WO2022257343A1 - 一种双球囊溶栓取栓装置 - Google Patents

一种双球囊溶栓取栓装置 Download PDF

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Publication number
WO2022257343A1
WO2022257343A1 PCT/CN2021/128040 CN2021128040W WO2022257343A1 WO 2022257343 A1 WO2022257343 A1 WO 2022257343A1 CN 2021128040 W CN2021128040 W CN 2021128040W WO 2022257343 A1 WO2022257343 A1 WO 2022257343A1
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Prior art keywords
balloon
lumen
thrombolysis
double
access sheath
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PCT/CN2021/128040
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English (en)
French (fr)
Inventor
许永松
郭琦
廖芝美
王锐
唐航
吴健
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北京泰杰伟业科技有限公司
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Priority to US18/558,101 priority Critical patent/US20240216655A1/en
Publication of WO2022257343A1 publication Critical patent/WO2022257343A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M25/1011—Multiple balloon catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M25/1018—Balloon inflating or inflation-control devices
    • A61M25/10181—Means for forcing inflation fluid into the balloon
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22051—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation
    • A61B2017/22054—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation with two balloons
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22051—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation
    • A61B2017/22062—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation to be filled with liquid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22051—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation
    • A61B2017/22065—Functions of balloons
    • A61B2017/22067—Blocking; Occlusion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22079—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with suction of debris
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M25/1011—Multiple balloon catheters
    • A61M2025/1013—Multiple balloon catheters with concentrically mounted balloons, e.g. being independently inflatable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/105—Balloon catheters with special features or adapted for special applications having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/1052—Balloon catheters with special features or adapted for special applications for temporarily occluding a vessel for isolating a sector

Definitions

  • the invention relates to the field of medical devices, in particular to a double-balloon thrombolysis and thrombectomy device.
  • the object of the present invention is to provide a double-balloon thrombolysis and thrombectomy device.
  • a double-balloon catheter inject physiological saline into the first balloon at the distal end of the double-balloon catheter, so that the second The first balloon is inflated and attached to the inner wall of the blood vessel to block the distal blood flow and prevent the emboli from escaping.
  • the thrombolytic drug is injected into the second balloon, and the thrombolytic drug is released into the blood vessel through the micropores on the surface of the second balloon Perform thrombolysis, and after the end of thrombolysis, apply negative pressure to the inner cavity of the access sheath through the hemostatic Y valve to suck out the dissolved thrombus; greatly shorten the time window of surgical treatment and improve the clinical prognosis. Protection, preventing emboli from escaping, making surgery safer.
  • the present invention provides a double-balloon thrombolysis and thrombectomy device, comprising:
  • a double-balloon microcatheter comprises a three-way tube base, a tube body, a first balloon and a second balloon; the distal end of the three-way tube base is connected to the proximal end of the tube body; the first ball The balloon and the second balloon are sleeved outside the tubular body; the first balloon is located at the distal end of the tubular body, and the second balloon is located at the proximal end of the first balloon;
  • the three-way socket includes a main interface, a first interface, and a second interface; the pipe body includes a body cavity, a first lumen, and a second lumen; the first lumen and the second lumen are respectively located in the on the inner wall of the inner cavity of the tube; the first balloon and the first interface are connected through the first lumen; the second balloon and the second interface are connected through the second lumen; the The lumen of the tube is connected to the main interface; a plurality of micropores are evenly distributed on the surface of the second balloon;
  • an access sheath sleeved outside the tubular body, the distal end of the access sheath is located at the proximal end of the second balloon;
  • the hemostatic Y valve is sleeved outside the tubular body, and the proximal end of the access sheath is fixedly connected to the tubular body through the hemostatic Y valve;
  • the guide wire passing through the lumen of the tube pushes the double-balloon catheter into the blood vessel, pushes the first balloon to the distal end of the vascular embolism site, and makes the second balloon embedded in the blood vessel
  • the embolism site inject physiological saline into the first balloon through the first interface, and the first balloon is inflated and fully adheres to the inner wall of the blood vessel to prevent thrombus from escaping;
  • Thrombolytic drugs are injected into the second balloon, pressure is generated inside the second balloon, micropores on the surface of the second balloon are opened, and the thrombolytic drugs are released to the vascular embolism site through the micropores for Thrombolysis: applying negative pressure to the lumen of the access sheath through the hemostatic Y-valve to suck out the dissolved thrombus.
  • the tube body in the first balloon has a first positioning mark
  • the tube body in the second balloon has a second positioning mark
  • the distal end of the access sheath has a third positioning mark.
  • the micropores on the surface of the second balloon are pressure-responsive micropores, the number of the micropores is 2-10, and the diameter of the micropores is 20-100 microns.
  • the distance between the first balloon and the second balloon is 1-3 cm;
  • the first balloon is a compliance balloon, and the material of the first balloon is silica gel or thermoplastic polyurethane;
  • the second balloon is a compliance balloon or a semi-compliance balloon, and the material of the second balloon is silica gel, thermoplastic polyurethane or block polyetheramide polymer.
  • the outer diameter of the pipe body is 1.8-3.2F
  • the inner diameter of the pipe body is 0.015-0.027 inches
  • the length of the pipe body is 140-160 cm.
  • the outer diameter of the access sheath is 5-8F
  • the inner diameter of the access sheath is 0.058-0.088 inches
  • the length of the access sheath is 90-120 cm.
  • An embodiment of the present invention provides a double-balloon thrombolysis and thrombectomy device.
  • a double-balloon catheter inject physiological saline into the first balloon at the distal end of the double-balloon catheter, so that the first balloon expands and connects with the blood vessel.
  • the inner wall is adhered to block the distal blood flow and prevent the emboli from escaping.
  • the thrombolytic drug is injected into the second balloon, and the thrombolytic drug is released into the blood vessel through the micropores on the surface of the second balloon for thrombolysis.
  • Fig. 1 is a schematic structural view of a dual-balloon thrombolysis and thrombectomy device provided by an embodiment of the present invention.
  • An embodiment of the present invention provides a double-balloon thrombolysis and thrombectomy device.
  • a double-balloon catheter inject physiological saline into the first balloon at the distal end of the double-balloon catheter, so that the first balloon expands and connects with the blood vessel.
  • the inner wall is adhered to block the distal blood flow and prevent the emboli from escaping.
  • the thrombolytic drug is injected into the second balloon, and the thrombolytic drug is released into the blood vessel through the micropores on the surface of the second balloon for thrombolysis.
  • Fig. 1 is a schematic structural view of a dual-balloon thrombolysis and thrombectomy device provided by an embodiment of the present invention. As shown in Fig. Hemostasis Y-valve3.
  • the double-balloon thrombolysis and thrombectomy device provided in the embodiment of the present invention can be applied to intravascular local thrombolysis, and can complete the thrombolysis and thrombus removal operation in a short time.
  • the double-balloon catheter 1 is located in the lumen of the access sheath 2, and the two can be moved or pushed relative to each other.
  • the blood vessel Y-valve 3 is used to connect the proximal end of the access sheath 2 with the double-balloon catheter 1 as a whole .
  • the outer diameter of the access sheath 2 is 5-8F ("F” is the French measurement system unit of the diameter of the medical catheter, 1F ⁇ 0.33mm), the inner diameter is 0.058-0.088 inches, and the length is 90-120cm.
  • the double balloon catheter 1 comprises a three-way tube base 11, a tube body 12, a first balloon 13 and a second balloon 14, wherein the distal end of the three-way tube base 11 is connected to the proximal end of the tube body 12;
  • the balloon 13 and the second balloon 14 are respectively sleeved outside the tubular body 12, the first balloon 13 is located at the distal end of the tubular body 12, the second balloon 14 is located at the proximal end of the first balloon 13, and the first balloon 14 is located at the proximal end of the first balloon 13.
  • the distance between the balloon 13 and the second balloon 14 is 1-3 cm.
  • the outer diameter of the tubular body 12 of the double balloon catheter 1 is 1.8-3.2F
  • the inner diameter of the tubular body 12 is 0.015-0.027 inches
  • the length of the tubular body 12 is 140-160 cm.
  • the three-way socket 11 has a main interface, a first interface and a second interface
  • the tube body 12 has a tube inner cavity, a first cavity and a second cavity; wherein, the first cavity and the second cavity are respectively located in the tube body
  • the proximal end of the inner cavity of the tube communicates with the main interface of the three-way socket 11
  • the proximal end of the first cavity communicates with the first interface of the three-way socket 11
  • the far end of the first cavity It communicates with the lumen of the first balloon 13
  • the proximal end of the second lumen communicates with the second interface of the three-way socket 11
  • the distal end of the second lumen communicates with the lumen of the second balloon 14 .
  • the first balloon 13 is a compliant balloon, made of silicone, thermoplastic polyurethane and other elastic polymer materials, its diameter can increase significantly with the increase of expansion pressure, and the first balloon 13 is used to expand rapidly and fit the vascular embolism The inner wall of the distal blood vessel is temporarily blocked to prevent the broken small emboli generated during the operation from escaping to the distal end.
  • the second balloon 14 is a compliant balloon or a semi-compliant balloon, made of polymer materials such as silica gel, thermoplastic polyurethane or block polyetheramide polymer.
  • the second balloon 14 is used to provide thrombolytic drugs to perform local thrombolytic therapy on the thrombus at the vascular embolism site, and a plurality of micropores 142 are evenly distributed on the surface of the balloon body of the second balloon 14, and the diameter of the micropores 142 20 to 100 microns, and the number is generally set to 2 to 10; the micropores 142 are pressure-responsive micropores.
  • the microhole 142 is in a closed state to prevent air from entering the inner cavity of the second balloon 14 before use.
  • first balloon 13 and the second balloon 14 When the first balloon 13 and the second balloon 14 are not inflated, their outer diameters are equal to or slightly larger than the outer diameter of the tubular body 12, but this does not affect the double-balloon catheter 1 in the access sheath 2 delivery.
  • the tube body 12 is provided with a first positioning mark 131 and a second positioning mark 141, wherein the first positioning mark 131 is set on the tube body inside the first balloon 13, and the second positioning mark 141 is set on the second balloon 14 on the inner tube.
  • a third positioning mark 21 is also provided at the distal end of the access sheath 2 . Positioning markers are used for intraoperative visualization.
  • the guide wire enters the inner cavity of the tube body 12 through the main interface of the three-way socket 11, and pushes the double-balloon catheter 1 into the blood vessel until the first balloon 13 passes through the vascular embolism site and reaches the blood vessel The distal end of the embolization site, and when the second balloon 14 is just inserted into the embolization site, stop pushing.
  • the first balloon 13 Inject physiological saline into the first balloon 13 through the first interface of the three-way socket 11, the first balloon 13 inflates and completely fits the inner wall of the blood vessel, temporarily blocks the blood flow at the distal end, and prevents small thrombus from The distal end escapes; and then inject thrombolytic drugs into the second balloon 14 through the second interface of the three-way socket 11, so that the second balloon 14 expands outward, and mechanically squeezes the clotted thrombus, causing the thrombus to split into
  • the pressure-responsive micropores on the surface of the second balloon 14 are opened, and the medicine for softening thrombus or thrombolysis is released from the inside of the second balloon 14 into the blood vessel, so that The thrombus becomes easier to suck; after about 5 to 10 minutes, the drug in the second balloon 14 is released, and the second balloon 14 returns to the initial contraction state.
  • Negative pressure is applied to the lumen of the access sheath 2, and the suction
  • the embodiment of the present invention provides a double-balloon thrombolysis and thrombectomy device.
  • a double-balloon catheter inject physiological saline into the first balloon at the distal end of the double-balloon catheter, so that The first balloon is inflated and attached to the inner wall of the blood vessel to block the distal blood flow and prevent the emboli from escaping.
  • the thrombolytic drug is injected into the second balloon, and the thrombolytic drug is released into the blood vessel through the micropores on the surface of the second balloon.

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Abstract

一种双球囊溶栓取栓装置，包括双球囊导管（1）、通路鞘管（2）和止血Y阀（3）；双球囊导管（1）包括三通管座（11）、管体（12）、第一球囊（13）和第二球囊（14）；第一球囊（13）和第二球囊（14）套接在管体（12）外，第一球囊（13）位于管体（12）的远端，第二球囊（14）位于第一球囊（13）的近端；三通管座（11）与管体（12）的近端相连接，包括主接口、第一接口和第二接口；管体（12）包括管体内腔、第一腔道和第二腔道；第一腔道和第二腔道位于管体内腔的内壁上，第一球囊（13）通过第一腔道与第一接口相连接，第二球囊（14）通过第二腔道与第二接口相连接；第二球囊（14）表面有多个微孔（142）；通路鞘管（2）套接在管体（12）外，位于第二球囊（14）的近端处，通过止血Y阀（3）与管体（12）固定连接。本装置集溶栓取栓于一体，缩短手术时间，并在远端防止血栓逃逸，使手术更加安全。

Description

一种双球囊溶栓取栓装置
本申请要求于2021年06月09日提交中国专利局、申请号为202110645075.5、发明名称为“一种双球囊溶栓取栓装置”的中国专利申请的优先权。
技术领域
本发明涉及医疗器械领域，尤其涉及一种双球囊溶栓取栓装置。
背景技术
目前，对于急性缺血性脑卒中的治疗主要有两种，一种是采用单纯的药物溶栓治疗，这种方法往往是通过静脉注射溶栓药物，一旦静脉溶栓失败或者没有达到预期，则需要重新进行股动脉穿刺，进而进行支架取栓手术或血管抽吸术，对患者而言，既增加了手术过程中的创伤点，又延长了治疗的时间窗，即使后面手术成功，临床预后效果也会变差；另一种是采用单纯的支架取栓手术或血管抽吸术，都会面临远端栓子的逃逸，目前市面上的各类远端保护器(滤网编织型或带金属骨架的聚氨酯模型)多是用于颈动脉等较粗的血管，颅内血管卒中通常发生在大脑动脉中的M1或M2，甚至更远端，传统的栓子保护器无法直接到位保护。
发明内容
为了克服现有技术的不足，本发明目的是提供一种双球囊溶栓取栓装置，通过使用双球囊导管，向双球囊导管远端的第一球囊内注入生理盐水，使第一球囊膨胀并与血管内壁贴合，阻断远端血流，防止栓子逃逸，向第 二球囊内注入溶栓药物，溶栓药物通过第二球囊表面的微孔释放至血管内进行溶栓，并在溶栓结束后通过止血Y阀向通路鞘管的内腔施加负压，将溶解的血栓吸出；大大缩短手术治疗时间窗，提高临床预后效果，整个过程都带有远端保护，防止栓子逃逸，使手术更加安全。
为了实现上述目的，本发明提供了一种双球囊溶栓取栓装置，包括：
双球囊微导管，包括三通管座、管体、第一球囊和第二球囊；所述三通管座的远端与所述管体的近端相连接；所述第一球囊和第二球囊分别套接在所述管体之外；所述第一球囊位于所述管体的远端，所述第二球囊位于所述第一球囊的近端；所述三通管座包括主接口、第一接口和第二接口；所述管体包括管体内腔、第一腔道和第二腔道；所述第一腔道和第二腔道分别位于所述管体内腔的内壁上；所述第一球囊和第一接口通过所述第一腔道相连接；所述第二球囊和第二接口通过所述第二腔道相连接；所述管体内腔与所述主接口相连接；所述第二球囊表面均匀分布有多个微孔；
通路鞘管，套接在所述管体之外，所述通路鞘管的远端位于所述第二球囊的近端处；
止血Y阀，套接在所述管体之外，所述通路鞘管的近端与所述管体通过所述止血Y阀固定连接；
穿过所述管体内腔的导引丝将所述双球囊导管推入血管内，将所述第一球囊推送至血管栓塞部位的远端，使所述第二球囊嵌入所述血管栓塞部位；通过所述第一接口向所述第一球囊内注入生理盐水，所述第一球囊膨胀并与血管内壁完全贴合，防止血栓逃逸；通过所述第二接口向所述第二球囊内注入溶栓药物，所述第二球囊内部产生压力，所述第二球囊表面的微孔张开，所述溶栓药物通过所述微孔释放至所述血管栓塞部位进行溶栓；通过所述止血Y阀向所述通路鞘管的内腔施加负压，将溶解的血栓吸出。
优选的，所述第一球囊内的所述管体上具有第一定位标记，所述第二球囊内的所述管体上具有第二定位标记，所述通路鞘管的远端的所述管体上具 有第三定位标记。
优选的，所述第二球囊表面的微孔为压力响应型微孔，所述微孔的数量为2～10个，所述微孔的直径为20～100微米。
优选的，所述第一球囊和第二球囊的间距为1～3cm；
所述第一球囊为顺应性球囊，所述第一球囊的材质为硅胶或热塑性聚氨酯；
所述第二球囊为顺应性球囊或半顺应性球囊，所述第二球囊的材质为硅胶、热塑性聚氨酯或嵌段聚醚酞胺聚合物。
优选的，所述管体的外径为1.8～3.2F，所述管体的内径为0.015～0.027英寸，所述管体的长度为140～160cm。
优选的，所述通路鞘管的外径为5～8F，所述通路鞘管的内径为0.058～0.088英寸，所述通路鞘管的长度为90～120cm。
本发明实施例提供了一种双球囊溶栓取栓装置，通过使用双球囊导管，向双球囊导管远端的第一球囊内注入生理盐水，使第一球囊膨胀并与血管内壁贴合，阻断远端血流，防止栓子逃逸，向第二球囊内注入溶栓药物，溶栓药物通过第二球囊表面的微孔释放至血管内进行溶栓，并在溶栓结束后通过止血Y阀向通路鞘管的内腔施加负压，将溶解的血栓吸出；大大缩短了手术治疗的时间窗，提高临床预后效果，整个过程都带有远端保护，防止栓子逃逸，使手术更加安全。
附图说明
图1为本发明实施例提供的一种双球囊溶栓取栓装置的结构示意图。
具体实施方式
下面通过附图和实施例，对本发明的技术方案做进一步的详细描述。
本发明实施例提供了一种双球囊溶栓取栓装置，通过使用双球囊导管， 向双球囊导管远端的第一球囊内注入生理盐水，使第一球囊膨胀并与血管内壁贴合，阻断远端血流，防止栓子逃逸，向第二球囊内注入溶栓药物，溶栓药物通过第二球囊表面的微孔释放至血管内进行溶栓，并在溶栓结束后通过止血Y阀向通路鞘管的内腔施加负压，将溶解的血栓吸出；大大缩短了手术治疗的时间窗，提高临床预后效果，整个过程都带有远端保护，防止栓子逃逸，使手术更加安全。
图1为本发明实施例提供的一种双球囊溶栓取栓装置的结构示意图，如图1所示，双球囊溶栓取栓装置包括：双球囊导管1、通路鞘管2和止血Y阀3。
本发明实施例提供的双球囊溶栓取栓装置可应用于血管内局部溶栓治疗，可在短时间内完成溶栓取栓手术。
双球囊导管1位于通路鞘管2的内腔中，两者之间可以相对移动或推送，血管Y阀3用于将通路鞘管2的近端与双球囊导管1固定连接成一个整体。
通路鞘管2的外径是5～8F(“F”是医用导管直径的法式计量体系单位，1F≈0.33mm)，内径是0.058～0.088英寸，长度为90～120cm。
双球囊导管1包括三通管座11、管体12、第一球囊13和第二球囊14，其中，三通管座11的远端与管体12的近端相连接；第一球囊13和第二球囊14分别套接在管体12之外，第一球囊13位于管体12的远端，第二球囊14位于第一球囊13的近端，第一球囊13和第二球囊14之间的间距为1～3cm。
双球囊导管1的管体12的外径为1.8～3.2F，管体12的内径是0.015～0.027英寸，管体12的长度为140～160cm。
三通管座11具有主接口、第一接口和第二接口，管体12具有管体内腔、第一腔道和第二腔道；其中，第一腔道和第二腔道分别位于管体内腔的内壁上，管体内腔的近端与三通管座11的主接口相连通，第一腔道的近端与三通管座11的第一接口相连通，第一腔道的远端与第一球囊13的内腔相连通，第二腔道的近端与三通管座11的第二接口相连通，第二腔道的远端与第二球 囊14的内腔相连通。
第一球囊13为顺应性球囊，材质选用硅胶、热塑性聚氨酯等弹性好的聚合物材料，随扩张压力的增加其直径能够明显增加，第一球囊13用于迅速膨胀并贴合血管栓塞部位远端的血管内壁，临时阻断远端的血管，防止在手术中产生的碎小的栓子向远端逃逸。
第二球囊14为顺应性球囊或半顺应性球囊，材质选用硅胶、热塑性聚氨酯或嵌段聚醚酞胺聚合物等聚合物材料。第二球囊14用于提供溶栓药物，对血管栓塞部位的血栓进行局部溶栓治疗，在第二球囊14的球囊体表面均匀的分布有多个微孔142，微孔142的直径为20～100微米，数量一般设置为2～10个；微孔142为压力响应型微孔，在未施压的状态下，即未向第二球囊14内部注入溶栓药物的情况下，微孔142呈关闭状态，防止在使用前空气进入第二球囊14的内腔中。
第一球囊13和第二球囊14在未充压的状态下，它们的外径与管体12的外径持平或略微偏大，但不影响双球囊导管1在通路鞘管2中的输送。
管体12上设置有第一定位标记131和第二定位标记141，其中，第一定位标记131设置于第一球囊13内的管体上，第二定位标记141设置于第二球囊14内的管体上。在通路鞘管2的远端处还设置有第三定位标记21。定位标记用于术中显影观察。
本发明实施例具体工作过程如下：
手术时，导引丝通过三通管座11的主接口进入管体12的管体内腔中，将双球囊导管1推入血管内，直至第一球囊13穿过血管栓塞部位并到达血管栓塞部位的远端，并且第二球囊14刚好嵌入血管栓塞部位时，停止推送。通过三通管座11的第一接口向第一球囊13内注入生理盐水，第一球囊13膨胀并与血管内壁完全贴合，临时阻断远端的血流，防止碎小的血栓向远端逃逸；再通过三通管座11的第二接口向第二球囊14的内部注入溶栓药物，使第二球囊14向外扩张，机械挤压成块的血栓，使血栓分裂成小块，同时，由于第 二球囊14内的压力，使第二球囊14表面的压力响应型微孔打开，从第二球囊14内部向血管内释放软化血栓或溶栓的药物，使血栓变得更易于抽吸；约5～10分钟后，第二球囊14内的药物释放完毕，第二球囊14恢复为初始的收缩状态，此时，通过止血Y阀3上的接口向通路鞘管2的内腔施加负压，持续抽吸3～30秒，将碎小的血栓吸出，实现血管的完全开通。
相对于现有技术而言，本发明实施例提供了一种双球囊溶栓取栓装置，通过使用双球囊导管，向双球囊导管远端的第一球囊内注入生理盐水，使第一球囊膨胀并与血管内壁贴合，阻断远端血流，防止栓子逃逸，向第二球囊内注入溶栓药物，溶栓药物通过第二球囊表面的微孔释放至血管内进行溶栓，并在溶栓结束后通过止血Y阀向通路鞘管的内腔施加负压，将溶解的血栓吸出；大大缩短了手术治疗的时间窗，提高临床预后效果，整个过程都带有远端保护，防止栓子逃逸，使手术更加安全。
以上所述的具体实施方式，对本发明的目的、技术方案和有益效果进行了进一步详细说明，所应理解的是，以上所述仅为本发明的具体实施方式而已，并不用于限定本发明的保护范围，凡在本发明的精神和原则之内，所做的任何修改、等同替换、改进等，均应包含在本发明的保护范围之内。

Claims (6)

  1. 一种双球囊溶栓取栓装置，其特征在于，所述装置包括：
    双球囊微导管，包括三通管座、管体、第一球囊和第二球囊；所述三通管座的远端与所述管体的近端相连接；所述第一球囊和第二球囊分别套接在所述管体之外；所述第一球囊位于所述管体的远端，所述第二球囊位于所述第一球囊的近端；所述三通管座包括主接口、第一接口和第二接口；所述管体包括管体内腔、第一腔道和第二腔道；所述第一腔道和第二腔道分别位于所述管体内腔的内壁上；所述第一球囊和第一接口通过所述第一腔道相连接；所述第二球囊和第二接口通过所述第二腔道相连接；所述管体内腔与所述主接口相连接；所述第二球囊表面均匀分布有多个微孔；
    通路鞘管，套接在所述管体之外，所述通路鞘管的远端位于所述第二球囊的近端处；
    止血Y阀，套接在所述管体之外，所述通路鞘管的近端与所述管体通过所述止血Y阀固定连接；
    穿过所述管体内腔的导引丝将所述双球囊导管推入血管内，将所述第一球囊推送至血管栓塞部位的远端，使所述第二球囊嵌入所述血管栓塞部位；通过所述第一接口向所述第一球囊内注入生理盐水，所述第一球囊膨胀并与血管内壁完全贴合，防止血栓逃逸；通过所述第二接口向所述第二球囊内注入溶栓药物，所述第二球囊内部产生压力，所述第二球囊表面的微孔张开，所述溶栓药物通过所述微孔释放至所述血管栓塞部位进行溶栓；通过所述止血Y阀向所述通路鞘管的内腔施加负压，将碎小的血栓吸出。
  2. 根据权利要求1所述的一种双球囊溶栓取栓装置，其特征在于，所述第一球囊内的所述管体上具有第一定位标记，所述第二球囊内的所述管体上具有第二定位标记，所述通路鞘管的远端的所述管体上具有第三定位标记。
  3. 根据权利要求1所述的一种双球囊溶栓取栓装置，其特征在于，所述第二球囊表面的微孔为压力响应型微孔，所述微孔的数量为2～10个，所 述微孔的直径为20～100微米。
  4. 根据权利要求1所述的一种双球囊溶栓取栓装置，其特征在于，所述第一球囊和第二球囊的间距为1～3cm；
    所述第一球囊为顺应性球囊，所述第一球囊的材质为硅胶或热塑性聚氨酯；
    所述第二球囊为顺应性球囊或半顺应性球囊，所述第二球囊的材质为硅胶、热塑性聚氨酯或嵌段聚醚酞胺聚合物。
  5. 根据权利要求1所述的一种双球囊溶栓取栓装置，其特征在于，所述管体的外径为1.8～3.2F，所述管体的内径为0.015～0.027英寸，所述管体的长度为140～160cm。
  6. 根据权利要求1所述的一种双球囊溶栓取栓装置，其特征在于，所述通路鞘管的外径为5～8F，所述通路鞘管的内径为0.058～0.088英寸，所述通路鞘管的长度为90～120cm。
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