. The harm caused by the occluder to the patient. At the same time, the grapple unit of the present invention is fixed on the special-shaped pectinate muscle in the left atrial appendage of the human body. In the left atrial appendage of some patients, there is a special-shaped pectinate muscle. In the case of atrial fibrillation, the contraction function of the left atrial appendage disappears. , this type of pectinate muscle no longer has the contractile function, which is one of the reasons for the increased risk of thrombus formation in the left atrial appendage. However, the position of the pectinate muscle is relatively fixed, and because it is a muscle tissue, it has a certain toughness, and it can be used as a fixed left atrial appendage. The fixed point of the occluder improves the placement stability of the left atrial appendage occluder, prevents the left atrial appendage occluder from leaking or falling off, improves the reliability of the occluder, and the grapple unit is fixed in the left atrial appendage of the human body. The special shape of the pectinate muscle avoids puncturing and fixing the inner wall of the human left atrial appendage, thereby further reducing the harm caused to the patient by placing the left atrial appendage occluder.

本发明还提供一种上述左心耳封堵器的放置方法,利用封堵单元对左心耳进行封堵,同时利用抓钩单元固定在人体左心耳内的特殊形态的梳状肌上,避免了对左心耳内皮的刺入,减小发生封堵手术中心包积液和心脏压塞并发症的发生。The present invention also provides a method for placing the above-mentioned left atrial appendage occluder. The occluder unit is used to occlude the left atrial appendage. At the same time, the grapple unit is used to fix the special-shaped pectinate muscle in the left atrial appendage of the human body to avoid damage to the left atrial appendage. Puncture of the left atrial appendage endothelium reduces the complications of pericardial effusion and cardiac tamponade during closure surgery.

附图说明Description of the drawings

为了更清楚地说明本发明实施例或现有技术中的技术方案,下面将对实施例中所需要使用的附图作简单地介绍,显而易见地,下面描述中的附图仅仅是本发明的一些实施例,对于本领域普通技术人员来讲,在不付出创造性劳动的前提下,还可以根据这些附图获得其他的附图。In order to explain the embodiments of the present invention or the technical solutions in the prior art more clearly, the drawings needed to be used in the embodiments will be briefly introduced below. Obviously, the drawings in the following description are only some of the drawings of the present invention. Embodiments, for those of ordinary skill in the art, other drawings can also be obtained based on these drawings without exerting creative efforts.

图1为本发明实施例所公开的左心耳封堵器的轴测图;Figure 1 is a isometric view of the left atrial appendage occluder disclosed in an embodiment of the present invention;

图2为本发明实施例所公开的左心耳封堵器的主视图;Figure 2 is a front view of the left atrial appendage occluder disclosed in the embodiment of the present invention;

图3为本发明实施例所公开的左心耳封堵器的俯视图;Figure 3 is a top view of the left atrial appendage occluder disclosed in the embodiment of the present invention;

图4为本发明实施例所公开的左心耳封堵器的侧视图;Figure 4 is a side view of the left atrial appendage occluder disclosed in the embodiment of the present invention;

图5为本发明实施例所公开的左心耳封堵器的抓钩单元的结构示意图;Figure 5 is a schematic structural diagram of the grapple unit of the left atrial appendage occluder disclosed in the embodiment of the present invention;

图6为本发明实施例所公开的左心耳封堵器的放置示意图。Figure 6 is a schematic diagram of the placement of the left atrial appendage occluder disclosed in the embodiment of the present invention.

其中,100为封堵单元,200为抓钩单元;Among them, 100 is the blocking unit and 200 is the grappling hook unit;

1为第一封堵膜,2为支架组件,3为第二封堵膜,4为内支架丝,5为内支架底座,6为外支架丝,7为外支架底座,8为辅助支架丝,9为封堵网,10为抓钩底座,11为弹簧,12为抓杆,13为钩环,14为扎线,15为输送鞘,16为导丝。1 is the first blocking membrane, 2 is the stent component, 3 is the second blocking membrane, 4 is the inner stent wire, 5 is the inner stent base, 6 is the outer stent wire, 7 is the outer stent base, and 8 is the auxiliary stent wire. , 9 is the blocking net, 10 is the grapple base, 11 is the spring, 12 is the grapple rod, 13 is the shackle, 14 is the tie line, 15 is the delivery sheath, and 16 is the guide wire.

具体实施方式Detailed ways

下面将结合本发明实施例中的附图,对本发明实施例中的技术方案进行清楚、完整地描述,显然,所描述的实施例仅仅是本发明一部分实施例,而不是全部的实施例。基于本发明中的实施例,本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例,都属于本发明保护的范围。The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are only some of the embodiments of the present invention, rather than all the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative efforts fall within the scope of protection of the present invention.

本发明的目的是提供一种左心耳封堵器及放置方法,以解决上述现有技术存在的问题,提高左心耳封堵器的适应性,降低放置封堵器对患者造成的伤害。The purpose of the present invention is to provide a left atrial appendage occluder and a placement method to solve the above-mentioned problems existing in the prior art, improve the adaptability of the left atrial appendage occluder, and reduce the harm caused to patients by placing the occluder.

为使本发明的上述目的、特征和优点能够更加明显易懂,下面结合附图和具体实施方式对本发明作进一步详细的说明。In order to make the above objects, features and advantages of the present invention more obvious and understandable, the present invention will be described in further detail below with reference to the accompanying drawings and specific embodiments.

本发明提供一种左心耳封堵器,包括封堵单元100和抓钩单元200,封堵单元100能够收缩和展开,且封堵单元100展开时能够封堵人体左心耳;抓钩单元200与封堵单元100可拆卸连接,且抓钩单元200能够固定在人体左心耳内的特殊形态的梳状肌上。The present invention provides a left atrial appendage occluding device, which includes a occluding unit 100 and a grapple unit 200. The occluding unit 100 can be contracted and expanded, and when expanded, the occluding unit 100 can seal the human left atrial appendage; the grapple unit 200 and The blocking unit 100 is detachably connected, and the grapple unit 200 can be fixed on the special-shaped pectinate muscle in the left atrial appendage of the human body.

本发明的左心耳封堵器,封堵单元100能够收缩和展开,放置封堵器时,使封堵单元100处于收缩状态,将抓钩单元200固定在人体左心耳内的特殊形态的梳状肌上,使封堵单元100展开,封堵人体左心耳。本发明的左心耳封堵器,抓钩单元200与封堵单元100可拆卸连接,可根据实际情况选择合适规格的抓钩单元200,以适应不同的患者,提高封堵器的灵活适应性,降低放置封堵器对患者造成的伤害。同时,本发明的抓钩单元200固定在人体左心耳内的特殊形态的梳状肌上,在部分患者的左心耳中,存在特殊形态的梳状肌,在房颤情况下,左心耳收缩功能消失,此类梳状肌不再具有收缩功能,是造成左心耳内血栓生成风险增加的原因之一,但梳状肌位置相对固定,且由于其为肌肉组织,具有一定坚韧性,作为固定左心耳封堵器的固定点,提高了左心耳封堵器的放置稳定性,防止左心耳封堵器发生渗漏或脱落的情况,提高封堵可靠性,且抓钩单元200固定在人体左心耳内的特殊形态的梳状肌上,避免了对人体左心耳内壁进行刺破固定,从而进一步降低左心耳封堵器放置对患者造成的伤害。In the left atrial appendage occluder of the present invention, the occluder unit 100 can be contracted and expanded. When the occluder is placed, the occluder unit 100 is in a contracted state, and the grapple unit 200 is fixed in a special comb shape in the left atrial appendage of the human body. On the muscle, the blocking unit 100 is deployed to block the left atrial appendage of the human body. In the left atrial appendage occluder of the present invention, the grapple unit 200 and the occluder unit 100 are detachably connected. The grapple unit 200 of appropriate specifications can be selected according to the actual situation to adapt to different patients and improve the flexibility and adaptability of the occluder. Reduce the harm caused to the patient by placing the occluder. At the same time, the grapple unit 200 of the present invention is fixed on the special-shaped pectinate muscle in the left atrial appendage of the human body. In the left atrial appendage of some patients, there is a special-shaped pectinate muscle. In the case of atrial fibrillation, the left atrial appendage contraction function disappear, this type of pectinate muscle no longer has the contraction function, which is one of the reasons for the increased risk of thrombus formation in the left atrial appendage. However, the position of the pectinate muscle is relatively fixed, and because it is a muscle tissue, it has a certain toughness. As a fixed left atrial appendage, it has a certain toughness. The fixed point of the atrial appendage occluder improves the placement stability of the left atrial appendage occluder, prevents the left atrial appendage occluder from leaking or falling off, and improves the reliability of the occluder, and the grapple unit 200 is fixed on the left atrial appendage of the human body. The special shape of the pectinate muscle in the device avoids puncturing and fixing the inner wall of the human left atrial appendage, thereby further reducing the harm caused to the patient by placing the left atrial appendage occluder.

具体地,封堵单元100包括第一封堵膜1、支架组件2和第二封堵膜3,第一封堵膜1利用支架组件2与第二封堵膜3相连,第一封堵膜1、支架组件2以及第二封堵膜3均由弹性材质制成,以使封堵单元100能够收缩,方便利用输送鞘15输送左心耳封堵器,在自由状态下,第一封堵膜1和第二封堵膜3均为碗状结构,且二者的开口均朝向远离支架组件2的方向设置,在封堵器输送到位后,且抓钩单元200固定在人体左心耳内的特殊形态的梳状肌上后,撤去输送鞘15,封堵单元100在弹性作用下自动展开,封堵人体左心耳。Specifically, the blocking unit 100 includes a first blocking membrane 1, a bracket assembly 2 and a second blocking membrane 3. The first blocking membrane 1 is connected to the second blocking membrane 3 using the bracket assembly 2. The first blocking membrane 1. The stent assembly 2 and the second blocking membrane 3 are both made of elastic material, so that the blocking unit 100 can be contracted to facilitate the use of the delivery sheath 15 to transport the left atrial appendage occluder. In the free state, the first blocking membrane 1 and the second occluding membrane 3 are both bowl-shaped structures, and the openings of both are set in a direction away from the stent assembly 2. After the occluder is delivered in place, the grapple unit 200 is fixed in the special left atrial appendage of the human body. After the pectinate muscle is attached, the delivery sheath 15 is removed, and the blocking unit 100 automatically expands under the action of elasticity to block the left atrial appendage of the human body.

更具体地,支架组件2包括内支架丝4、内支架底座5、外支架丝6以及外支架底座7,内支架底座5位于第一封堵膜1的收口端且二者相连,内支架丝4的一端与第一封堵膜1的开口端相连,另一端与内支架底座5相连,利用内支架丝4支撑第一封堵膜1;外支架底座7位于第二封堵膜3的收口端且二者相连,第一封堵膜1利用外支架丝6与外支架底座7相连,提高封堵器的整体结构强度。More specifically, the stent assembly 2 includes an inner stent wire 4, an inner stent base 5, an outer stent wire 6 and an outer stent base 7. The inner stent base 5 is located at the closing end of the first sealing membrane 1 and is connected to each other. The inner stent wire One end of 4 is connected to the open end of the first blocking membrane 1, and the other end is connected to the inner bracket base 5. The inner bracket wire 4 is used to support the first blocking membrane 1; the outer bracket base 7 is located at the closing end of the second blocking membrane 3 The first blocking membrane 1 is connected to the outer bracket base 7 by using the outer bracket wire 6 to improve the overall structural strength of the blocking device.

为了进一步地增强封堵器的结构稳定性,内支架丝4和外支架丝6的数量均为多根,内支架丝4以及外支架丝6绕第一封堵膜1、第二封堵膜3的轴线周向均布,保证封堵单元100结构强度,同时提高第一封堵膜1与外支架底座7的受力均匀性。In order to further enhance the structural stability of the occluder, there are multiple inner stent wires 4 and multiple outer stent wires 6. The inner stent wires 4 and the outer stent wires 6 surround the first blocking membrane 1 and the second blocking membrane. 3 is evenly distributed in the circumferential direction to ensure the structural strength of the blocking unit 100 and at the same time improve the force uniformity between the first blocking membrane 1 and the outer bracket base 7 .

在本具体实施方式中,内支架丝4的形状与第一封堵膜1的外形轮廓相一致,以增强内支架丝4对第一封堵膜1的支撑稳定性,进而提高封堵器的封堵可靠性。为了进一步提高支架组件2的支撑稳定性和可靠性,外支架丝6还连接有辅助支架丝8,辅助支架丝8设置于相邻的两根外支架丝6之间,辅助支架丝8为X形,辅助支架丝8的一端与外支架丝6靠近第一封堵膜1的一端连接,辅助支架丝8的另一端与外支架丝6靠近外支架底座7的一端连接,辅助支架丝8与外支架丝6相配合形成支撑网架,在确保支架组件2能够随第一封堵膜1、第二封堵膜3收缩的同时,保证封堵单元100展开状态下的结构稳定性。此处还需要说明的是,为了增强外支架丝6与第一封堵膜1的连接牢固性,利用扎线14将第一封堵膜1的边缘固定在外支架丝6上,保证连接牢固的同时,还能够利用扎线14增强支架组件2对第一封堵膜1的支撑作用。In this specific embodiment, the shape of the inner stent wire 4 is consistent with the outline of the first blocking membrane 1 to enhance the support stability of the inner stent wire 4 to the first blocking membrane 1 and thereby improve the performance of the occluder. Blocking reliability. In order to further improve the support stability and reliability of the bracket assembly 2, the outer bracket wire 6 is also connected to an auxiliary bracket wire 8. The auxiliary bracket wire 8 is arranged between two adjacent outer bracket wires 6. The auxiliary bracket wire 8 is X Shape, one end of the auxiliary stent wire 8 is connected to the end of the outer stent wire 6 close to the first blocking membrane 1, the other end of the auxiliary stent wire 8 is connected to the end of the outer stent wire 6 close to the outer stent base 7, the auxiliary stent wire 8 is connected to The outer stent wires 6 cooperate to form a support grid, which ensures that the stent assembly 2 can shrink with the first blocking film 1 and the second blocking film 3 while ensuring the structural stability of the blocking unit 100 in the unfolded state. It should also be noted here that in order to enhance the firmness of the connection between the outer stent wire 6 and the first blocking membrane 1 , the edge of the first blocking membrane 1 is fixed on the outer stent wire 6 using tie wires 14 to ensure a firm connection. At the same time, the tie wires 14 can also be used to enhance the supporting effect of the stent assembly 2 on the first blocking membrane 1 .

同时,封堵单元100还包括封堵网9,封堵网9罩设于第二封堵膜3的外部,封堵网9的形状与第二封堵膜3匹配,封堵网9能够对第二封堵膜3提供稳定支撑,以保证第一封堵膜1和第二封堵膜3相配合能够封堵人体左心耳,避免泄漏,封堵网9的收口端与外支架底座7相连,在本具体实施方式中,封堵网9由镍钛合金丝编织制成,使得封堵网9能够随第二封堵膜3收缩和展开,封堵网9在具备延展性的同时具有记忆,在第二封堵膜3展开时能够展开形成网状结构,以支撑第二封堵膜3。在本发明的其他具体实施方式中,还可以选择其他材质制作封堵网9,以满足不同的工况,进一步提高封堵器的灵活适应性。At the same time, the blocking unit 100 also includes a blocking net 9. The blocking net 9 is covered outside the second blocking film 3. The shape of the blocking net 9 matches the second blocking film 3. The blocking net 9 can The second blocking membrane 3 provides stable support to ensure that the first blocking membrane 1 and the second blocking membrane 3 can cooperate to block the human left atrial appendage and avoid leakage. The closing end of the blocking net 9 is connected to the outer stent base 7 , in this specific embodiment, the blocking net 9 is made of woven nickel-titanium alloy wire, so that the blocking net 9 can shrink and expand with the second blocking film 3. The blocking net 9 has ductility and memory at the same time. , when the second blocking film 3 is unfolded, it can be unfolded to form a network structure to support the second blocking film 3 . In other specific embodiments of the present invention, other materials can also be selected to make the blocking net 9 to meet different working conditions and further improve the flexibility and adaptability of the blocking device.

还需要说明的是,内支架底座5以及外支架底座7均能够与输送鞘15的导丝16可拆装连接,以实现利用输送鞘15的导丝16带动封堵器顺利到达输送位置并完成封堵器的释放。在本具体实施方式中,内支架底座5以及外支架底座7均能够与导丝16螺纹连接,连接紧固,拆装便捷,在导丝16与内支架底座5螺纹相连时,导丝16穿过外支架底座7,进一步提高操作便捷性。It should also be noted that both the inner stent base 5 and the outer stent base 7 can be detachably connected to the guide wire 16 of the delivery sheath 15, so that the guide wire 16 of the delivery sheath 15 can be used to drive the occluder to the delivery position smoothly and complete the process. Release of the occluder. In this specific embodiment, both the inner bracket base 5 and the outer bracket base 7 can be threadedly connected to the guide wire 16, and the connection is tight and easy to disassemble and assemble. When the guide wire 16 is threadedly connected to the inner bracket base 5, the guide wire 16 passes through The outer bracket base 7 is passed to further improve the convenience of operation.

除此之外,抓钩单元200包括依次相连的抓钩底座10、弹簧11、抓杆12以及钩环13,抓钩底座10与封堵单元100可拆卸连接,钩环13能够钩挂在特殊形态的梳状肌上(钩环13钩挂在特殊形态的梳状肌不与左心耳内壁相连的中部)以实现固定,在本具体实施方式中,抓钩底座10与内支架底座5可拆卸连接,抓钩底座10与抓杆12之间设置弹簧11,在固定钩环13操作时弹簧11能够起到缓冲作用,在实际应用中还可以根据实际操作需要选择其他类型的弹性件。In addition, the grapple unit 200 includes a grapple base 10, a spring 11, a grapple 12 and a shackle 13 connected in sequence. The grapple base 10 is detachably connected to the blocking unit 100, and the shackle 13 can be hooked on a special (the hook 13 is hooked on the middle part of the pectinate muscle of a special shape that is not connected to the inner wall of the left atrial appendage) to achieve fixation. In this specific embodiment, the grapple base 10 and the inner stent base 5 are detachable. Connection, a spring 11 is provided between the grapple base 10 and the grapple rod 12. The spring 11 can play a buffering role when the fixed hook ring 13 is operated. In practical applications, other types of elastic parts can also be selected according to actual operation needs.

还需要强调的是,钩环13为具有缺口的环状结构,使得钩环13能够钩住特殊形态的梳状肌,方便操作的同时,尽可能地保证抓取稳定性,在本具体实施方式中,钩环13所对应的圆心角为270°,以保证抓取可靠,钩环13的缺口大小可根据特殊形态的梳状肌的尺寸进行调整。钩环13的数量为一个或多个,多个钩环13绕抓杆12的轴线周向均布,为了满足不同的固定需求,可设置多个抓钩单元200,每个抓钩单元200的钩环13的数量不同,抓钩底座10与内支架底座5螺纹连接,方便更换,提高左心耳封堵器的灵活适应性。It should also be emphasized that the shackle 13 is an annular structure with a gap, so that the shackle 13 can hook the pectinate muscle of a special shape, which facilitates operation while ensuring the grabbing stability as much as possible. In this specific embodiment, , the corresponding central angle of the hook 13 is 270° to ensure reliable grasping, and the gap size of the hook 13 can be adjusted according to the size of the special shape of the pectinate muscle. The number of shackles 13 is one or more, and multiple shackles 13 are evenly distributed around the axis of the grab rod 12. In order to meet different fixing requirements, multiple grab hook units 200 can be provided, and the shackles of each grab hook unit 200 The numbers 13 are different, and the grapple base 10 is threadedly connected to the inner stent base 5 to facilitate replacement and improve the flexibility and adaptability of the left atrial appendage occluder.

进一步地,本发明还提供一种上述的左心耳封堵器的放置方法,使封堵单元100处于收缩状态,将左心耳封堵器输送至人体左心耳内,将抓钩单元200远离封堵单元100的一端固定在人体左心耳内的特殊形态的梳状肌上,使封堵单元100展开,封堵单元100封堵人体左心耳,利用封堵单元100对左心耳进行封堵,同时利用抓钩单元200固定在人体左心耳内的特殊形态的梳状肌上,避免了对左心耳内皮的刺入,减小发生封堵手术中心包积液和心脏压塞并发症的发生。Further, the present invention also provides a method for placing the above-mentioned left atrial appendage occluder, which puts the occluder unit 100 in a contracted state, transports the left atrial appendage occluder into the left atrial appendage of the human body, and moves the grapple unit 200 away from the occluder. One end of the unit 100 is fixed on the special-shaped pectinate muscle in the left atrial appendage of the human body, so that the blocking unit 100 is unfolded, and the blocking unit 100 blocks the left atrial appendage of the human body. The blocking unit 100 is used to block the left atrial appendage, and at the same time, The grapple unit 200 is fixed on the special-shaped pectinate muscle in the left atrial appendage of the human body, which avoids penetration of the left atrial appendage endothelium and reduces the occurrence of complications such as pericardial effusion and cardiac tamponade during closure surgery.

在放置本发明的左心耳封堵器时,请参考图6,输送鞘15将收缩的左心耳封堵器输送至左心耳内,推动导丝16将收缩的左心耳封堵器从输送鞘15中推出,首先露出抓钩单元200,操纵导丝16和输送鞘15,使抓钩环13钩挂在特殊形态的梳状肌上(钩环13钩挂在特殊形态的梳状肌不与左心耳内壁相连的中部)以实现固定;抓取完成后,保持导丝16不动,后撤(使输送鞘15朝向远离左心耳的方向运动)输送鞘15,露出外支架丝6和封堵网9,旋转导丝16,使导丝16与内支架底座5分离后,将导丝16与外支架底座7旋紧二者连接,后撤输送鞘15至外支架底座7,此时输送鞘15对收缩的左心耳封堵器没有施加作用力,但封堵器在左心耳口的束缚下无法展开;继续后撤导丝16,使封堵网9完全撤出左心耳,封堵网9以及第二封堵膜3在自身弹力的作用下展开。同时,支架组件2失去封堵网9束缚,完全张开,六根外支架丝6牵引第一封堵膜1向左心耳内壁展开,同时给予内支架丝4展开的拉力,辅助支架丝8展开,支撑外支架丝6;内支架丝4在自身弹力作用下向四周撑开,并使外支架丝6以及第一封堵膜1边缘紧密贴合左心耳内壁,同时向左心耳封堵器施加朝向左心耳内部的拉力,使封堵网9紧密贴合在心房一侧,封堵左心耳口;旋转导丝16,使导丝16与外支架底座7分离,完成左心耳封堵器的放置。此处需要解释说明的是,输送鞘15以及导丝16均为本领域技术人员的惯用手段,此处不再赘述。When placing the left atrial appendage occluder of the present invention, please refer to Figure 6. The delivery sheath 15 transports the contracted left atrial appendage occluder into the left atrial appendage, and the guide wire 16 is pushed to remove the contracted left atrial appendage occluder from the delivery sheath 15. Push it out, first expose the grapple unit 200, manipulate the guide wire 16 and the delivery sheath 15, so that the grapple ring 13 is hooked on the special shape of the pectinate muscle (the hook ring 13 is hooked on the special shape of the pectinate muscle and is not in contact with the left The middle part where the inner wall of the atrial appendage is connected) to achieve fixation; after the grasping is completed, keep the guide wire 16 motionless and withdraw (move the delivery sheath 15 away from the left atrial appendage) the delivery sheath 15 to expose the external stent wire 6 and the blocking net 9. Rotate the guide wire 16 to separate the guide wire 16 from the inner stent base 5. Tighten the guide wire 16 and the outer stent base 7 to connect them. Then withdraw the delivery sheath 15 to the outer stent base 7. At this time, the delivery sheath 15 No force is exerted on the contracted left atrial appendage occluder, but the occluder cannot be deployed under the constraints of the left atrial appendage orifice; continue to withdraw the guide wire 16 to completely withdraw the occluder net 9 from the left atrial appendage, and the occluder net 9 and The second blocking membrane 3 expands under the action of its own elasticity. At the same time, the stent component 2 loses the restraint of the blocking net 9 and opens completely. The six outer stent wires 6 pull the first blocking membrane 1 to expand toward the inner wall of the left atrial appendage. At the same time, they give the inner stent wire 4 a pulling force to expand, assisting the stent wire 8 to expand. Support the outer stent wire 6; the inner stent wire 4 is stretched to all sides under its own elasticity, and the outer stent wire 6 and the edge of the first sealing membrane 1 are closely attached to the inner wall of the left atrial appendage, and at the same time, the direction of the left atrial appendage sealing device is applied. The internal tension of the left atrial appendage causes the blocking net 9 to closely fit on one side of the atrium to block the left atrial appendage opening; the guide wire 16 is rotated to separate the guide wire 16 from the outer stent base 7 to complete the placement of the left atrial appendage blocking device. It should be explained here that the delivery sheath 15 and the guide wire 16 are common methods used by those skilled in the art, and will not be described again here.

本发明的左心耳封堵器,能够从左心耳内部给左心耳封堵器拉力,拉力作用在封堵网9上,使其在左心房一侧紧密贴合覆盖左心耳口,本发明的抓钩单元200固定在人体左心耳内的特殊形态的梳状肌上,使得左心耳封堵器进行更稳定的固定,防止左心耳封堵器发生渗漏或脱落的情况;还能够针对特殊形态的梳状肌的个体差异,替换不同的抓钩单元200,增强左心耳封堵器贴合效果,封堵更紧密。The left atrial appendage occluder of the present invention can pull the left atrial appendage occluder from the inside of the left atrial appendage, and the pulling force acts on the occluder net 9 so that it can closely fit and cover the left atrial appendage orifice on the left atrium side. The hook unit 200 is fixed on the special-shaped pectinate muscle in the left atrial appendage of the human body, so that the left atrial appendage occluder can be fixed more stably and prevent the left atrial appendage occluder from leaking or falling off; it can also target special-shaped patients. Due to individual differences in pectinate muscles, different grapple units 200 can be replaced to enhance the fitting effect of the left atrial appendage occluder and achieve tighter occludement.

名词解释:Glossary:

特殊形态的梳状肌:在人体左心耳的内壁上具有梳状肌,在部分人体的左心耳内,存在梳状肌两端与左心耳内壁相连、中部不与左心耳内壁相连的情况,将这种中部没有与左心耳内壁相连的梳状肌称为特殊形态的梳状肌,特殊形态的梳状肌中部与左心耳内壁之间具有间隙。Special shape of pectinate muscle: There is a pectinate muscle on the inner wall of the left atrial appendage of the human body. In the left atrial appendage of some people, the two ends of the pectinate muscle are connected to the inner wall of the left atrial appendage, but the middle part is not connected to the inner wall of the left atrial appendage. This will This kind of pectinate muscle whose middle part is not connected to the inner wall of the left atrial appendage is called a pectinate muscle with a special shape. There is a gap between the middle part of the pectinate muscle with a special shape and the inner wall of the left atrial appendage.

本发明中应用了具体个例对本发明的原理及实施方式进行了阐述,以上实施例的说明只是用于帮助理解本发明的方法及其核心思想;同时,对于本领域的一般技术人员,依据本发明的思想,在具体实施方式及应用范围上均会有改变之处。综上所述,本说明书内容不应理解为对本发明的限制。Specific examples are used in the present invention to illustrate the principles and implementation methods of the present invention. The description of the above embodiments is only used to help understand the method of the present invention and its core idea; at the same time, for those of ordinary skill in the art, based on this The idea of the invention will be subject to change in the specific implementation and scope of application. In summary, the contents of this description should not be construed as limitations of the present invention.

Claims (7)

1.一种左心耳封堵器,其特征在于,包括:1. A left atrial appendage occlusion device, characterized by comprising: 封堵单元,所述封堵单元能够收缩和展开,且所述封堵单元展开时能够封堵人体左心耳;A blocking unit, the blocking unit can be contracted and expanded, and when expanded, the blocking unit can block the left atrial appendage of the human body; 抓钩单元,所述抓钩单元与所述封堵单元可拆卸连接,且所述抓钩单元能够固定在人体左心耳内的特殊形态的梳状肌上;A grapple unit, the grapple unit is detachably connected to the blocking unit, and the grapple unit can be fixed on the special-shaped pectinate muscle in the left atrial appendage of the human body; 所述封堵单元包括第一封堵膜、支架组件和第二封堵膜,所述第一封堵膜利用所述支架组件与所述第二封堵膜相连,所述第一封堵膜、所述支架组件以及所述第二封堵膜均由弹性材质制成,在自由状态下,所述第一封堵膜和所述第二封堵膜均为碗状结构,且二者的开口均朝向远离所述支架组件的方向设置;The blocking unit includes a first blocking membrane, a stent assembly and a second blocking membrane. The first blocking membrane is connected to the second blocking membrane using the stent assembly. The first blocking membrane , the stent assembly and the second blocking film are made of elastic material, in the free state, the first blocking film and the second blocking film are bowl-shaped structures, and both The openings are all arranged in a direction away from the bracket assembly; 所述支架组件包括内支架丝、内支架底座、外支架丝以及外支架底座,所述内支架底座位于所述第一封堵膜的收口端且二者相连,所述内支架丝的一端与所述第一封堵膜的开口端相连,另一端与所述内支架底座相连;所述外支架底座位于所述第二封堵膜的收口端且二者相连,所述外支架丝连接所述第一封堵膜与所述外支架底座。The stent assembly includes an inner stent wire, an inner stent base, an outer stent wire and an outer stent base. The inner stent base is located at the closing end of the first blocking film and is connected to each other. One end of the inner stent wire is connected to The opening end of the first blocking film is connected, and the other end is connected to the inner bracket base; the outer bracket base is located at the closing end of the second blocking membrane and the two are connected, and the outer bracket wire is connected to the The first sealing film and the outer bracket base. 2.根据权利要求1所述的左心耳封堵器,其特征在于:所述内支架丝和所述外支架丝的数量均为多根,所述内支架丝以及所述外支架丝绕所述第一封堵膜、所述第二封堵膜的轴线周向均布。2. The left atrial appendage occluder according to claim 1, characterized in that: the number of the inner stent wire and the outer stent wire is multiple, and the inner stent wire and the outer stent wire are wound around The axes of the first blocking film and the second blocking film are evenly distributed in the circumferential direction. 3.根据权利要求1所述的左心耳封堵器,其特征在于:所述内支架丝的形状与所述第一封堵膜的外形轮廓相一致;所述外支架丝还连接有辅助支架丝,所述辅助支架丝设置于相邻的两根所述外支架丝之间,所述辅助支架丝为X形。3. The left atrial appendage occlusion device according to claim 1, characterized in that: the shape of the inner stent wire is consistent with the outline of the first blocking membrane; the outer stent wire is also connected to an auxiliary stent. The auxiliary stent wire is arranged between two adjacent outer stent wires, and the auxiliary stent wire is X-shaped. 4.根据权利要求1所述的左心耳封堵器,其特征在于:所述封堵单元还包括封堵网,所述封堵网罩设于所述第二封堵膜的外部,所述封堵网的形状与所述第二封堵膜匹配,所述封堵网的收口端与所述外支架底座相连,所述封堵网由镍钛合金丝编织制成。4. The left atrial appendage occlusion device according to claim 1, characterized in that: the occlusion unit further includes a occlusion net, and the occlusion net cover is located outside the second occlusion membrane, and the The shape of the blocking net matches the second blocking film. The closing end of the blocking net is connected to the base of the outer bracket. The blocking net is made of woven nickel-titanium alloy wire. 5.根据权利要求1-4任一项所述的左心耳封堵器,其特征在于:所述内支架底座以及所述外支架底座均能够与输送鞘的导丝可拆装连接。5. The left atrial appendage occluder according to any one of claims 1 to 4, characterized in that: both the inner stent base and the outer stent base can be detachably connected to the guide wire of the delivery sheath. 6.根据权利要求1-4任一项所述的左心耳封堵器,其特征在于:所述抓钩单元包括依次相连的抓钩底座、弹簧、抓杆以及钩环,所述抓钩底座与所述封堵单元可拆卸连接,所述钩环能够钩挂在人体左心耳内的特殊形态的梳状肌上并实现固定。6. The left atrial appendage occluder according to any one of claims 1 to 4, characterized in that: the grapple unit includes a grapple base, a spring, a grapple rod and a shackle connected in sequence, and the grapple base Detachably connected to the blocking unit, the hook can be hooked on the special-shaped pectinate muscle in the left atrial appendage of the human body and fixed. 7.根据权利要求6所述的左心耳封堵器,其特征在于:所述钩环为具有缺口的环状结构,所述钩环的数量为多个,多个所述钩环绕所述抓杆的轴线周向均布。7. The left atrial appendage occluder according to claim 6, characterized in that: the shackle is an annular structure with a gap, the number of the shackles is multiple, and the plurality of hooks surround the grasping device. The axis of the rod is uniformly distributed around the circumference.
CN202310855093.5A 2023-07-13 2023-07-13 Left auricle occluder and placement method Active CN116570338B (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN202310855093.5A CN116570338B (en) 2023-07-13 2023-07-13 Left auricle occluder and placement method

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CN202310855093.5A CN116570338B (en) 2023-07-13 2023-07-13 Left auricle occluder and placement method

Publications (2)

Publication Number Publication Date
CN116570338A CN116570338A (en) 2023-08-11
CN116570338B true CN116570338B (en) 2023-10-10

Family

ID=87538202

Family Applications (1)

Application Number Title Priority Date Filing Date
CN202310855093.5A Active CN116570338B (en) 2023-07-13 2023-07-13 Left auricle occluder and placement method

Country Status (1)

Country Link
CN (1) CN116570338B (en)

Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN105434082A (en) * 2014-09-16 2016-03-30 徐州亚太科技有限公司 Left auricle plugging device
WO2016049991A1 (en) * 2014-09-29 2016-04-07 上海形状记忆合金材料有限公司 Left atrial appendage occlusion apparatus
WO2018219151A1 (en) * 2017-06-02 2018-12-06 上海微创医疗器械(集团)有限公司 Medical apparatus
CN208693357U (en) * 2017-08-21 2019-04-05 上海普实医疗器械科技有限公司 Occluder for left auricle
CN210354775U (en) * 2019-05-08 2020-04-21 广东脉搏医疗科技有限公司 Plug disc type left auricle occluder
CN112155627A (en) * 2020-07-28 2021-01-01 宁波迪创医疗科技有限公司 Left auricle occluder with bionic micro-thorn attachment structure
CN212879439U (en) * 2020-07-28 2021-04-06 宁波迪创医疗科技有限公司 A left atrial appendage occluder with a bionic micro-thorn attachment structure
CN113116407A (en) * 2019-12-31 2021-07-16 先健科技(深圳)有限公司 Plugging device

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN105434082A (en) * 2014-09-16 2016-03-30 徐州亚太科技有限公司 Left auricle plugging device
WO2016049991A1 (en) * 2014-09-29 2016-04-07 上海形状记忆合金材料有限公司 Left atrial appendage occlusion apparatus
WO2018219151A1 (en) * 2017-06-02 2018-12-06 上海微创医疗器械(集团)有限公司 Medical apparatus
CN208693357U (en) * 2017-08-21 2019-04-05 上海普实医疗器械科技有限公司 Occluder for left auricle
CN210354775U (en) * 2019-05-08 2020-04-21 广东脉搏医疗科技有限公司 Plug disc type left auricle occluder
CN113116407A (en) * 2019-12-31 2021-07-16 先健科技(深圳)有限公司 Plugging device
CN112155627A (en) * 2020-07-28 2021-01-01 宁波迪创医疗科技有限公司 Left auricle occluder with bionic micro-thorn attachment structure
CN212879439U (en) * 2020-07-28 2021-04-06 宁波迪创医疗科技有限公司 A left atrial appendage occluder with a bionic micro-thorn attachment structure

Also Published As

Publication number Publication date
CN116570338A (en) 2023-08-11

Similar Documents

Publication Publication Date Title
US10143458B2 (en) Intracardiac cage and method of delivering same
US9314249B2 (en) System and method for delivering a left atrial appendage containment device
US8764793B2 (en) Left atrial appendage occluder
US9717488B2 (en) Devices and systems for inverting and closing the left atrial appendage
US20090099596A1 (en) Closure device for left atrial appendage
US7479155B2 (en) Defect occluder release assembly and method
US20160095603A1 (en) Device for preventing clot migraton from left atrial appendage
CN101351242A (en) Method and instrument for filtrating embolus
CN106344100A (en) Left auricle plugging device
CN108472031B (en) Left auricle plugging device
US7806846B2 (en) Restoration of flow in LAA via tubular conduit
CN116570338B (en) Left auricle occluder and placement method
CN113057708A (en) A left atrial appendage occlusion device
CN115517735B (en) Plugging device
CN215306341U (en) Left auricle plugging device
CN113974716B (en) Plugging device
CN115252033A (en) Air bag suction type left auricle stabilizing and ligating system
CN209996397U (en) Left auricle plugging device
CN110613492B (en) Left auricle plugging device
US20240423630A1 (en) Occlusion apparatus and methods
CN115813461A (en) Medical plugging device
WO2023124466A1 (en) Occlusion device
WO2025013096A1 (en) Left atrial appendage closure device and method

Legal Events

Date Code Title Description
PB01 Publication
PB01 Publication
SE01 Entry into force of request for substantive examination
SE01 Entry into force of request for substantive examination
GR01 Patent grant
GR01 Patent grant