WO2018166376A1 - 一种球囊左心耳封堵装置 - Google Patents

一种球囊左心耳封堵装置 Download PDF

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WO2018166376A1
WO2018166376A1 PCT/CN2018/078142 CN2018078142W WO2018166376A1 WO 2018166376 A1 WO2018166376 A1 WO 2018166376A1 CN 2018078142 W CN2018078142 W CN 2018078142W WO 2018166376 A1 WO2018166376 A1 WO 2018166376A1
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left atrial
atrial appendage
positioning film
support frame
occluder
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PCT/CN2018/078142
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English (en)
French (fr)
Inventor
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 WO2018166376A1 publication Critical patent/WO2018166376A1/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
    • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or 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
    • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or 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
    • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or 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
    • A61B17/12136—Balloons
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or 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
    • A61B17/12163—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a string of elements connected to each other
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or 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
    • A61B17/12181—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device formed by fluidized, gelatinous or cellular remodelable materials, e.g. embolic liquids, foams or extracellular matrices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B2017/1205—Introduction devices

Definitions

  • the invention belongs to the field of cardiac medical devices, and particularly relates to a balloon left atrial appendage occlusion device.
  • Atrial fibrillation is the most common persistent arrhythmia in the clinic. In recent years, the incidence of atrial fibrillation has increased year by year, especially in the 65-85 age group.
  • One of the most important hazards of atrial fibrillation is the induction of left atrial thrombosis. Complications such as thrombus detachment stroke and peripheral vascular embolization increase disability and mortality. At present, 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 the risk of stroke.
  • the existing standardized left atrial appendage occluder design is difficult to meet the complex and variable left atrial appendage anatomy.
  • the existing left atrial appendage occluder has many types but the structure is too uniform, which is not convenient for production and use.
  • the existing left atrial appendage occluder is almost always woven with memory alloy wire, and the cost is relatively high.
  • the patent application No. 201420704801.1 "a new type of umbrella-shaped left atrial appendage occluder" provides an umbrella-shaped left atrial appendage occlusion device, the occluder consists of an annular closure disk, a support cage, a fixed thorn and a transport locking device.
  • a thin-walled nickel-titanium alloy tube is integrally cut by laser, and is shaped by heat treatment, and the multi-layer membrane sutured on the surface of the disc is used to block the flow of the thrombus into the left atrial appendage, and the left atrial appendage is blocked by the closed disk.
  • the patented left atrial appendage occluder is relatively complicated in manufacturing process, and the occluder can only be fixed by fixed thorns.
  • the occluder is not firmly fixed, and the ideal sealing effect is not achieved, and the structure is relatively simple, and can not adapt to different anatomy.
  • the left atrial appendage of the form is relatively complicated in manufacturing process, and the occluder can only be fixed by fixed thorns.
  • the occluder is not firmly fixed, and the ideal sealing effect is not achieved, and the structure is relatively simple, and can not adapt to different anatomy.
  • the left atrial appendage of the form is relatively complicated in manufacturing process, and the occluder can only be fixed by fixed thorns.
  • the occluder is not firmly fixed, and the ideal sealing effect is not achieved, and the structure is relatively simple, and can not adapt to different anatomy.
  • the left atrial appendage of the form is relatively complicated in manufacturing process, and the occluder can only be fixed by fixed thorn
  • the invention aims to overcome the deficiencies of the prior art and provides a balloon left atrial appendage occlusion device, which has a simple structure, ensures a firm fixation of the occluder in the left atrial appendage, can adapt to the left atrial appendage of different anatomical forms, and effectively prevents The thrombus is missing.
  • a balloon left atrial appendage occlusion device includes: a delivery device and an occluder, the delivery device conveying the occluder to the inside of a left atrial appendage, the occluder comprising: a support frame, a one-way valve, a multi-segment positioning film, an infusion tube and a barb; the multi-segment positioning film is connected to the support frame; the multi-segment positioning film comprises a head end positioning film, an intermediate positioning film and an end positioning film, and the support frame comprises a front end of the support frame and a rear end of the support frame, the check valve is disposed inside the rear end of the support frame, the infusion tube is connected to the rear end of the support frame, and the plurality of positioning film is wrapped in the solution before the solution is injected Support frame surface.
  • the multi-segment positioning film is an expandable film
  • the material of the multi-segment positioning film is polyamide or polyurethane.
  • the conveying device is provided with a pipe for conveying the solution, the pipe is connected with the infusion pipe, and the conveying device is screwed with the rear end of the support frame.
  • the solution is a temperature sensitive hydrogel that changes from a liquid state to a gel state at body temperature.
  • the rear end side of the support frame is open, the support frame is provided with a cavity, the inner cavity is connected to the side opening, and the one-way valve is disposed at a position where the inner cavity and the side opening are connected .
  • the front end of the support frame is provided with an upper opening and a micro channel, a cavity is formed between the multi-segment positioning film and the micro channel, and the upper opening is disposed under the first end positioning film, the micro channel The front end is connected to the upper opening, and the rear end of the microchannel is disposed under the end positioning film.
  • the number of the intermediate positioning films is at least one, and the barbs are disposed on a surface of the intermediate positioning film closest to the left atrial appendage.
  • the head positioning film and the intermediate positioning film are installed in the left atrial appendage, and the end positioning film is installed outside the left atrial ear and closely adjacent to the left atrial ear.
  • the multi-segment positioning film is filled with the solution and is in a balloon shape, and the longitudinal positioning dimension of the end positioning film after being stretched is larger than the size of the left atrial appendage.
  • the multi-segment positioning film is connected to the support frame by a positioning ring or a fusion method.
  • the balloon occluder disclosed by the invention is installed into the left atrial appendage by the conveying device, and the solution is injected into the support frame by the conveying device, because the injection solution is used to expand the multi-segment positioning film, the solution
  • the opening and the microchannel from the front end of the support frame gradually enter the multi-segment positioning film, and the solution sequentially fills the end positioning film, the intermediate positioning film and the end positioning film to form a plurality of balloon devices.
  • the solution is a temperature-sensitive hydrogel, it changes from a liquid state to a gel state at a human body temperature.
  • the balloon device on the occluder can be closely attached to the inner wall of the left atrial appendage, and can be applied to different left auricle anatomical forms.
  • the occluder is more firmly fixed on the left atrial appendage, which can effectively prevent the occluder from falling off during operation or after surgery; and because the multi-segment positioning film is used to form a plurality of balloon devices, multi-level blocking can be formed, which is more effective in preventing The thrombus is missing.
  • the one-way valve provided in the present invention can seal the gel injected into the occluder so that the gel can stay in the multi-segment positioning film and the support frame to maintain a filled state.
  • the number of intermediate positioning films can be adjusted, which can be applied to different left atrial appendage anatomy, and the barbs provided on the intermediate positioning film can also make the occluder fixed more stably.
  • the use of the film to make the occluder of the invention has a simple structure compared with the memory alloy occluder commonly used in the prior art, and can minimize the complexity and production cost of the occluder model.
  • FIG. 1 is a schematic perspective view of the left atrial appendage occluder of the present invention after being completely erected and shaped;
  • FIG. 2 is a schematic view showing the structure of the uninjected solution after the balloon left atrial appendage occluder enters the left atrial appendage according to the present invention
  • FIG. 3 is a schematic structural view showing the expansion molding of the positioning film of the first end of the balloon after the left atrial appendage occluder enters the left atrial appendage according to the present invention
  • FIG. 4 is a schematic structural view showing the full expansion of a multi-segment positioning film after the balloon left atrial appendage occluder enters the left atrial appendage according to the present invention
  • Figure 5 is a flow diagram of the solution of the present invention after injection into the balloon left atrial appendage occluder.
  • a balloon left atrial appendage blocking device mainly comprises two major components: a conveying device and an occluder (the conveying device is not shown in the figure), The delivery device first delivers the occluder to the interior of the left atrial appendage 6, and then injects the solution into the occluder.
  • the occluder comprises: a support frame 2, a check valve 5, a multi-segment positioning film 1, an infusion tube 4 and a barb 3; the multi-segment positioning film is connected with the support frame 2, and the multi-segment positioning film can pass The positioning ring or the method of fusion is connected to the support frame 2.
  • the multi-segment positioning film 1 comprises a head end positioning film 11, an intermediate positioning film 12 and an end positioning film 13
  • the support frame 2 includes a support frame front end 22 and a support frame rear end 23, and the check valve 5 is disposed inside the support frame rear end 23, and supports The rear end 23 of the frame is provided with a side opening 21, and the infusion tube 4 is screwed to the side opening 21.
  • the conveying device is provided with a pipeline for conveying the solution, and the pipeline is connected and fixed to the infusion tube 4.
  • the front end of the conveying device is fixedly connected with the rear end 23 of the supporting frame.
  • This embodiment is preferably a threaded connection, and the occluder can be rotated after being completely installed. Open the conveyor.
  • the support frame 2 is provided with an inner cavity 24 which is connected to the rear end side opening 21 of the support frame, and the check valve 5 is disposed at a position where the inner cavity 24 of the support frame 2 and the side opening 21 are connected.
  • the front end 22 of the support frame is provided with an upper opening 25 and a microchannel 26, the upper opening 25 is connected with the inner cavity 24, a cavity is formed between the multi-segment positioning film 1 and the microchannel 26, and the upper opening 25 is disposed under the positioning film at the head end, the microchannel
  • the front end of the 26 is connected to the upper opening 25, the rear end of the microchannel 26 is disposed under the end positioning film 13, the solution is injected from the rear end 23 of the bracket into the front end 22 of the bracket, and then flows into the multi-segment positioning film 1 from the upper opening 25 and the microchannel 26, and Gradually fill the entire multi-section positioning film 1.
  • the multi-segment positioning film 1 is an expandable film, and the material of the multi-segment positioning film 1 is polyamide or polyurethane.
  • the solution used in this embodiment is a temperature-sensitive hydrogel, and the solution is converted from a liquid state to a gel state at a human body temperature, so that the multi-stage positioning film 1 filled with the solution is finally shaped into a plurality of balloon devices.
  • the longitudinal section of each segment of the balloon device is circular, and the longitudinal section size of the end positioning film 13 after being erected is larger than the size of the opening of the left atrial appendage 6.
  • the number of the intermediate positioning films 12 is at least one, and the barbs 3 are disposed on the surface of an intermediate positioning film 12 which is closest to the opening of the left atrial appendage 6.
  • the intermediate positioning film 12 is preferably two, and the intermediate positioning film includes a first intermediate positioning film and a second intermediate positioning film 121. The barbs 3 are disposed on the surface of the second intermediate positioning film 121.
  • the operation procedure in the operation of the present invention is as follows: the occluder is delivered to the left atrial appendage by the delivery device, the installation position is adjusted, and the head end positioning film 11 and the intermediate positioning film 12 are attached to the left atrial appendage 6 In the inner cavity, the end positioning film 13 is attached to the outside of the opening of the left atrial appendage 6 and abuts against the opening of the left atrial appendage 6.
  • the solution is transported by the transport device, and the solution flows into the inner chamber 24 from the side opening 21 of the rear end 23 of the support frame via the infusion tube 4. After the solution fills the inner chamber 24, it flows from the upper opening 25 of the front end 22 of the support frame into the first end positioning film 11.
  • the first end positioning film 11 is inflated and fixed in contact with the inner wall of the left atrial appendage 6, and then the solution sequentially flows into the intermediate positioning film 11 and the end positioning film 12 through the microchannel 26, so that the intermediate positioning film 11 and the end positioning film 12 are inflated and left.
  • the inner wall of the auricle 6 is tightly attached.
  • the barbs 3 provided on the surface thereof can be fixed on the inner wall of the left atrial appendage 6, which can make the occluder fixed more firmly.
  • the check valve 5 provided by the present invention can seal the solution injected into the occluder so that the solution can stay in the multi-stage positioning film 1 and the support frame 2 to maintain the filling state of the solution.
  • the injected solution When the multi-segment positioning film 1 is fully expanded, under the action of the human body's own temperature, the injected solution will change from a liquid state to a gel state at the body temperature, so that the entire occluder is completely formed, and finally the conveying device is unscrewed.
  • the multi-segment positioning film 1 Since the multi-segment positioning film 1 is filled with a solution, the multi-segment positioning film 1 can be brought into contact with the maximum and maximum area of the inner wall of the left atrial appendage 6, so that the occluder is more firmly fixed on the left atrial appendage 6, and the second intermediate positioning film The barbs 3 attached to the surface of the 121 prevent the occluder from coming off.
  • the invention can effectively avoid the phenomenon of occlusion device during or after surgery and reduce the complexity of the operation; according to the principle of film expansion, the balloon device after the occlusion device is shaped can be closely attached to the inner wall of the left atrial appendage 6 and is suitable for different
  • the left atrial appendage 6 is an anatomical shape; and because the multi-segment positioning film 1 is used to form a plurality of balloon devices, a multi-stage barrier can be formed, which is more effective in preventing thrombus leakage.
  • the number of intermediate positioning films 12 can be adjusted to suit different left atrial appendage anatomy.
  • the use of the film to make the occluder of the invention has a simple structure compared with the memory alloy occluder commonly used in the prior art, and can minimize the complexity and production cost of the occluder model.

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Abstract

一种球囊左心耳封堵装置，包括：输送装置和封堵器，输送装置先将封堵器输送至左心耳内部，再将溶液通过管道注入封堵器中。封堵器包括：支撑架（2）、单向阀（5）、多段定位薄膜（1）、输液管（4）和倒钩（3）；多段定位薄膜（1）与支撑架（2）连接，多段定位薄膜（1）包括首端定位薄膜（11）、中间定位薄膜（12）和末端定位薄膜（13），支撑架（2）包括支撑架前端（22）和支撑架后端（23），单向阀（5）设置于支撑架后端（23）内部，输液管（4）与支撑架后端（23）连接。溶液进入多段定位薄膜中，依次充满多段定位薄膜，形成多个球囊装置。封堵器上的球囊装置紧贴左心耳内壁，可以适用于不同的左心耳解剖形态，有效防止封堵器术中或术后脱落，防止血栓子遗漏，降低封堵器型号的繁杂和生产成本。

Description

一种球囊左心耳封堵装置 技术领域
本发明属于心脏医疗器械领域，具体涉及一种球囊左心耳封堵装置。
背景技术
心房颤动是临床上最常见的持续性心律失常，近年来房颤的发病率逐年上升，尤其是在65～85年龄中发病率最高；而且房颤最主要的危害之一是诱发左心房血栓形成，血栓脱落卒中、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，降低脑卒中风险等。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残余漏，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，增加了手术中或手术后的复杂性。现有标准化的左心耳封堵器设计难以满足复杂多变的左心耳解剖形态，为适应不同解剖形态的左心耳，现有左心耳封堵器型号繁多但结构过于统一，不便于生产及使用。而且现有的左心耳封堵器几乎都采用记忆合金丝编织，成本比较高。
申请号为201420704801.1的专利“一种新型伞状左心耳封堵器”，提供了一种伞状左心耳封堵器械，封堵器由环形封闭盘、支撑笼、固定刺和输送锁定装置组成，通过激光整体切割一根薄壁镍钛合金管，通过热处理旋转压缩制作定型，通过封闭盘表面缝合的多层膜来阻挡血栓流入左心耳，利用封闭盘封堵左心耳口。该专利的左心耳封堵器制作工艺较为复杂，而且仅能通过固定刺来固定封堵器，封堵器固定不牢固，达不到理想的封堵效果，而且结构较为单一，无法适应不同解剖形态的左心耳。
发明内容
本发明目的在于克服现有技术的不足，提供了一种球囊左心耳封堵装置，结构简单，确保封堵器在左心耳内的牢固固定，可以适应不同解剖形态的左心耳，并且有效防止血栓子遗漏。
为达到上述目的，一种球囊左心耳封堵装置，包括：输送装置和封堵器，所述输送装置将所述封堵器输送至左心耳内部，所述封堵器包括：支撑架、单向阀、多段定位薄膜、输液管和倒钩；所述多段定位薄膜与所述支撑架连接；所述多段定位薄膜包括首端定位薄膜、中间定位薄膜和末端定位薄膜，所述支撑架包括支撑架前端和支撑架后端，所述单向阀设置于所述支撑架后端内部，所述输液管与所述支撑架后端连接，所述多段定位薄膜在注入溶液前包裹于所述支撑架表面。
优选的，所述多段定位薄膜为可膨胀薄膜，所述多段定位薄膜的材料为聚酰胺或者聚氨酯。
优选的，所述输送装置中铺设有输送溶液的管道，所述管道与所述输液管连接，所述输送装置与所述支撑架后端通过螺纹连接。
优选的，所述溶液为温敏水凝胶，所述溶液在人体温度下由液态转变为凝胶状态。
优选的，所述支撑架后端侧开口，所述支撑架设有内腔，所述内腔与所述侧开口连接，所述单向阀设置于所述内腔和所述侧开口连接的位置。
优选的，所述支撑架前端设有上开口和微通道，所述多段定位薄膜与所述微通道之间形成空腔，所述上开口设置于所述首端定位薄膜下方，所述微通道前端与所述上开口连接，所述微通道后端设置于所述末端定位薄膜下方。
优选的，所述中间定位薄膜的数量至少为1个，所述倒钩设置于最接近左心耳口的一个所述中间定位薄膜表面。
优选的，所述首端定位薄膜和所述中间定位薄膜安装于所述左心耳内腔中，所述末端定位薄膜安装于所述左心耳口外部并紧贴左心耳口。
优选的，所述多段定位薄膜注满所述溶液撑起后为球囊状，所述末端定位薄膜撑起后的纵截面尺寸大于左心耳口的尺寸。
优选的，所述多段定位薄膜通过定位环或者融合的方法与所述支撑架连接。
本发明的有益效果：本发明公开的球囊封堵器通过输送装置安装到左心耳后，通过输送装置将溶液注入到支撑架中，因为采用的是注射溶液使多段定位薄膜膨胀的原理，溶液从支撑架前端的开口和微通道逐渐进入多段定位薄膜中，溶液依次充满端定位薄膜、中间 定位薄膜和末端定位薄膜，形成多个球囊装置。由于溶液为温敏水凝胶，在人体温度下由液态转变为凝胶状态，根据薄膜膨胀的原理，可以使封堵器上的球囊装置紧贴左心耳内壁，可以适用于不同的左心耳解剖形态，使封堵器更加牢固固定在左心耳上，可以有效防止封堵器术中或术后脱落；而且由于采用的多段定位薄膜形成多个球囊装置，可以形成多级阻挡，更加有效的防止血栓子遗漏。
本发明中设置的单向阀可以密封注射进封堵器的凝胶，使得凝胶能够停留在多段定位薄膜和支撑架内，保持充盈的状态。
中间定位薄膜数量可以进行调整，可以适用于不同的左心耳解剖形态，同时中间定位薄膜上设置的倒钩也可以使封堵器固定的更加稳定。本发明的采用薄膜来制作封堵器，相比现有技术中常用的记忆合金封堵器，结构简单，可以最大程度降低封堵器型号的繁杂和生产成本。
附图说明
图1为本发明球囊左心耳封堵器完全撑起定型后的立体结构示意图；
图2为本发明球囊左心耳封堵器进入左心耳后未注射溶液的结构示意图；
图3为本发明球囊左心耳封堵器进入左心耳后首端定位薄膜膨胀成形的结构示意图；
图4为本发明球囊左心耳封堵器进入左心耳后多段定位薄膜完全膨胀成形的结构示意图；
图5为本发明溶液注入球囊左心耳封堵器后的流动示意图。
具体实施方式
下面结合附图对本发明的具体实施方式作进一步说明：
如图2所示，本发明采用的技术方案如下：一种球囊左心耳封堵装置，主要有两大部分组成：包括：输送装置和封堵器(输送装置在图中未示出)，输送装置先将封堵器输送至左心耳6内部，再将溶液注入所述封堵器中。
结合图1和图5所示，封堵器包括：支撑架2、单向阀5、多段定位薄膜1、输液管4和倒钩3；多段定位薄膜与支撑架2连接，多段定位薄膜可以通过定位环或者融合的方法与支撑架2连接。多段定位薄膜1包括首端定位薄膜11、中间定位薄膜12和末端定位薄膜13，支撑架2包括支撑架前端22和支撑架后端23，单向阀5设置于支撑架后端23内部， 支撑架后端23设有侧开口21，输液管4与侧开口21螺旋连接。
输送装置中铺设有输送溶液的管道，该管道与输液管4连接固定，输送装置前端与支撑架后端23通过连接固定，本实施例优选为螺纹连接，将封堵器完全安装好之后可以旋开输送装置。
支撑架2设置有内腔24，内腔24与支撑架后端侧开口21连接，单向阀5设置于支撑架2的内腔24和侧开口21连接的位置。支撑架前端22设有上开口25和微通道26，上开口25和内腔24连接，多段定位薄膜1与微通道26之间形成空腔，上开口25设置于首端定位薄膜下方，微通道26前端与上开口25连接，微通道26后端设置于末端定位薄膜13下方，溶液从支架后端23注入支架前端22，再从上开口25和微通道26流入到多段定位薄膜1中，并逐渐充满整个多段定位薄膜1。
多段定位薄膜1为可膨胀薄膜，多段定位薄膜1的材料为聚酰胺或者聚氨酯。本实施例采用的溶液为温敏水凝胶，该溶液会在人体温度下由液态转变为凝胶状态，使充满溶液后的多段定位薄膜1最后定型为多个球囊装置。各段球囊装置的纵截面为圆形，末端定位薄膜13撑起后的纵截面尺寸大于左心耳6开口的尺寸。
中间定位薄膜12的数量至少为1个，倒钩3设置于最接近左心耳6开口的一个中间定位薄膜12表面。本实施例优选的中间定位薄膜12为2个，中间定位薄膜包括第一中间定位薄膜和第二中间定位薄膜121，倒钩3设置于第二中间定位薄膜121表面。
如图2-4所示，本发明的手术中操作流程如下：通过输送装置将封堵器输送到左心耳处，调节安装位置，将首端定位薄膜11和中间定位薄膜12安装于左心耳6内腔中，末端定位薄膜13安装于左心耳6开口外部并紧贴左心耳6开口的位置。通过输送装置输送溶液，溶液经输液管4从支撑架后端23的侧开口21流入内腔24中，溶液充满内腔24后，从支撑架前端22的上开口25流入首端定位薄膜11中，使首端定位薄膜11膨胀并与左心耳6内壁接触固定，然后溶液通过微通道26依次流入中间定位薄膜11和末端定位薄膜12中，使中间定位薄膜11和末端定位薄膜12膨胀并与左心耳6内壁紧贴固定。第二中间定位薄膜121完全膨胀后，其表面设置的倒钩3可以固定在左心耳6内壁，可以使封堵器固定更加牢固。本发明设置的单向阀5可以密封注射进封堵器的溶液，使得溶液能够停留在多段定位薄膜1和支撑架2内，保持溶液的充盈状态。当多段定位薄膜1完全膨胀后，在人体自身温度作用下，注射的溶液会在人体温度下由液态转变为凝胶状态，使整个封堵器成型完全，最后旋开输送装置。
由于多段定位薄膜1里面注射的是溶液，所以可以使多段定位薄膜1与左心耳6内壁最大程度和最大面积接触，使封堵器更加牢固的固定在左心耳6上，同时第二中间定位薄膜121表面附有的倒钩3可以防止封堵器脱落。本发明可以有效避免出现封堵器术中或术后脱落现象，降低手术的复杂性；根据薄膜膨胀的原理，可以使封堵器定型后的球囊装置紧贴左心耳6内壁，适用于不同的左心耳6解剖形态；而且由于采用的多段定位薄膜1形成多个球囊装置，可以形成多级阻挡，更加有效的防止血栓子遗漏。中间定位薄膜数量12可以进行调整，可以适用于不同的左心耳解剖形态。本发明的采用薄膜来制作封堵器，相比现有技术中常用的记忆合金封堵器，结构简单，可以最大程度降低封堵器型号的繁杂和生产成本。
根据上述说明书的揭示和教导，本发明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，本发明并不局限于上面揭示和描述的具体实施方式，对发明的一些修改和变更也应当落入本发明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，并不对本发明构成任何限制。

Claims (10)

  1. 一种球囊左心耳封堵装置，包括：输送装置和封堵器，所述输送装置将所述封堵器输送至左心耳内部，其特征在于，所述封堵器包括：支撑架、单向阀、多段定位薄膜、输液管和倒钩；所述多段定位薄膜与所述支撑架连接；所述多段定位薄膜包括首端定位薄膜、中间定位薄膜和末端定位薄膜，所述支撑架包括支撑架前端和支撑架后端，所述单向阀设置于所述支撑架后端内部，所述输液管与所述支撑架后端连接，所述多段定位薄膜在注入溶液前包裹于所述支撑架表面。
  2. 根据权利要求1所述的一种球囊左心耳封堵装置，其特征在于，所述多段定位薄膜为可膨胀薄膜，所述多段定位薄膜的材料为聚酰胺或者聚氨酯。
  3. 根据权利要求1所述的一种球囊左心耳封堵装置，其特征在于，所述输送装置中铺设有输送溶液的管道，所述管道与所述输液管连接，所述输送装置与所述支撑架后端通过螺纹连接。
  4. 根据权利要求3所述的一种球囊左心耳封堵装置，其特征在于，所述溶液为温敏水凝胶，所述溶液在人体温度下由液态转变为凝胶状态。
  5. 根据权利要求1所述的一种球囊左心耳封堵装置，其特征在于，所述支撑架后端侧开口，所述支撑架设有内腔，所述内腔与所述侧开口连接，所述单向阀设置于所述内腔和所述侧开口连接的位置。
  6. 根据权利要求1所述的一种球囊左心耳封堵装置，其特征在于，所述支撑架前端设有上开口和微通道，所述多段定位薄膜与所述微通道之间形成空腔，所述上开口设置于所述首端定位薄膜下方，所述微通道前端与所述上开口连接，所述微通道后端设置于所述末端定位薄膜下方。
  7. 根据权利要求1所述的一种球囊左心耳封堵装置，其特征在于，所述中间定位薄膜的数量至少为1个，所述倒钩设置于最接近左心耳口的一个所述中间定位薄膜表面。
  8. 根据权利要求1所述的一种球囊左心耳封堵装置，其特征在于，所述首端定位薄膜和所述中间定位薄膜安装于所述左心耳内腔中，所述末端定位薄膜安装于所述左心耳口外部并紧贴左心耳口。
  9. 根据权利要求1所述的一种球囊左心耳封堵装置，其特征在于，所述多段定位薄膜注满所述溶液撑起后为球囊状，所述末端定位薄膜撑起后的纵截面尺寸大于左心耳口的尺寸。
  10. 根据权利要求1所述的一种球囊左心耳封堵装置，其特征在于，所述多段定位薄膜通过定位环或者融合的方法与所述支撑架连接。
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