WO2023093667A1 - 一种安全血栓取栓器 - Google Patents

一种安全血栓取栓器 Download PDF

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Publication number
WO2023093667A1
WO2023093667A1 PCT/CN2022/133202 CN2022133202W WO2023093667A1 WO 2023093667 A1 WO2023093667 A1 WO 2023093667A1 CN 2022133202 W CN2022133202 W CN 2022133202W WO 2023093667 A1 WO2023093667 A1 WO 2023093667A1
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Prior art keywords
thrombus
inner core
hollow
collector
handle
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PCT/CN2022/133202
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English (en)
French (fr)
Inventor
张学敏
吉训明
王涛
郑建良
李明
吴艳
陈冬冬
张旭志
Original Assignee
北京弘海微创科技有限公司
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Priority to DE112022005616.9T priority Critical patent/DE112022005616T5/de
Publication of WO2023093667A1 publication Critical patent/WO2023093667A1/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
    • A61B17/22—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
    • A61B17/221—Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/3205—Excision instruments
    • A61B17/3207—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
    • A61B17/320725—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions with radially expandable cutting or abrading elements
    • 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
    • A61B2017/22001—Angioplasty, e.g. PCTA
    • 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
    • A61B2017/22072—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 instrument channel, e.g. for replacing one instrument by the other
    • 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
    • A61B2017/22082—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 after introduction of a substance
    • 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
    • A61B2017/22082—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 after introduction of a substance
    • A61B2017/22084—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 after introduction of a substance stone- or thrombus-dissolving
    • 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
    • A61B17/221—Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions
    • A61B2017/2212—Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions having a closed distal end, e.g. a loop
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B2017/320056—Tunnelers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2217/00—General characteristics of surgical instruments
    • A61B2217/002—Auxiliary appliance
    • A61B2217/007—Auxiliary appliance with irrigation system

Definitions

  • the invention relates to a medical device, in particular to a device for crushing and collecting thrombus in human blood vessels and taking them out of the human body.
  • Thrombosis is a common disease of cardiovascular and cerebrovascular diseases in the human body, which is extremely harmful to human health.
  • the main treatment methods are drug-induced thrombus dissolution and removal of thrombus.
  • the thrombus breaker and thrombus collector set on the flexible multi-layered hose are inserted into the place where the thrombus forms in the human body through the blood vessel. After the pieces are collected, remove the human body.
  • the thrombus fragmentation and thrombus collection described above have two defects in long-term use. One is that there is air in the multi-layer hose of the thrombus retriever. When it is inserted into the human body, the air will enter the human body.
  • the blood vessels form air bubbles, and the air bubbles are essentially similar to thrombi. With the flow of blood, they randomly enter certain blood vessel positions and block the blood flow; If the collection efficiency of the thrombus collector is not high, the smaller thrombus clots escape the collection net of the thrombus collector, and may also enter the thinner blood vessels with the flow of blood to form new blockages that are more difficult to handle or treat, especially It is to enter the blood vessels of the brain and cause more serious consequences.
  • the above-mentioned two defects have existed for many years, and the above-mentioned two new blockages cannot be avoided even though doctors operate carefully. Therefore, how to solve the above-mentioned technical defects in the prior art and improve the safety of the thrombus retriever is still of great significance.
  • the purpose of the present invention is to provide a thrombus retriever with high safety.
  • a safe thrombus retriever of the present invention comprises: a handle; a hollow outer tube; a first inner core tube section located in the inner through hole of the outer tube, a second inner core tube section protruding from the front end of the outer tube, and a second inner core tube section extending from the rear of the outer tube.
  • the hollow inner core tube of the third inner core tube section protruding from the end; the thrombus breaker arranged at the front end of the outer tube; the thrombus collector connected to the front end of the second inner core tube section of the hollow inner core tube and located in front of the thrombus breaker;
  • the tee provided at the front end of the handle has a free end for injecting physiological saline; the adjusting button arranged on the handle and used to drive the outer tube to move forward and backward can be moved relative to the handle; the locking button arranged on the handle is used to After the outer tube moves to a predetermined position, the adjustment button is locked; the injector for injecting physiological saline is arranged on the third inner core tube segment of the hollow inner core tube exposed at the rear end of the handle.
  • the second inner core tube section of the hollow inner core tube protruding from the front end of the outer tube passes through the thrombus breaker and the thrombus collector in sequence, it is connected to the front end of the thrombus collector, so that before and after the adjustment button drives the outer tube Expand or tighten the thrombus disruptor and thrombus collector while moving.
  • the front end of the second inner core tube section of the hollow inner core tube is connected to the first hollow metal ring and connected to the front end of the thrombus collector via the first metal ring.
  • the outer tube is connected to the tee and is connected to the adjustment knob via the tee.
  • the adjusting button includes a first part disposed in the handle slide slot and a second part protruding from the front end of the handle and connected to the tee.
  • the front end of the thrombus breaker is connected to the rear end of the thrombus collector through a restraining ring.
  • the first hollow metal ring is connected to the hollow flexible introduction head in front of it.
  • the safety thrombus retriever of the present invention further includes a guide wire passing through the hollow lumen of the hollow inner core tube, the hollow lumen of the first hollow metal ring and the hollow lumen of the hollow flexible introduction head in sequence.
  • the free end of the tee is provided with a blocked end; the outer end of the injector is provided with a blocked end.
  • the front end of the thrombus collector is fixedly connected to the front end of the hollow inner core tube
  • the rear end of the thrombus breaker is connected to the front end of the outer tube
  • the rear end of the thrombus collector is connected to the front end of the thrombus breaker through a restraining ring. connect.
  • the diameter of the protruding ring is 0.5-2mm larger than the diameter of the rest of the collecting net.
  • the weaving density of the metal wires of the protruding ring is greater than that of the rest of the collecting net.
  • the thrombus breaker has a crushing mesh made of metal braided wires.
  • the structure of the crushing mesh is that the middle part is cylindrical, the two ends of the cylindrical shape are conical, and the weaving density of the conical part is 1-2mm.
  • a flat section that is close to the edge of the cylinder.
  • physiological saline is injected through the injector at the end of the tee and the end of the hollow inner core tube during use, and the space between the hollow inner core tube and the outer tube is The air in the space and the hollow through hole of the hollow inner core tube is discharged, and then it is inserted into the human body to crush, collect and take out the thrombus.
  • the specially designed thrombus collector can prevent the thrombus fragments from escaping, which greatly improves the performance of the present invention.
  • the safety of the thrombus retriever is high, and the safety hazards existing in the prior art are avoided.
  • Fig. 1 is the overall structure schematic diagram of an embodiment of the present invention
  • Fig. 2 is a diagram of the use state of the thrombus remover shown in Fig. 1;
  • Figure 3 is an enlarged schematic view of the handle
  • Figure 4 is an enlarged schematic view of a thrombus breaker and a thrombus collector
  • Fig. 5 is an enlarged schematic diagram of the connection structure of the handle, the inner tube, the thrombus breaker and the thrombus collector.
  • a safety thrombus retriever of the present invention includes: a hollow outer tube 2; The hollow inner core tube 3 of the second inner core tube section and the third inner core tube section protruding from the rear end of the outer tube 2; the thrombus breaker 5 arranged at the front end of the outer tube 2; the front end of the second inner core tube section is connected and located at the thrombus breaker 5
  • the thrombus collector 4 in front; the tee 6 arranged at the front end of the handle 1 has a free end 10 for injecting physiological saline; the device arranged on the handle 1 that can move relative to the handle 1 is used to drive the outer tube 2 to move back and forth
  • the adjusting button 7; the locking button 8 arranged on the handle 1 is used to lock the adjusting button 7 after the outer tube 2 moves to a predetermined position;
  • An injector 9 for injecting physiological saline.
  • the second inner core tube section of the hollow inner core tube 3 protruding from the front end of the outer tube 2 passes through the thrombus breaker 5 and the thrombus collector 4 sequentially and then connects to the front end of the thrombus collector 4 ,
  • the front end of the second inner core tube section of the hollow inner core tube 3 is connected to the first hollow metal ring 16 and connected to the front end of the thrombus collector 4 via the first metal ring 16 .
  • the outer tube 2 is connected to a tee 6 and is connected to an adjustment knob 7 via the tee 6 .
  • the adjusting button 7 includes a first part disposed in the chute of the handle 1 and a second part protruding from the front end of the handle 1 and connected to the tee 6 .
  • the front end of the thrombus breaker 5 is connected to the rear end of the thrombus collector 4 through a restraint ring 18, so that when the outer tube (2) moves back and forth, the thrombus breaker 5 and the thrombus collector 4 can be linked.
  • the present invention also has a hollow flexible introduction head 15 connected with the first hollow metal ring 16, so that a guide wire (not shown) for crushing thrombus can pass through the hollow inner core tube in turn if necessary (3)
  • the hollow inner cavity, the hollow inner cavity of the first hollow metal ring (16) and the hollow flexible introduction head (15) protrude after the hollow inner cavity.
  • the front end of the handle 1 is provided with a tee 6, and the straight pipe of the tee 6 is provided with an outer tube 2 and a hollow inner core tube 3, and the rear end of the third inner core tube section of the hollow inner core tube 3 is fixedly connected to the handle with the injector 9 1 rear end.
  • the adjusting button 7 on the handle 1 controls and adjusts the front and rear movement displacement of the outer tube 2 and the hollow inner core tube 3, and the locking button 8 can tighten the adjusting button 7 on the handle 1.
  • physiological saline is injected through a free end 10 of the tee 6 and the injector 9, and the physiological saline closes the gap between the outer tube 2 and the hollow inner core tube 3 and the hollow inner core tube.
  • a sealing ring 14 is provided at the connection between the tee 6 and the adjustment button 7 to prevent the normal saline from leaking out, and then it is placed in the blood vessel of the human body, and then through normal operation, the thrombus collector 4 and The thrombus breaker 5 unfolds along with the displacement of the outer tube 2, and is delivered to the thrombus position in the blood vessel to crush and collect the thrombus.
  • the air in the hollow inner cavity of the core tube 3 has been discharged in advance, which prevents the possibility of air entering the blood vessels of the human body, completely avoids the possibility of new blood vessel blockages caused by air bubbles entering the blood vessels of the human body, and greatly improves the safety of thrombus extraction sex.
  • the free end 10 of the tee 6 is provided with a blocking end, or/and the outer end of the injector 9 is provided with a blocking end (the blocking end is not shown in the figure) , the above-mentioned blocked end can close the opening of the free end 10 and the injection port of the injector 9 after injecting physiological saline into the thrombus retriever, so as to avoid the escape of the physiological saline and the re-entry of air that may exist when the thrombus retriever is repeatedly operated.
  • the gap between the outer tube 2 and the hollow inner core tube 3 and the hollow inner cavity of the hollow inner core tube 3 ensure the safety of the thrombus extraction process.
  • the front end of the thrombus collector 4 is provided with a flexible introduction head 15 and a first metal ring 16, the flexible introduction head 15 is connected to the first metal ring 16, and the first metal ring 16 is fixedly connected to the front end of the hollow inner core tube 3; the thrombus
  • the rear end of the breaker 5 is connected to the front end of the outer tube 2 and the second metal ring 17, and the rear end of the thrombus collector 4 is connected to the front end of the thrombus breaker 5 through a confinement ring 18, and the confinement ring 18 can be along the hollow inner core
  • the tube 3 is displaced; the outer tube 2 is displaced by the adjustment button 7, and the thrombus breaker 5 and the thrombus collector 4 are released (opened) or contracted, depending on the thickness of the blood vessels of the human body.
  • the thrombus collector 4 and the thrombus breaker 5 are each provided with at least three developing rings 13, and the developing rings 13 are made of materials that can be developed under X-ray irradiation, so that the thrombus collector 4 and thrombus When the breaker 5 is inserted into the blood vessels of the human body, the actual opening and contraction states of the thrombus collector 4 and the thrombus breaker 5 can be clearly observed.
  • the hollow inner core tube 3 can pass through the hollow cavity of the first metal ring 16 and the flexible introduction head 15 in turn, and at least be fixedly connected to the first metal ring 16, so as to shrink or shrink as shown in FIG. 1
  • the tight thrombus collector 4 and the thrombus breaker 5 cannot pass through the thrombus, utilize a guide wire (not shown) passing through the hollow lumen of the hollow inner core tube 3 to destroy the thrombus so that the thrombus collector 4 and the thrombus collector 4 that shrink or tighten
  • the thrombus breaker 5 passes through blood vessels with thrombus.
  • the thrombus breaker 5 undergoes axial displacement and rotation, and the metal braided mesh of the thrombus breaker 5 cuts the thrombus axially and radially, and the thrombus blocks formed by cutting are collected by the collecting net of the thrombus collector 4 , when the thrombus is broken, it is necessary to repeatedly move the thrombus collector 4 and the thrombus breaker 5 axially and/or rotationally, so that the collection net of the thrombus collector 4 moves and causes the collection net to deform, and this deformation may cause the collection net to be in contact with the vessel wall.
  • the broken thrombus enters the blood circulation of the blood vessel through the gap, and then new and smaller blood vessels are blocked.
  • the protruding ring 11 When the collection net is in the When axial displacement or rotation produces overall deformation, the protruding ring 11 has a greater amount of radial deformation, so that the protruding ring 11 can maintain proper contact with the blood vessel wall, avoiding the above-mentioned gap, and further avoiding the broken thrombus block from being redistributed. Entering the blood circulation, further improving the safety of the thrombus retriever.
  • the braiding density of the metal wires of the above-mentioned protruding ring 11 of the collecting net is greater than that of the rest of the collecting net, further appropriately improving the radial elasticity of the protruding ring 11, avoiding the above-mentioned gaps, and collecting nets
  • the thrombus breaker 5 has a crushing net made of metal braided wire.
  • the structure of the crushing net is that the middle part is cylindrical, and the two ends of the cylindrical shape are conical (see Fig. 4 and Fig. 5), and the weaving of the conical part
  • the thread can cut the thrombus in the axial direction, and the braided thread of the cylindrical part mainly cuts the thrombus in the radial direction.
  • the segment 12 is close to the edge of the cylinder, and the flat segment 12 has a better cutting effect on thrombus than the conventionally used circular braided wire. The deformation produces hindrance.

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Abstract

一种安全血栓取栓器，包括：手柄(1)；中空的外管(2)；具有位于外管(2)内通孔中的第一内芯管段、从外管(2)前端伸出的第二内芯管段以及从外管(2)后端伸出的第三内芯管段的中空内芯管(3)；设置在外管(2)前端的血栓破碎器(5)；连接中空内芯管(3)第二内芯管段前端且位于血栓破碎器(5)前方的血栓收集器(4)；设置在手柄(1)前端的三通(6)，具有用于注入生理盐水的自由端(10)；设置在手柄(1)上的可相对于手柄(1)移动的用于驱动外管(2)前后移动的调节钮(7)；设置在手柄(1)上的锁紧钮(8)，用于在外管(2)移动到预定位置后锁紧调节钮(7)；设置在外露于手柄(1)后端的中空内芯管(3)第三内芯管段上的用于注入生理盐水的注入器(9)。

Description

一种安全血栓取栓器 技术领域
本发明涉及一种医疗器械,具体是涉及一种将人体血管内的血栓破碎并收集而取出人体的器械。
背景技术
血栓形成是目前人体的心脑血管的常发病症,对人体的健康具有极大的危害性,治疗方法主要是药性溶拴和取出血栓,目前常用的取出血栓的方法是通过介入治疗,即将一设在可伸缩的多层套装软管上的血栓破碎器和血栓收集器经血管置入人体血栓形成的位置,由血栓破碎器将血栓破碎成较小的血栓块,再由血栓收集器将血栓块收集后,取出人体。上述的血栓破碎与血栓收集的取栓器,在长期的使用中存在两个缺陷,一是取栓器的多层套装软管中存在空气,置入人体后的操作时,会使空气进入人体血管形成气泡,而气泡实质上就类似于血栓,随着血液的流动,随机进入某些血管位置而对血液的流动形成堵塞；二是血栓破碎器将血栓破碎过程中存在较小的血栓块,如血栓收集器的收集效率不高,使较小的血栓块逸出血栓收集器的收集网,同样会随着血液的流动可能进入较细的血管形成更难处理或治疗的新的堵塞,特别是进入脑部血管而造成更为严重的后果。上述的两个缺陷已存在多年,尽管医生小心操作仍无法避免上述的两种新的堵塞,因此如何解决现有技术存在的上述的技术缺陷,提高血栓取栓器的安全性仍具有重要意义。
发明内容
本发明的发明目的是提供一种安全性高的血栓取栓器。
本发明的一种安全血栓取栓器包括：手柄；中空的外管；具有位于外管内通孔中的第一内芯管段、从外管前端伸出的第二内芯管段以及从外管后端伸出的第三内芯管段的中空内芯管；设置在外管前端的血栓破碎器；连接所述中空内芯管第二内芯管段前端且位于所述血栓破碎器前方的血栓收集器；设置在手柄前端的三通，具有用于注入生理盐水的自由端；设置在手柄上的可相对于手柄移动的用于驱动外管前后移动的调节钮；设置在手柄上的锁紧钮,用于在外管移动到预定位置后锁紧所述调节钮；设置在外露于手柄后端的中空内芯管第三内芯管段上的用于注入生理盐水的注入器。
优选地，从所述外管前端伸出的中空内芯管第二内芯管段依次穿过血栓破碎器和血 栓收集器后，连接所述血栓收集器的前端，以便在调节钮驱动外管前后移动时，使血栓破碎器和血栓收集器张开或收紧。
优选地，所述中空内芯管第二内芯管段的前端连接第一中空金属环并经由所述第一金属环连接血栓收集器的前端。
优选地，所述外管连接所述三通并经由所述三通连接所述调节钮。
优选地，所述调节钮包括设置在手柄滑槽内的第一部分和从手柄前端伸出且连接所述三通的第二部分。
优选地，所述血栓破碎器的前端与所述血栓收集器的后端通过约束环连接。
优选地，第一中空金属环与其前方的中空柔性导入头连接。
优选地，本发明的安全血栓取栓器还包括依次穿过中空内芯管中空内腔、第一中空金属环中空内腔和中空柔性导入头中空内腔的导丝。
优选地，所述的三通的自由端设有封堵端；所述的注入器的外端部设有封堵端。
优选地，所述的血栓收集器的前端与中空内芯管的前端固定连接，血栓破碎器的后端与外管的前端连接，血栓收集器的后端经一约束环与血栓破碎器的前端连接。
优选地，所述的血栓收集器的收集网的轴向中部位置有至少一个凸环,凸环的直径大于收集网的其余部分的直径0.5-2mm。
优选地，所述的凸环的金属丝的编织密度大于收集网的其余部分的编织密度。
优选地，所述的血栓收集器的收集网上的凸环为两个。
优选地，所述的血栓破碎器有一金属编织丝构成的破碎网，该破碎网的结构是中间部分为圆柱形，圆柱形的两端为椎形，椎形部分的编织密度有一1～2mm的扁平段，该扁平段接近圆柱形的边缘处。
本发明的上述的技术方案限定的血栓取栓器,在使用时通过所述的三通的端部和中空内芯管的端部的注入器注入生理盐水,将中空内芯管与外管之间和中空内芯管的中空通孔中的空气排出,然后再置入人体对血栓进行破碎、收集和取出,同时特定设计的血栓收集器可避免血栓碎块逸出,大幅度提高了本发明的血栓取栓器的安全性,避免了现有技术存在的安全隐患。
附图说明
图1为本发明的一个实施例的整体结构示意图；
图2为图1所示取栓器的使用状态图；
图3为手柄的放大示意图；
图4为血栓破碎器和血栓收集器的放大示意图；
图5为手柄和内心管与血栓破碎器和血栓收集器连接结构的放大示意图。
具体实施方式
结合附图给出本发明的具体实施方式的详细描述，需要说明的是对本发明的详细描述是为便于对发明的技术实质的了解，而不应视为是对本发明的权利要求保护范围的限制。
请参见图1-5，本发明的一种安全血栓取栓器包括：中空的外管2；具有位于外管2内通孔中的第一内芯管段、从外管2前端伸出的第二内芯管段以及从外管2后端伸出的第三内芯管段的中空内芯管3；设置在外管2前端的血栓破碎器5；连接第二内芯管段前端且位于血栓破碎器5前方的血栓收集器4；设置在手柄1前端的三通6，具有用于注入生理盐水的自由端10；设置在手柄1上的可相对于手柄1移动的用于驱动外管2前后移动的调节钮7；设置在手柄1上的锁紧钮8,用于在外管2移动到预定位置后锁紧所述调节钮7；设置在外露于手柄1后端的第三内芯管段上的用于注入生理盐水的注入器9。
如图5所示，从所述外管2前端伸出的中空内芯管3的第二内芯管段依次穿过血栓破碎器5和血栓收集器4后连接所述血栓收集器4的前端，以便在调节钮7驱动外管2前后移动时，使血栓破碎器5和血栓收集器4张开(如图2所示)或收紧(如图1所示)。中空内芯管3的第二内芯管段的前端连接第一中空金属环16并经由所述第一金属环16连接血栓收集器4的前端。
如图1至图3所示，外管2连接三通6并经由三通6连接调节钮7。如图3所示，调节钮7包括设置在手柄1滑槽内的第一部分和从手柄1前端伸出且连接三通6的第二部分。
如图5所示，血栓破碎器5的前端与血栓收集器4的后端通过一个约束环18连接，以便在外管(2)前后移动时，能够使血栓破碎器5和血栓收集器4联动。
如图5所示，本发明还具有与第一中空金属环16连接的中空柔性导入头15，以便必要时使得一个用于破碎血栓的导丝(图中未显示)依次穿过中空内芯管(3)中空内腔、第一中空金属环(16)中空内腔和中空柔性导入头(15)中空内腔后伸出。
具体地说。中空内芯管3和外管2之间有间隙，使得外管2可相对于空内芯管3移动。手柄1的前端设有三通6,三通6的直通管中设有外管2和中空内芯管3,中空内芯管3的第三内芯管段的后端与注入器9固接于手柄1后端部。在手柄1上的调节钮7控制调节外管2和中空内芯管3的前后运动位移,锁紧钮8可以将调节钮7缩紧在手柄 1上。在将上述的血栓取栓器置入人体血管前,通过三通6的一个自由端10和注入器9注入生理盐水,生理盐水将外管2和中空内芯管3的间隙和中空内芯管3的中空通道中的空气排出,同时在三通6与调节钮7连接处设有密封圈14防止生理盐水外泄，然后再置入人体血管内,再通过正常操作,使血栓收集器4和血栓破碎器5随着外管2的位移而展开,并送达血管内的血栓位置进行破碎和收集血栓操作,在整个操作过程中,由于外管2与中空内芯管3之间和中空内芯管3中空内腔的空气已事先排出,杜绝了空气进入人体血管内的可能,彻底避免了因空气气泡进入人体血管而形成新的血管内堵塞的可能,大幅度地提高了取血栓的安全性。
为进一步提高安全性,所述的三通6的自由端10设有封堵端,或/和所述的注入器9的外端部设有封堵端(图中未示出封堵端),上述的封堵端在对取栓器注入生理盐水后可将自由端10的开口和注入器9的注入口封闭,避免生理盐水逸出,和反复操作取栓器时可能存在的空气再次进入外管2与中空内芯管3之间的间隙和中空内芯管3的中空内腔,确保取血栓过程的安全性。
所述的血栓收集器4的前端设有柔性导入头15和第一金属环16，柔性导入头15连接第一金属环16,第一金属环16与中空内芯管3的前端固定连接；血栓破碎器5的后端与外管2的前端和第二金属环17连接，血栓收集器4的后端经一约束环18与血栓破碎器5的前端连接，约束环18可沿着中空内芯管3位移；通过调节钮7使外管2位移,释放(张开)或收缩血栓破碎器5和血栓收集器4,视人体血管的粗细在监视下,当血栓破碎器5和血栓收集器4与血管的直径相适应后,旋动锁紧钮8,使外管2不能再轴向位移,即可进行破碎血栓的操作,上述的血栓收集器4和血栓破碎器5的联动,可更好控制释放的程度和方便操作。
为提高显影性，在血栓收集器4和血栓破碎器5各自设有至少3个以上显影环13，显影环13由能够在X射线照射下显影的材料制成，以便在血栓收集器4和血栓破碎器5置入人体血管过程中，能清晰地观察血栓收集器4和血栓破碎器5的实际张开与收缩状态。
在另一个实例中，中空内芯管3可依次穿过第一金属环16和柔性导入头15的中空腔，并至少固定连接第一金属环16，以便在如图1所示的收缩或缩紧的血栓收集器4和血栓破碎器5不能通过血栓时，利用穿过中空内芯管3中空内腔的导丝(图中未显示)破坏血栓，以便收缩或缩紧的血栓收集器4和血栓破碎器5通过具有血栓的血管。
在实际使用过程中,血栓破碎器5经过轴向位移和旋转,血栓破碎器5的金属编织网对血栓进行轴向和径向切割,被切割形成的血栓块被血栓收集器4的收集网收集,由于破碎血栓时,需要反复使血栓收集器4和血栓破碎器5轴向和/或旋转运动,使血栓收集器4的收集网运动而导致收集网变形,该变形可能导致收集网与血管壁面之间产生间隙,出现破碎的血栓块通过上述间隙而进入血管的血液循环,进而产生新的更小的血管的堵塞。为避免上述间隙的产生,所述的血栓收集器4的收集网的轴向中部位置有至少一个凸环11,该凸环11的直径大于收集网的其余部分的直径0.5-2mm；由于收集网是由金属丝编织构成,收集网在径向具有一定的弹性,当收集网在人体血管中时,凸环11的弹性变形和受到的弹力较之收集网的其余部分较大,当收集网在轴向位移或旋转产生整体变形时,凸环11具有更大的径向变形量,使凸环11与血管壁面保持适当的接触,避免了上述的间隙的产生,进而避免了破碎的血栓块重新进入血液循环,进一步提高了血栓取栓器的安全性。
为进一步提高安全性,收集网的上述凸环11的金属丝的编织密度大于收集网的其余部分的编织密度,进一步适当提高了凸环11径向弹性,避免上述的间隙的产生,并且收集网上的凸环11为两个,进一步提高凸环11的封堵效果。
所述的血栓破碎器5有一金属编织丝构成的破碎网，该破碎网的结构是中间部分为圆柱形，圆柱形的两端为椎形(参见图4和图5)，椎形部分的编织丝起到对血栓的轴向切割,圆柱形部分的编织丝主要对血栓进行径向切割,为提高对血栓的轴向切割,椎形部分的编织密度有一1～2mm的扁平段12，该扁平段12接近圆柱形的边缘处,扁平段12较之常规使用的圆形编织丝有更好的对血栓的切割效果,同时扁平段12长度限定在1～2mm，又不会对编织丝的整体的变形产生阻碍作用。
尽管上文对本发明进行了详细说明，但是本发明不限于此，本技术领域技术人员可以根据本发明的原理进行各种修改。因此，凡按照本发明原理所作的修改，都应当理解为落入本发明的保护范围。

Claims (15)

  1. 一种安全血栓取栓器，其特征在于包括：
    手柄(1)；
    中空的外管(2)；
    具有位于外管(2)内通孔中的第一内芯管段、从外管(2)前端伸出的第二内芯管段以及从外管(2)后端伸出的第三内芯管段的中空内芯管(3)；
    设置在外管(2)前端的血栓破碎器(5)；
    连接所述中空内芯管(3)第二内芯管段前端且位于所述血栓破碎器(5)前方的血栓收集器(4)；
    设置在手柄(1)前端的三通(6)，具有用于注入生理盐水的自由端(10)；
    设置在手柄(1)上的可相对于手柄(1)移动的用于驱动外管(2)前后移动的调节钮(7)；
    设置在手柄(1)上的锁紧钮(8),用于在外管(2)移动到预定位置后锁紧所述调节钮(7)；
    设置在外露于手柄(1)后端的中空内芯管(3)第三内芯管段上的用于注入生理盐水的注入器(9)。
  2. 按权利要求1所述的安全血栓取栓器，其特征在于，从所述外管(2)前端伸出的中空内芯管(3)第二内芯管段依次穿过血栓破碎器(5)和血栓收集器(4)后，连接所述血栓收集器(4)的前端，以便在调节钮(7)驱动外管(2)前后移动时，使血栓破碎器(5)和血栓收集器(4)张开或收紧。
  3. 按权利要求2所述的安全血栓取栓器，其特征在于，所述中空内芯管(3)第二内芯管段的前端连接第一中空金属环(16)并经由所述第一金属环(16)连接血栓收集器(4)的前端。
  4. 按权利要求2所述的安全血栓取栓器，其特征在于，所述外管(2)连接所述三通(6)并经由所述三通(6)连接所述调节钮(7)。
  5. 按权利要求4所述的安全血栓取栓器，其特征在于，所述调节钮(7)包括设置在手柄(1)滑槽内的第一部分和从手柄(1)前端伸出且连接所述三通(6)的第二部分。
  6. 按权利要求2所述的安全血栓取栓器，其特征在于，所述血栓破碎器(5)的前端与所述血栓收集器(4)的后端通过约束环(18)连接。
  7. 按权利要求3所述的安全血栓取栓器，其特征在于，第一中空金属环(16)与其前方的中空柔性导入头(15)连接。
  8. 按权利要求7所述的安全血栓取栓器，其特征在于还包括依次穿过中空内芯管(3)中空内腔、第一中空金属环(16)中空内腔和中空柔性导入头(15)中空内腔的导丝。
  9. 按权利要求1所述的安全血栓取栓器，其特征在于所述的三通(6)的自由端(10)设有封堵端。
  10. 按权利要求1或9所述的安全血栓取栓器，其特征在于所述的注入器(9)的外端部设有封堵端。
  11. 按权利要求10所述的安全血栓取栓器，其特征在于所述的血栓收集器(4)的前端与中空内芯管(3)的前端固定连接，血栓破碎器(5)的后端与外管(2)的前端连接，血栓收集器(4)的后端经一约束环与血栓破碎器(5)的前端连接，血栓收集器(4)和血栓破碎器(5)分别设有显影环(13)。
  12. 按权利要求11所述的安全血栓取栓器，其特征在于所述的血栓收集器(4)的收集网的轴向中部位置有至少一个凸环(11),凸环(11)的直径大于收集网的其余部分的直径0.5-2mm。
  13. 按权利要求12所述的安全血栓取栓器，其特征在于所述的凸环(11)的金属丝的编织密度大于收集网的其余部分的编织密度。
  14. 按权利要求13所述的安全血栓取栓器，其特征在于所述的血栓收集器(4)的收集网上的凸环(11)为两个。
  15. 按权利要求15所述的安全血栓取栓器，其特征在于所述的血栓破碎器(5)有一金属编织丝构成的破碎网，该破碎网的结构是中间部分为圆柱形，圆柱形的两端为椎形，椎形部分的编织密度有一1～2mm的扁平段(12)，该扁平段(12)接近圆柱形的边缘处。
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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN117204918A (zh) * 2023-11-08 2023-12-12 北京久事神康医疗科技有限公司 一种取栓装置
CN117204918B (zh) * 2023-11-08 2024-02-23 北京久事神康医疗科技有限公司 一种取栓装置

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