WO2018166378A1 - 一种左心耳封堵器 - Google Patents

一种左心耳封堵器 Download PDF

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Publication number
WO2018166378A1
WO2018166378A1 PCT/CN2018/078148 CN2018078148W WO2018166378A1 WO 2018166378 A1 WO2018166378 A1 WO 2018166378A1 CN 2018078148 W CN2018078148 W CN 2018078148W WO 2018166378 A1 WO2018166378 A1 WO 2018166378A1
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bracket
left atrial
atrial appendage
stent
rear end
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PCT/CN2018/078148
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English (en)
French (fr)
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刘云奇
殷胜利
郭少成
余聪阈
杨习锋
曾晨光
张希
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广州新诚生物科技有限公司
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Publication of WO2018166378A1 publication Critical patent/WO2018166378A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • 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

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  • the utility model belongs to the field of cardiac medical instruments, in particular to a left atrial appendage occluder.
  • Atrial fibrillation is the most common type of arrhythmia in the clinic.
  • the total incidence rate is as high as 0.77%. With the increase of age, the incidence rate is increasing, and the population over 75 years old can reach 10%.
  • the main hazard of atrial fibrillation is the left atrial thrombosis, which induces acute myocardial infarction stroke, peripheral vascular embolization and other complications, and increases disability and mortality.
  • more than 90% of the thrombus in patients with non-valvular atrial fibrillation comes from the left atrial appendage, so closing or sealing the left atrial appendage can significantly reduce thrombosis and reduce thromboembolic complications.
  • the minimally invasive left atrial appendage occlusion that has arisen in recent years avoids the shortcomings of the above-mentioned extracorporeal circulation surgery.
  • the purpose of the utility model is to overcome the deficiencies of the prior art, and to provide a left atrial appendage occluder, which ensures the firm fixation of the occluder in the left atrial appendage and effectively prevents the leakage of the thrombus.
  • a left atrial appendage occluder includes a front end of the bracket, a rear end of the bracket, a support frame and a bracket film, and the front end of the bracket and the rear end of the bracket pass through the support frame Connecting, the bracket film covers the front end of the bracket and the rear end surface of the bracket; the front end of the bracket and the rear end of the bracket are compressively deformable, and the front end of the bracket and the rear end of the bracket are shaped, behind the front end of the bracket and behind the bracket There is an angle between the ends, and the angle ranges from 5° to 30°.
  • the front end of the bracket and the rear end of the bracket are mesh structures woven from a memory alloy.
  • the compressed front end of the bracket is a cylindrical net body structure
  • the compressed rear end of the bracket is a cone net structure
  • the stent film is a biofilm with a thickness of 0.25 to 0.35 mm.
  • the compressed occluder is delivered to the left atrial appendage by a delivery device, and the occluder begins to recover shape after entering the left atrial appendage, and the front end of the stent is restored in shape to a lantern-shaped structure, and the stent is After the shape is restored, the shape is an umbrella structure.
  • the lantern-shaped structure is a mesh structure that intersects each other, and the umbrella-shaped structure is a uniformly distributed semi-elliptical structure, and the number of the semi-elliptical structures is 30-40.
  • the longitudinal structure of the mushroom structure and the lantern-shaped structure is circular, and the maximum diameter of the longitudinal section of the mushroom structure is larger than the maximum diameter of the longitudinal section of the lantern-shaped structure.
  • the longitudinal cross-sectional diameter of the lantern-shaped structure first increases from the left atrial appendage to the left atrial appendage and then decreases.
  • the compressed occluder moves the adjustment position back and forth in the left atrial appendage.
  • the front end of the bracket after the restored shape is fixedly attached to the inner wall of the left atrial appendage, and the rear end of the bracket after the restored shape is fixed and closed at the left atrial appendage.
  • the utility model has the beneficial effects that the occluder of the utility model adopts a two-stage memory alloy bracket, and after the occluder is installed in the left atrial appendage, the front end of the stent and the rear end of the stent recover the shape and have an angle of 5°-30°.
  • the front end of the stent-shaped memory alloy With the extraction of the delivery sheath, the front end of the stent-shaped memory alloy recovers its shape and is fixedly attached to the inner wall of the left atrial appendage.
  • the umbrella-shaped memory alloy at the rear end of the stent recovers and is in close contact with the left atrial appendage, effectively preventing the occluder from continuing to enter the left.
  • Figure 1 is a schematic view showing the structure of the left atrial appendage occluder without the stent film
  • FIG. 2 is a schematic structural view of the left atrial appendage occluder covering the stent film according to the present invention
  • Figure 3 is a schematic view showing the structure of the left atrial appendage occlusion device in a compressed state before entering the left atrial appendage;
  • Figure 4 is a schematic view showing the structure of the front end of the stent after the left atrial appendage occlusion device enters the left atrial appendage;
  • Fig. 5 is a schematic view showing the structure of the memory alloy stent completely restored after the left atrial appendage occlusion device enters the left atrial appendage.
  • the left atrial appendage occluder 1 includes a stent front end 11 and a stent rear end 12, a support frame 13 and a stent film 14, and a stent front end 11 and
  • the bracket rear end 12 is coupled by a support frame 13 that covers the surface of the bracket front end 11 and the bracket rear end 12.
  • the front end 11 of the bracket and the rear end 12 of the bracket are mesh structures woven from a memory alloy, and the memory alloy bracket is compressible and deformable.
  • the left atrial appendage occluder 1 can be stretched and compressed along the axial direction.
  • the compressed stent front end 11 is a cylindrical mesh structure
  • the compressed stent rear end 12 is a cone mesh body. structure.
  • the compressed left atrial appendage occluder 1 is connected to the delivery device, and the left atrial appendage occluder 1 is delivered into the lumen of the left atrial appendage 2 through the delivery sheath. Both the front end of the stent and the rear end surface of the stent are covered with a stent film to prevent the leakage of blood vessels more effectively.
  • the stent film 14 is a biofilm with a thickness of 0.25-0.35 mm, and the stent film 14 covers the compressed stent front end 11 and the stent rear end 12 surface, and the compressed left atrial appendage occlusion device 1 enters the left atrial appendage 2
  • the biofilm can expand with the recovery deformation of the front end 11 of the stent and the rear end 12 of the stent, so that it closely covers the surface of the memory alloy stent.
  • the front end 11 of the bracket is placed in the inner cavity of the left atrial appendage 2, and the restored shape of the front end 11 of the bracket is a lantern-shaped structure, and the lantern-shaped structure is a mesh structure that crosses each other.
  • the restored front end 11 of the bracket is fixed and closely attached thereto.
  • the inner wall of the left atrial appendage 2 has the effect of blocking the front end 11 of the stent to block the left atrial appendage 2; the rear end 12 of the stent is placed at the left atrial appendage 2, and the restored shape of the rear end 12 of the stent is an umbrella structure, and the umbrella structure is an evenly distributed half.
  • the number of elliptical structures and semi-elliptical structures is 30-40, and the rear end 12 of the stent after the restored shape is fixed and closed at the mouth of the left atrial appendage, effectively preventing the left atrial appendage occluder 1 from continuing into the lumen of the left atrial appendage 2 and falling off. . Since the surface of the stent film 14 has no barb structure, the installation position of the left atrial appendage occluder 1 can be appropriately adjusted during the installation of the left atrial appendage occluder 1, and the left atrial appendage can be adjusted to a suitable position in the left atrial appendage 2 of different configurations. The installation of the plug 1 reduces the complexity of the procedure.
  • the stent front end 11 and the stent rear end 12 have an angle of 5°-30° after the shape is completely restored, and the angle can be appropriately adjusted according to different configurations of the left atrial appendage 2, so that The left atrial appendage occluder 1 is tightly connected to the left atrial appendage 2 .
  • the longitudinal section of the rear end 12 of the mushroom-shaped structure bracket and the front end 11 of the lantern-shaped structure bracket are circular, and the longitudinal section diameter of the lantern-shaped structure is increased from the inner cavity of the left atrial appendage 2 to the left atrial appendage 2
  • the maximum diameter of the longitudinal section of the mushroom structure is smaller than the maximum diameter of the longitudinal section of the lantern structure.

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

Abstract

一种左心耳封堵器（1），包括支架前端（11）、支架后端（12）、支撑架（13）和支架薄膜（14），支架前端（11）和支架后端（12）通过支撑架（13）连接，支架薄膜（14）覆盖于支架前端（11）和支架后端（12）表面；支架前端（11）和支架后端（12）可压缩变形，左心耳封堵器（1）安装到左心耳（2）内，支架前端（11）和支架后端（12）恢复形状，支架前端（11）和支架后端（12）存在5°-30°夹角，支架前端（11）灯笼型记忆合金恢复形状并固定在左心耳（2）内壁上，随着输送鞘的抽出，支架后端（12）伞型记忆合金恢复形状与左心耳（2）口紧密接触，有效防止封堵器（1）继续进入左心耳（2）内腔及脱落；支架薄膜（14）可以更有效防止血栓子遗漏；由于支架薄膜（14）表面无倒钩结构，可以在不同构造的左心耳（2）中调整位置，降低手术的复杂性。

Description

一种左心耳封堵器 技术领域
本实用新型属于心脏医疗器械领域，具体涉及一种左心耳封堵器。
背景技术
心房颤动(房颤)是临床上最常见的心律失常类型，总发病率高达0.77％，随着年龄增长其发病率不断增加，75岁以上人群可达10％。房颤最主要的危害是导致左心房血栓形成，血栓脱落后诱发急性心肌梗死卒中、外周血管栓塞等并发症，增加致残率和致死率。目前非瓣膜性房颤患者中90％以上的血栓来自左心耳，所以闭合或封堵左心耳可明显减少血栓形成，降低血栓栓塞并发症。传统的治疗方案包括口服抗凝药物，房颤射频消融及左心耳结扎手术等，但口服抗凝药物服用贵，易导致出血并发症及患者长期服药依从性不佳等问题；房颤射频消融术创伤大，费用高，易复发；左心耳结扎需开胸手术，创伤大。以上治疗方案均存在不足。
近年来兴起的微创左心耳封堵术避免了上述体外循环手术的缺点。但因左心耳的解剖形态各异，及现有封堵器设计原理及结构上的缺陷，一方面易导致术中及术后出现血液残余，达不到理想的封堵效果；另一方面，由于封堵器固定不牢固，容易发生脱落现象，增加了术中或术后的复杂性。
实用新型内容
本实用新型的目的在于克服现有技术的不足，提供了一种左心耳封堵器，确保封堵器在左心耳内的牢固固定，并且有效防止血栓子遗漏。
为达到上述目的，本实用新型采用的技术方案如下：一种左心耳封堵器，包括记支架前端、支架后端、支撑架和支架薄膜，所述支架前端和所述支架后端通过支撑架连接，所述支架薄膜覆盖于所述支架前端和支架后端表面；所述支架前端和支架后端可压缩变形，所述支架前端和支架后端复形状后，在所述支架前端和支架后端之间存在夹角，所述夹角的范围为5°-30°。
优选的，所述支架前端和支架后端是由记忆合金编织成的网状结构。
优选的，压缩后的所述支架前端为筒状网体结构，压缩后的所述支架后端为锥筒网体结构。
优选的，所述支架薄膜为生物膜，厚度为0.25～0.35mm。
优选的，压缩后的所述封堵器通过输送装置输送到左心耳内腔，所述封堵器进入左心耳后开始恢复形状，所述支架前端恢复形状后为灯笼形结构，所述支架后端恢复形状后为伞形结构。
优选的，所述灯笼形结构为相互交叉的网状结构，所述伞形结构为均匀分布的半椭圆结构，所述半椭圆结构的数量为30～40个。
优选的，所述伞形结构和所述灯笼形结构的纵截面为圆形，所述伞形结构纵截面的最大直径大于所述灯笼形结构纵截面的最大直径。
优选的，所述灯笼形结构的纵截面直径从所述左心耳内腔至所述左心耳口先增大后减小。
优选的，压缩后的所述封堵器在所述左心耳内腔前后移动调整位置。
优选的，恢复形状后的所述支架前端固定紧贴在所述左心耳内壁上，恢复形状后的所述支架后端固定并封闭在所述左心耳口。
本实用新型的有益效果：本实用新型的封堵器采用的是两段记忆合金支架，封堵器安装到左心耳内后，支架前端和支架后端恢复形状后存在5°-30°夹角，随着输送鞘的抽出，支架前端灯笼型记忆合金恢复形状并固定紧贴在左心耳内壁上，支架后端伞型记忆合金恢复并与左心耳口紧密接触，有效防止封堵器继续进入左心耳内腔及脱落；由于支架前端和支架后端表面都覆盖有支架薄膜，可以更有效防止血栓遗漏；由于支架薄膜表面无倒钩结构，可以在封堵器安装过程中适当调整封堵器安装位置，在不同构造的左心耳中可以调整到合适位置进行安装，降低手术的复杂性。
附图说明
图1为本实用新型左心耳封堵器未覆有支架薄膜的结构示意图；
图2为本实用新型左心耳封堵器覆盖支架薄膜后的结构示意图；
图3为本实用新型左心耳封堵器进入左心耳前的压缩状态结构示意图；
图4为本实用新型左心耳封堵器进入左心耳后支架前端恢复形状的结构示意图；
图5为本实用新型左心耳封堵器进入左心耳后记忆合金支架完全恢复形状的结构示意 图。
具体实施方式
下面结合附图对本实用新型的具体实施方式作进一步说明：
为达到上述目的，本实用新型采用的技术方案如下：如图1和2所示，左心耳封堵器1包括支架前端11和支架后端12、支撑架13和支架薄膜14，支架前端11和支架后端12通过支撑架13连接，支架薄膜14覆盖于支架前端11和支架后端12的表面。支架前端11和支架后端12是由记忆合金编织成的网状结构，记忆合金支架可压缩变形。
如图3-5所示，左心耳封堵器1可以沿着轴向进行拉伸并压缩，压缩后的支架前端11为筒状网体结构，压缩后的支架后端12为锥筒网体结构。压缩后的左心耳封堵器1与输送装置连接，通过输送鞘将左心耳封堵器1送入左心耳2内腔中。支架前端和支架后端表面都覆盖有支架薄膜，可以更有效防止血栓子遗漏。
在本实用新型中支架薄膜14为生物膜，厚度为0.25～0.35mm，支架薄膜14覆盖在压缩后的支架前端11和支架后端12表面，压缩后的左心耳封堵器1进入左心耳2内腔后开始逐渐恢复性状，生物膜可以随着支架前端11和支架后端12的恢复变形而扩张，使其紧密覆盖在记忆合金支架表面。
支架前端11置于左心耳2的内腔中，支架前端11的恢复形状后为灯笼形结构，灯笼形结构为相互交叉的网状结构，恢复形状后的支架前端11固定并紧贴在所述左心耳2内壁上，使支架前端11封堵左心耳2的效果；支架后端12置于左心耳2口，支架后端12的恢复形状后为伞形结构，伞形结构为均匀分布的半椭圆结构，半椭圆结构的数量为30～40个，恢复形状后的支架后端12固定并封闭在所述左心耳2口，有效防止左心耳封堵器1继续进入左心耳2内腔及脱落。由于支架薄膜14表面无倒钩结构，可以在左心耳封堵器1安装过程中适当调整左心耳封堵器1的安装位置，在不同构造的左心耳2中可以调整到合适位置进行左心耳封堵器1的安装，降低手术的复杂性。
左心耳封堵器1安装到左心耳2内后，支架前端11和支架后端12完全恢复形状后存在5°-30°夹角，夹角可以根据不同构造的左心耳2进行适当调节，使左心耳封堵器1与左心耳2紧密连接固定。
恢复形状后的伞形结构支架后端12和灯笼形结构支架前端11的纵截面为圆形，灯笼形结构的纵截面直径从所述左心耳2内腔至所述左心耳2口先增大后减小，伞形结构纵截 面的最大直径大于灯笼形结构纵截面的最大直径。
根据上述说明书的揭示和教导，本实用新型所属领域的技术人员还可以对上述实施方式进行变更和修改。因此，本实用新型并不局限于上面揭示和描述的具体实施方式，对实用新型的一些修改和变更也应当落入本实用新型的权利要求的保护范围内。此外，尽管本说明书中使用了一些特定的术语，但这些术语只是为了方便说明，并不对本实用新型构成任何限制。

Claims (10)

  1. 一种左心耳封堵器，包括记支架前端、支架后端、支撑架和支架薄膜，其特征在于，所述支架前端和所述支架后端通过支撑架连接，所述支架薄膜覆盖于所述支架前端和支架后端表面；所述支架前端和支架后端可压缩变形，所述支架前端和支架后端复形状后，在所述支架前端和支架后端之间存在夹角，所述夹角的范围为5°-30°。
  2. 根据权利要求1所述的一种左心耳封堵器，其特征在于，所述支架前端和支架后端是由记忆合金编织成的网状结构。
  3. 根据权利要求1所述的一种左心耳封堵器，其特征在于，压缩后的所述支架前端为筒状网体结构，压缩后的所述支架后端为锥筒网体结构。
  4. 根据权利要求1所述的一种左心耳封堵器，其特征在于，所述支架薄膜为生物膜，厚度为0.25～0.35mm。
  5. 根据权利要求1所述的一种左心耳封堵器，其特征在于，压缩后的所述封堵器通过输送装置输送到左心耳内腔，所述封堵器进入左心耳后开始恢复形状，所述支架前端恢复形状后为灯笼形结构，所述支架后端恢复形状后为伞形结构。
  6. 根据权利要求5所述的一种左心耳封堵器，其特征在于，所述灯笼形结构为相互交叉的网状结构，所述伞形结构为均匀分布的半椭圆结构，所述半椭圆结构的数量为30～40个。
  7. 根据权利要求5所述的一种左心耳封堵器，其特征在于，所述伞形结构和所述灯笼形结构的纵截面为圆形，所述伞形结构纵截面的最大直径大于所述灯笼形结构纵截面的最大直径。
  8. 根据权利要求5所述的一种左心耳封堵器，其特征在于，所述灯笼形结构的纵截面直径从所述左心耳内腔至所述左心耳口先增大后减小。
  9. 根据权利要求4所述的一种左心耳封堵器，其特征在于，压缩后的所述封堵器在所述左心耳内腔前后移动调整位置。
  10. 根据权利要求5所述的一种左心耳封堵器，其特征在于，恢复形状后的所述支架前端固定紧贴在所述左心耳内壁上，恢复形状后的所述支架后端固定并封闭在所述左心耳口。
PCT/CN2018/078148 2017-03-17 2018-03-06 一种左心耳封堵器 WO2018166378A1 (zh)

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CN105615936A (zh) * 2014-11-22 2016-06-01 常州乐奥医疗科技有限公司 一种新型左心耳封堵器
WO2016155941A1 (de) * 2015-03-27 2016-10-06 Pfm Medical Ag VORRICHTUNG ZUM VERSCHLIEßEN EINES HERZOHRS
CN106344100A (zh) * 2016-10-11 2017-01-25 北京工业大学 左心耳封堵器

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Publication number Priority date Publication date Assignee Title
CN105615936A (zh) * 2014-11-22 2016-06-01 常州乐奥医疗科技有限公司 一种新型左心耳封堵器
WO2016155941A1 (de) * 2015-03-27 2016-10-06 Pfm Medical Ag VORRICHTUNG ZUM VERSCHLIEßEN EINES HERZOHRS
CN106344100A (zh) * 2016-10-11 2017-01-25 北京工业大学 左心耳封堵器

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