WO2017157071A1 - 一种通过推头端光缆进行半释放状态的心耳封堵器 - Google Patents

一种通过推头端光缆进行半释放状态的心耳封堵器 Download PDF

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Publication number
WO2017157071A1
WO2017157071A1 PCT/CN2016/110911 CN2016110911W WO2017157071A1 WO 2017157071 A1 WO2017157071 A1 WO 2017157071A1 CN 2016110911 W CN2016110911 W CN 2016110911W WO 2017157071 A1 WO2017157071 A1 WO 2017157071A1
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Prior art keywords
occluder
tail
control cable
end control
head
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PCT/CN2016/110911
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English (en)
French (fr)
Inventor
周庆亮
李金山
孟坚
可大年
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北京迈迪顶峰医疗科技有限公司
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Application filed by 北京迈迪顶峰医疗科技有限公司 filed Critical 北京迈迪顶峰医疗科技有限公司
Priority to RU2018134353A priority Critical patent/RU2700673C1/ru
Priority to US16/081,006 priority patent/US11213297B2/en
Priority to BR112018068467-8A priority patent/BR112018068467B1/pt
Priority to JP2018547298A priority patent/JP6632741B2/ja
Priority to EP16894230.8A priority patent/EP3431021A4/en
Publication of WO2017157071A1 publication Critical patent/WO2017157071A1/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
    • 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
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • 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
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/12168—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure
    • A61B17/12172—Occluding 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • 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
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12027—Type of occlusion
    • A61B17/12031—Type of occlusion complete occlusion
    • 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
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
    • A61B17/12109—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel
    • 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
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
    • A61B17/12122—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder within the heart
    • 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
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/12159—Solid plugs; being solid before insertion
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00477—Coupling
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831—Material properties
    • A61B2017/00867—Material properties shape memory effect
    • 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
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B2017/1205—Introduction devices
    • A61B2017/12054—Details concerning the detachment of the occluding device from the introduction device
    • 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
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B2017/1205—Introduction devices
    • A61B2017/12054—Details concerning the detachment of the occluding device from the introduction device
    • A61B2017/12095—Threaded connection

Definitions

  • Embodiments of the present invention relate to the field of medical devices, and in particular, to a cardio-occlusive occluder in a semi-release state by a push-end cable.
  • Atrial fibrillation is one of the most common arrhythmias in clinical practice. There are a large number of patients. At present, there are about 8 million patients with atrial fibrillation in China, and the number is increasing year by year. Atrial fibrillation patients have a stroke of 0.4%-1% every year. That is to say, in the 8 million patient population, between 3.2 and 80,000 people may have an ischemic stroke due to atrial fibrillation. Stroke is the greatest risk of atrial fibrillation. The study found that 15-20% of ischemic strokes are caused by atrial fibrillation, and about one in every six stroke patients is atrial fibrillation.
  • the first method is to take anticoagulant drugs, such as warfarin, but the application of warfarin has a certain risk of bleeding, and it requires frequent monitoring, contraindications, clinical application is more difficult; in addition, warfarin also causes bone The possibility of loose and soft tissue necrosis.
  • the second method is the direct resection or ligation of the auricle in the same period of cardiac surgery.
  • the main disadvantage of this method is the low rate of complete closure of the left atrial appendage. Previous studies have shown that the success rate of complete resection of the left atrial appendage is up to about 80%; The risk of cracking and bleeding.
  • the third method is to close the left atrial appendage by the instrument and percutaneously intervene in the left atrial appendage to block products such as PLAATO, WATCHMAN, ACP, etc.
  • An occluder to block the left atrial appendage can reduce the incidence of stroke in patients with atrial fibrillation.
  • the principle of action is: the left atrial appendage occlusion device closes the left atrial entrance of the left atrial appendage, blocks the blood flow of the left atrial appendage and the left atrium, prevents the thrombus generated by the left atrial appendage from entering the atrium, and reduces the risk of stroke. After a period of time, the surface of the occluder is endothelialized, which can completely solve the problem of the left atrial appendage thrombus entering the left atrium.
  • the intervention of the left atrial appendage is a hot spot at home and abroad.
  • the shape of the left atrial appendage is different and irregular, the matching of the occluder and the auricle will have certain difficulties; the current auricular occluder has the following disadvantages:
  • the existing auricular occluder is a one-step release, which is not pre-adjustable. Only when the occluder is completely released can it be determined whether it is released in place. If the position is improper, it can only be fully retracted, released again, and the previous release process is repeated. The accuracy of positioning is poor.
  • the technical problem to be solved by the embodiments of the present invention is how to adjust the position of the occluder in the auricle, so that the occluder can be accurately released in the expected position, the difficulty of the operation is reduced, and the success rate of the operation is improved.
  • an embodiment of the present invention provides a heart-ear occluder in a semi-release state by a push-end optical cable, which includes an occluder body, a head end control optical cable, and a tail end control optical cable, and the occluder
  • the head end of the body is connected to one end of the head end control cable through a head end threaded sleeve
  • the tail end of the occluder body is connected to one end of the tail end control cable through a tail end thread sleeve, the tail end control
  • the optical cable has a hollow column shape, and the other end of the head end control cable sequentially passes through the tail end thread sleeve and the The tail end control cable;
  • the occluder body is a woven mesh support structure having a preset shape that is matched with the auricle structure after complete release, and the occluder body is strip-shaped on the outer sheath before being released In the tube, the occluder body is in a semi-release
  • the outer diameter of the head end control cable is smaller than the inner diameter of the tail thread sleeve and the tail end control cable.
  • the head end thread sleeve and the tail end thread sleeve are nuts.
  • the outer surface of the occluder body is a nickel-titanium wire woven mesh.
  • the occluder body is woven from a plurality of layers of nickel-titanium wire woven mesh.
  • the occluder body is woven from a single layer of nickel-titanium wire woven mesh, and the inner slit is provided with a film.
  • the film is a PET or ePTFE film.
  • head end thread sleeve and the tail end thread sleeve are respectively weldedly connected to the occluder body.
  • the embodiment of the invention has the following advantages:
  • the embodiment of the invention provides a cardio-occupant occlusion device in a semi-release state by a push-end cable, wherein a head end of the occluder body is connected with one end of a head-end control cable, and a tail end of the occluder body is One end of the tail end control cable is connected, the other end of the head end control cable passes through the other end of the tail end control cable, and the occluder body is placed in a semi-release state after being pushed out of the outer sheath tube for adjustment
  • the occluder body leaves room for the position in the auricle, adjusts the size of the occluder body by pushing the head end control cable, and adjusts the position of the occluder body in the auricle by moving the tail end control cable to ensure the position After the occluder body is completely released, it can be accurately released in the expected auricle sealing position, which reduces the difficulty of the operation and improves the success rate of the operation;
  • the auricle occlusion device in the semi-release state by the push-end cable is designed according to the anatomical structure of the left atrial appendage, which can perfectly match the atrial appendage structure, achieve the ideal sealing effect, and effectively prevent the movement of the instrument. Position and shedding reduce the difficulty of operation, reduce the number of repeated releases, and reduce the probability of adverse events.
  • FIG. 1 is an overall longitudinal cross-sectional view showing a semi-release state of an auricle occluder in a semi-release state by a push-end cable according to an embodiment of the present invention
  • FIG. 2 is a schematic view showing the overall structure of a presbyopic occluder in a semi-release state by a push-end cable according to an embodiment of the present invention
  • FIG. 3 is a schematic structural view of a presbyopic occluder in a semi-release state in a semi-release state in a semi-release state according to an embodiment of the present invention
  • FIG. 4 is a schematic structural view of a cardio-occlusive occluder in a semi-release state after being completely released by a push-end optical cable according to an embodiment of the present invention
  • FIG. 5 is a schematic structural view showing the complete release of the auricular occluder in a semi-release state by a push-end cable in the auricle according to an embodiment of the present invention.
  • 1 occluder body
  • 2 head end control cable
  • 3 tail end control cable
  • 4 head end threaded sleeve
  • 5 tail end threaded sleeve
  • 6 outer sheath tube
  • 7 auricle.
  • the terms “installation”, “connected”, and “connected” are to be understood broadly, and may be, for example, a fixed connection or a Removable connection, or integral connection; may be mechanical connection or electrical connection; may be directly connected, or may be indirectly connected through an intermediate medium, and may be internal communication between the two elements.
  • the specific meanings of the above terms in the embodiments of the present invention can be understood in a specific case for those skilled in the art.
  • an auricle occluder in a semi-release state by a push-end cable is provided in the embodiment of the present invention, which includes an occluder body 1, a head end control cable 2, and a tail end control.
  • the fiber optic cable 3, the head end of the occluder body 1 is connected to one end of the head end control cable 2 through a head end threaded sleeve 4, specifically, one end of the tail end control cable 3 is provided with an external thread.
  • the head end threaded sleeve 4 is internally threaded, and the tail end control cable 3 is screwed to the head end threaded sleeve 4, so that the two can be unfixed by means of a spiral, the occluder
  • the tail end of the body 1 is connected to one end of the tail end control cable 3 through a tail end threaded sleeve 5, the tail end control cable 3 has a hollow column shape, and the other end of the head end control cable 2 passes through the tail sequentially.
  • the end threaded sleeve 5 and the tail end control cable 3, and the head end of the occluder body 1 is located above the tail end of the occluder body 1;
  • the body 1 is in the form of a woven mesh support having a predetermined shape that is matched with the structure of the auricle 7 after complete release.
  • the occluder body 1 is stretched and stripped in the outer sheath tube 6 before release.
  • the size of the auricle occluder in a semi-release state by the push end cable is minimized, and the outer diameter of the head end sleeve 4 and the end thread sleeve 5 are preferably set to be the same, and is also conveniently installed in the outer sheath tube 6.
  • the occluder body 1 is in a semi-release state after the outer sheath tube 6 is pushed out, so as to be able to adjust the position of the occluder body 1 in the auricle 7, since the occluder body 1 is in a semi-release state, It does not completely fit the inner wall of the auricle 7 (as shown in FIG.
  • the diameter of the occluder body 1 can be changed by pushing the head end control cable 2 to change the occluder body 1
  • the size of the occluder body 1 can be adjusted by moving the tail end control cable 3, and the two control cables can be independently operated without affecting each other to achieve accurate occluder body 1 Ground completely released in the expected auricular 7 blocked position Reducing the difficulty of surgery and improve the success rate of surgery.
  • the outer diameter of the head end control cable 2 is smaller than the inner diameters of the tail end thread sleeve 5 and the tail end control cable 3, so that the head end control cable 2 can be screwed at the end end of the sleeve 5 and the tail end.
  • the end controls the movement inside the optical cable 3.
  • the head end threaded sleeve 4 and the tail end threaded sleeve 5 may be nuts, and the head end threaded sleeve 4 and the tail end threaded sleeve 5 may respectively be welded to the head of the occluder body 1 The ends and the ends form a closed whole.
  • the outer surface of the occluder body 1 is a nickel-titanium wire woven mesh, and the nickel-titanium alloy woven mesh is fixed into a predetermined shape by a heat treatment process to constitute the occluder body 1.
  • the occluder body 1 is preferably woven from a plurality of layers of nickel-titanium woven mesh to prevent blood exchange between the atrium and the atrial appendage 7.
  • the occluder body 1 can also be woven from a single layer of nickel-titanium wire woven mesh, in order to improve
  • the blood-blocking property may be provided with a film in a single-layer nickel-titanium wire woven mesh, and the film is preferably PET (polyethylene terephthalate) or ePTFE film (formed by polytetrafluoroethylene as a raw material by expansion stretching) Microporous membrane).
  • the occluder body 1 may be in a cylindrical shape or a large truncated cone shape when fully released, and placed in the opening of the left atrial appendage 7 through the occluder body 1. Supporting force, the occluder body 1 and the inner wall of the auricle 7 are completely fitted together (as shown in FIG. 5), and the auricle occluder in the semi-release state through the pusher end cable is prevented from being displaced and detached by frictional force, of course, It can also be in other suitable shapes after the occluder body 1 is completely released.
  • the embodiment of the present invention can adjust the position of the occluder in the auricle 7 so that the occluder can be accurately released in the expected position, the difficulty of the operation is reduced, and the success rate of the operation is improved;
  • the auricle occlusion device in the semi-release state by the push-end cable is designed according to the anatomical structure of the inner cavity of the left atrial appendage 7, and can perfectly match the structure of the auricle 7 to achieve an ideal sealing effect and effectively prevent the device. Displacement, shedding; and reduce the difficulty of operation, reduce the number of repeated release, reducing the probability of adverse events.

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Abstract

一种通过推头端光缆进行半释放的心耳封堵器，包括封堵器本体(1)、头端控制光缆(2)和尾端控制光缆(3)，封堵器本体(1)的头端通过头端螺纹套(4)与头端控制光缆(2)的一端连接，封堵器本体(1)的尾端通过尾端螺纹套(5)与尾端控制光缆(3)的一端连接，尾端控制光缆(3)呈空心柱状，头端控制光缆(2)的另一端依次穿过尾端螺纹套(5)和尾端控制光缆(3)，封堵器本体(1)呈编织的网状支架结构，其具有预设的完全释放后与心耳结构匹配的外形，封堵器本体(1)释放前呈条状设于外鞘管(6)内，封堵器本体(1)推出外鞘管(6)后处于半释放状态，通过推拉头端控制光缆(2,3)改变封堵器本体(1)的直径。该心耳封堵器能够调整封堵器在心耳中的位置，使封堵器能够准确的释放在预期的位置。

Description

一种通过推头端光缆进行半释放状态的心耳封堵器 技术领域
本发明实施例涉及医疗器械领域，特别是涉及一种通过推头端光缆进行半释放状态的心耳封堵器。
背景技术
房颤是临床上最为常见的心律失常之一，患病人数众多，目前我国约有800万房颤患者，且数量逐年增加，房颤患者每年有0.4％-1％的人发生脑卒中，也就是说在800万患病人群中，每年有3.2-8万的人可能因为房颤产生缺血性脑卒中。脑卒中是房颤最大的危害，研究发现15～20％的缺血性脑卒中由房颤引起，约每6例脑卒中患者中有1个是房颤患者。非瓣膜病性房颤病人脑卒中发生率是正常人的5.6倍，瓣膜病房颤脑卒中发生率是正常人的17.6倍；而且房颤引起的脑卒中后果更为严重，死亡率和致残率达到70％。对瓣膜性房颤的病人，57％的心房血栓来源于左心耳，对于非瓣膜房颤的病人，90％的左心房血栓来源于左心耳。即使恢复窦律后，左心耳收缩顿抑，仍有可能再形成血栓。
目前临床上预防房颤缺血性脑卒中的方法主要有三种。第一种方法是服用抗凝药物，如华法林，但应用华法林具有一定的出血风险，且须要频繁监测，禁忌症比较多，临床应用较为困难；另外华法林还有导致骨质疏松和软组织坏死的可能。第二种方法是心脏外科手术同期直接切除或结扎心耳，这种方法的主要不足是左心耳的完全闭合率较低，既往研究显示完全切除左心耳的成功率最高约80％；而且会有撕裂、出血的风险。第三种方法是通过器械闭合左心耳，经皮介入左心耳封堵产品，如PLAATO、WATCHMAN、ACP等。通过左心耳 封堵器来封堵左心耳，可以降低房颤病人中风的发生率。其作用原理是：左心耳封堵器封闭左心耳的左心房入口，阻断左心耳和左心房血流，防止左心耳产生的血栓进入到心房，降低中风发生的风险。经过一段时间后，封堵器表面内皮化，可以彻底解决左心耳血栓进入左心房的问题。
目前左心耳介入封堵是国内外研究的热点，市场上也有国外的封堵器械，而国内的相关器械也在研发之中。由于左心耳的形态各异，且不规则，封堵器和心耳的匹配会有一定的困难；而目前的心耳封堵器存在如下缺点：
(1)现有心耳封堵器都是一步释放，不可预调，只有封堵器完全释放后，才能确定是否释放到位，如果位置不当，只能完全收回后，再次释放，重复之前的释放过程，定位的准确度较差。
(2)目前心耳封堵器多数带有倒刺结构，可能的多次释放，会使心耳容易出现刺穿、撕裂等不良事件，对患者造成伤害。
发明内容
(一)要解决的技术问题
本发明实施例要解决的技术问题是如何调整封堵器在心耳中的位置，使封堵器能够准确的释放在预期的位置，降低手术的难度，提高手术成功率。
(二)技术方案
为了解决上述技术问题，本发明实施例提供一种通过推头端光缆进行半释放状态的心耳封堵器，其包括封堵器本体、头端控制光缆和尾端控制光缆，所述封堵器本体的头端通过头端螺纹套与所述头端控制光缆的一端连接，所述封堵器本体的尾端通过尾端螺纹套与所述尾端控制光缆的一端连接，所述尾端控制光缆呈空心柱状，所述头端控制光缆的另一端依次穿过所述尾端螺纹套和所 述尾端控制光缆；所述封堵器本体呈编织的网状支架结构，其具有预设的完全释放后与心耳结构匹配的外形，所述封堵器本体释放前呈条状设于外鞘管内，所述封堵器本体推出所述外鞘管后处于半释放状态，以能够调整所述封堵器本体在心耳内的位置，通过推拉头端控制光缆改变所述封堵器本体的直径，以实现将所述封堵器本体完全释放在预期的封堵位置。
其中，所述头端控制光缆的外径小于所述尾端螺纹套和尾端控制光缆的内径。
其中，所述头端螺纹套与所述尾端螺纹套为螺母。
其中，所述封堵器本体的外表面为镍钛丝编织网。
其中，所述封堵器本体由多层镍钛丝编织网编织而成。
其中，所述封堵器本体由单层镍钛丝编织网编织而成，其内缝设有薄膜。
其中，所述薄膜为PET或ePTFE膜。
其中，所述头端螺纹套和所述尾端螺纹套分别与所述封堵器本体焊接连接。
(三)有益效果
与现有技术相比，本发明实施例具有以下优点：
本发明实施例提供的一种通过推头端光缆进行半释放状态的心耳封堵器，采用封堵器本体的头端与头端控制光缆的一端连接，所述封堵器本体的尾端与尾端控制光缆的一端连接，所述头端控制光缆的另一端穿过所述尾端控制光缆的另一端，并设置所述封堵器本体推出外鞘管后处于半释放状态，以给调整所述封堵器本体在心耳内的位置留出余地，通过推拉头端控制光缆调节封堵器本体的大小，通过移动尾端控制光缆调整封堵器本体在心耳内的位置，以保证所 述封堵器本体完全释放后能够准确地释放在预期的心耳封堵位置，降低了手术的难度，提高了手术成功率；
本发明实施例的通过推头端光缆进行半释放状态的心耳封堵器根据左心耳内腔的解剖结构进行设计，能够与心耳结构完美匹配，达到理想的封堵效果，同时有效防止器械的移位、脱落，降低了操作的难度，减少了重复释放的次数，减少了不良事件发生的概率。
附图说明
图1为本发明实施例一种通过推头端光缆进行半释放状态的心耳封堵器处于半释放状态的整体纵向剖视图；
图2为本发明实施例一种通过推头端光缆进行半释放状态的心耳封堵器处于半释放状态的整体结构示意图；
图3为本发明实施例一种通过推头端光缆进行半释放状态的心耳封堵器在心耳中处于半释放状态的结构示意图；
图4为本发明实施例一种通过推头端光缆进行半释放状态的心耳封堵器完全释放后的结构示意图；
图5为本发明实施例一种通过推头端光缆进行半释放状态的心耳封堵器完全释放在心耳中的结构示意图。
图中：1：封堵器本体；2：头端控制光缆；3：尾端控制光缆；4：头端螺纹套；5：尾端螺纹套；6：外鞘管；7：心耳。
具体实施方式
下面结合附图和实施例，对本发明实施例的具体实施方式作进一步详细描 述。以下实例用于说明本发明实施例，但不用来限制本发明实施例的范围。
在本发明实施例的描述中，需要说明的是，术语“中心”、“纵向”、“横向”、“上”、“下”、“前”、“后”、“左”、“右”、“竖直”、“水平”、“顶”、“底”“内”、“外”等指示的方位或位置关系为基于附图所示的方位或位置关系，仅是为了便于描述本发明实施例和简化描述，而不是指示或暗示所指的装置或元件必须具有特定的方位、以特定的方位构造和操作，因此不能理解为对本发明实施例的限制。
在本发明实施例的描述中，需要说明的是，除非另有明确的规定和限定，术语“安装”、“相连”、“连接”应做广义理解，例如，可以是固定连接，也可以是可拆卸连接，或一体地连接；可以是机械连接，也可以是电连接；可以是直接相连，也可以通过中间媒介间接相连，可以是两个元件内部的连通。对于本领域的普通技术人员而言，可以具体情况理解上述术语在本发明实施例中的具体含义。
如图1和图2所示，为本发明实施例提供的一种通过推头端光缆进行半释放状态的心耳封堵器，其包括封堵器本体1、头端控制光缆2和尾端控制光缆3，所述封堵器本体1的头端通过头端螺纹套4与所述头端控制光缆2的一端连接，具体地，可以是所述尾端控制光缆3的一端设有外螺纹，所述头端螺纹套4内设有内螺纹，所述尾端控制光缆3与所述头端螺纹套4通过螺纹连接，由此两者便可以通过螺旋的方式解除固定，所述封堵器本体1的尾端通过尾端螺纹套5与所述尾端控制光缆3的一端连接，所述尾端控制光缆3呈空心柱状，所述头端控制光缆2的另一端依次穿过所述尾端螺纹套5和所述尾端控制光缆3，且所述封堵器本体1的头端位于所述封堵器本体1的尾端上方；所述封堵 器本体1呈编织的网状支架结构，其具有预设的完全释放后与心耳7结构匹配的外形，所述封堵器本体1释放前拉伸呈条状设于外鞘管6内，为了尽量减小通过推头端光缆进行半释放状态的心耳封堵器的尺寸，优选将头端螺纹套4与尾端螺纹套5的外径尺寸设置成一致，也便于安装在外鞘管6内，所述封堵器本体1推出所述外鞘管6后处于半释放状态，以能够调整所述封堵器本体1在心耳7内的位置，由于封堵器本体1处于半释放状态，因此其并没有完全与心耳7的内壁贴合(如图3所示)，从而留有调整的余地，通过推拉头端控制光缆2可以改变所述封堵器本体1的直径即改变封堵器本体1的大小，并可以通过移动尾端控制光缆3调整封堵器本体1在心耳7内的位置，两个控制光缆均可进行独立操作，互不影响，以实现将所述封堵器本体1准确地完全释放在预期的心耳7封堵位置，降低了手术的难度，提高了手术成功率。
具体地，所述头端控制光缆2的外径小于所述尾端螺纹套5和尾端控制光缆3的内径，以方便所述头端控制光缆2能够在所述尾端螺纹套5和尾端控制光缆3内移动。
其中，所述头端螺纹套4与所述尾端螺纹套5可以为螺母，所述头端螺纹套4和所述尾端螺纹套5可以分别对应焊接在所述封堵器本体1的头端和尾端，组成一个封闭的整体。
其中，所述封堵器本体1的外表面为镍钛丝编织网，将镍钛合金编织网通过热处理工艺固定成预定形状，组成所述封堵器本体1。
为了提高阻血性能，所述封堵器本体1优选由多层镍钛丝编织网编织而成，从而防止心房和心耳7的血液交换。
另外，所述封堵器本体1也可以由单层镍钛丝编织网编织而成，为了提高 阻血性能，可以在单层镍钛丝编织网内缝设有薄膜，所述薄膜优选为PET(聚对苯二甲酸乙二酯)或ePTFE膜(以聚四氟乙烯为原料经膨化拉伸形成的多微孔膜)。
进一步地，如图4所示，所述封堵器本体1完全释放后可以呈圆柱状或者上大下小的锥台状，将其放置于左心耳7开口处，通过封堵器本体1的支撑力，将封堵器本体1与心耳7内壁完全贴合(如图5所示)，通过摩擦力防止通过推头端光缆进行半释放状态的心耳封堵器移位和脱落，当然，所述封堵器本体1完全释放后也可以呈其他适宜的形状。
由以上实施例可以看出，本发明实施例能够调整封堵器在心耳7中的位置，使封堵器能够准确的释放在预期的位置，降低手术的难度，提高手术成功率；
本发明实施例的通过推头端光缆进行半释放状态的心耳封堵器根据左心耳7内腔的解剖结构进行设计，能够与心耳7结构完美匹配，达到理想的封堵效果，同时有效防止器械的移位、脱落；且降低了操作的难度，减少了重复释放的次数，减少了不良事件发生的概率。
以上所述仅为本发明实施例的较佳实施例而已，并不用以限制本发明实施例，凡在本发明实施例的精神和原则之内，所作的任何修改、等同替换、改进等，均应包含在本发明实施例的保护范围之内。

Claims (8)

  1. 一种通过推头端光缆进行半释放状态的心耳封堵器，其特征在于，包括封堵器本体、头端控制光缆和尾端控制光缆，所述封堵器本体的头端通过头端螺纹套与所述头端控制光缆的一端连接，所述封堵器本体的尾端通过尾端螺纹套与所述尾端控制光缆的一端连接，所述尾端控制光缆呈空心柱状，所述头端控制光缆的另一端依次穿过所述尾端螺纹套和所述尾端控制光缆；所述封堵器本体呈编织的网状支架结构，其具有预设的完全释放后与心耳结构匹配的外形，所述封堵器本体释放前呈条状设于外鞘管内，所述封堵器本体推出所述外鞘管后处于半释放状态，以能够调整所述封堵器本体在心耳内的位置，通过推拉头端控制光缆改变所述封堵器本体的直径，以实现将所述封堵器本体完全释放在预期的封堵位置。
  2. 根据权利要求1所述的通过推头端光缆进行半释放状态的心耳封堵器，其特征在于，所述头端控制光缆的外径小于所述尾端螺纹套和尾端控制光缆的内径。
  3. 根据权利要求1所述的通过推头端光缆进行半释放状态的心耳封堵器，其特征在于，所述头端螺纹套与所述尾端螺纹套为螺母。
  4. 根据权利要求1所述的通过推头端光缆进行半释放状态的心耳封堵器，其特征在于，所述封堵器本体的外表面为镍钛丝编织网。
  5. 根据权利要求1所述的通过推头端光缆进行半释放状态的心耳封堵器，其特征在于，所述封堵器本体由多层镍钛丝编织网编织而成。
  6. 根据权利要求1所述的通过推头端光缆进行半释放状态的心耳封堵器，其特征在于，所述封堵器本体由单层镍钛丝编织网编织而成，其内缝设有薄膜。
  7. 根据权利要求6所述的通过推头端光缆进行半释放状态的心耳封堵器，其特征在于，所述薄膜为PET或ePTFE膜。
  8. 根据权利要求1所述的通过推头端光缆进行半释放状态的心耳封堵器，其特征在于，所述头端螺纹套和所述尾端螺纹套分别与所述封堵器本体焊接连接。
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