CN108143464A - Thrombectomy Catheter and Thrombectomy for Thrombectomy Catheter - Google Patents
Thrombectomy Catheter and Thrombectomy for Thrombectomy Catheter Download PDFInfo
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
- A61B2017/22038—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for with a guide wire
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
- A61B2017/22051—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; 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 inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; 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
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
- A61B2017/22051—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; 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
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- A61B17/00—Surgical instruments, devices or methods
- A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
- A61B2017/22079—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for with suction of debris
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61B17/00—Surgical instruments, devices or methods
- A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
- A61B2017/22082—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for after introduction of a substance
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Abstract
Description
技术领域technical field
本发明涉及一种取栓技术领域,特别是涉及一种取栓导管以及用于取栓导管的取栓器。The invention relates to the technical field of thrombectomy, in particular to a thrombus retrieval catheter and a thrombus retriever used for the thrombus retrieval catheter.
背景技术Background technique
血栓栓塞性疾病包括动脉栓塞、动脉血栓形成以及静脉血栓栓塞症,现有的治疗方法主要包括血管切开取栓术、导管接触性溶栓术和经皮穿刺机械吸栓术,切开取栓术需要解剖分离并切开血管,如股动脉、股静脉或肱动脉切开等,随着腔内介入技术的发展和材料的革新,这一开放性手术方式逐步被微创介入腔内治疗取代,也就是导管接触性溶栓术和经皮穿刺机械吸栓术,导管接触性溶栓术由于溶栓药物出血风险高,手术适应症极其严格,很大一部分患者具有导管接触性溶栓的禁忌症,因此很多患者并不能从中获益。Thromboembolic diseases include arterial embolism, arterial thrombosis, and venous thromboembolism. Existing treatments mainly include angiotomy, catheter-based thrombolysis, and percutaneous mechanical thrombectomy. Surgery requires anatomical separation and incision of blood vessels, such as femoral artery, femoral vein or brachial artery incision, etc. With the development of endovascular interventional technology and the innovation of materials, this open surgical method is gradually replaced by minimally invasive interventional endovascular treatment , that is, catheter-based thrombolysis and percutaneous mechanical embolectomy. Catheter-based thrombolysis has a high risk of thrombolytic drug bleeding, and the surgical indications are extremely strict. A large number of patients have contraindications for catheter-based thrombolysis. disease, so many patients do not benefit from it.
支架型取栓术是新近出现的一种机械取栓方法,这种方法即是在医疗影像学技术的辅助下,经导管将支架型取栓器送至血管栓塞处并令其释放,支架型取栓器自行展开,并依靠自身的扩张力与血栓嵌合,然后回收取栓器,将血栓带出。Stent-type thrombectomy is a newly emerged mechanical thrombectomy method. This method is to send a stent-type thrombectomy device to the vascular embolism through the catheter and release it with the assistance of medical imaging technology. The thrombus retriever expands by itself, and relies on its own expansion force to engage with the thrombus, and then retracts the thrombus retriever to take out the thrombus.
中国发明专利CN103417257B公开了一种颅内血管取栓导管,该取栓导管的螺旋形网环单元的分布密度不同,远端分布较密,而近端分布则相对稀疏,可以有效防止小血栓脱落。中国发明专利CN103997976A公开了一种具有细长轴线和圆周的取栓笼,包括共同限定多个开放单元的细长构件,该取栓笼可以有效的移除栓塞。中国发明专利CN105726088A公开了一种血栓取出装置,包括网状的自膨式的支架和芯丝,支架膨胀状态为圆筒形,近端具有开口,远端封闭,该血栓取出装置可将血栓均匀嵌挂于支架轴向网孔,产生的血栓碎片通过支架近端开口进入其内部,并被封闭的远端收集。Chinese invention patent CN103417257B discloses a catheter for intracranial vascular thrombus removal. The distribution density of the spiral mesh ring units of the catheter is different. The distal end is denser, while the proximal end is relatively sparse, which can effectively prevent small thrombus from falling off. . Chinese invention patent CN103997976A discloses a thrombectomy cage with an elongated axis and a circumference, including elongated members jointly defining a plurality of open cells, and the thrombectomy cage can effectively remove emboli. Chinese invention patent CN105726088A discloses a thrombus removal device, which includes a net-shaped self-expanding stent and a core wire. The expanded state of the stent is cylindrical, with an opening at the proximal end and a closed distal end. Embedded in the axial mesh of the stent, the generated thrombus fragments enter the interior through the proximal opening of the stent and are collected by the closed distal end.
如上所述,目前的支架型取栓器或取栓导管由于结构所限,单纯采用稀疏支架杆抓捕血栓或负压抽吸的方式,并拉动血栓将血栓带出体外,但是在取栓时,支架型取栓器或取栓导管作用在血栓上的力不均匀,血栓容易从取栓器上脱落,或是产生血栓碎块堵塞远端血管,或者进入其他血管处,长时间的负压也会导致失血量过多。另外,目前的支架型取栓器或取栓导管对于对陈旧性血栓以及大范围栓塞效果不佳。基于已有医学认知,深静脉血栓形成往往容量大,急性期血栓质感柔软易碎;动脉血栓形成往往容量小,急性期血栓质感柔软,陈旧性血栓往往粘附在血管壁上。目前稀疏结构的支架型取栓导管通常是针对动脉血栓而开发,对于大容量静脉血栓形成往往效果不理想。因此,需要一种易于取栓的取栓导管。As mentioned above, the current stent-type thrombus retriever or thrombus retrieval catheter is limited by its structure. It simply uses sparse stent rods to capture the thrombus or negative pressure suction, and pulls the thrombus to take the thrombus out of the body. , The force of the stent-type thrombus retriever or thrombus retrieval catheter on the thrombus is not uniform, the thrombus is easy to fall off from the thrombus retriever, or thrombus fragments are generated to block the distal blood vessel, or enter other blood vessels, long-term negative pressure It can also cause excessive blood loss. In addition, the current stent-type thrombus retriever or thrombus retrieval catheter is not effective for old thrombus and large-scale embolism. Based on existing medical knowledge, deep vein thrombosis often has a large volume, and the thrombus in the acute phase is soft and fragile; arterial thrombosis often has a small volume, and the thrombus in the acute phase has a soft texture, and old thrombus often adheres to the vessel wall. At present, the stent-type embolectomy catheter with sparse structure is usually developed for arterial thrombosis, and the effect is often not ideal for large-volume venous thrombosis. Therefore, there is a need for a thrombectomy catheter that is easy to remove the thrombus.
发明内容Contents of the invention
鉴于以上所述现有技术的缺点,本发明的目的在于提供一种取栓导管以及用于取栓导管的取栓器,用于解决现有技术中支架取栓器使用时血栓脱落外溢及失血过多的问题。In view of the above-mentioned shortcomings of the prior art, the object of the present invention is to provide a thrombus retrieval catheter and a thrombus retriever for the thrombus retrieval catheter, which are used to solve the problem of thrombus shedding, spillage and blood loss when the stent retriever is used in the prior art. Too many questions.
为实现上述目的及其他相关目的,本发明提供一种取栓导管,其包括:In order to achieve the above purpose and other related purposes, the present invention provides a thrombectomy catheter, which includes:
阻断鞘,包括鞘管,鞘管的远端设有球囊,鞘管的近端连设手柄,且鞘管内设有至少两个轴向延伸的腔体,第一腔体的远端与所述球囊的内腔相通,第一腔体的近端与连设在手柄上的球囊充盈接头相通,在球囊侧的所述鞘管上设有显影标记;第二腔体的近端与连设在手柄上的负压抽吸装置相连通,并且所述手柄上还设有与所述第二腔体轴向相通的开口部;The blocking sheath includes a sheath tube, the distal end of the sheath tube is provided with a balloon, the proximal end of the sheath tube is connected with a handle, and at least two axially extending cavities are arranged in the sheath tube, the distal end of the first cavity is connected to the The inner cavity of the balloon communicates, the proximal end of the first cavity communicates with the balloon filling joint connected to the handle, and a developing mark is provided on the sheath on the side of the balloon; the proximal end of the second cavity The end communicates with the negative pressure suction device connected to the handle, and the handle is also provided with an opening in axial communication with the second cavity;
扩张器,扩张器的外径与所述鞘管的第二腔体内径匹配,可从所述手柄的开口部伸入所述鞘管的第二腔体内,扩张器的远端从所述鞘管的第二腔体内穿出并且将所述鞘管的第二腔体封堵;A dilator, the outer diameter of the dilator matches the inner diameter of the second cavity of the sheath, and can be inserted into the second cavity of the sheath from the opening of the handle, and the distal end of the dilator passes through the sheath passing through the second lumen of the tube and blocking the second lumen of the sheath;
取栓器,包括同轴套设的外管和内管,以及可膨胀的密网状取栓件,且内管的两端均外露于外管的两端之外,且内管可相对外管沿轴向移动也可相互定位不动,密网状取栓件一端与内管的远端相连,密网状取栓件另一端与外管的远端相连,抽拉内管可使密网状取栓件膨胀或松弛;取栓器可从所述手柄的开口部伸入所述第二腔体内,且外管的远端从所述第二腔体内穿出,外管的近端外露于所述手柄的开口部的外侧。A thrombus retriever, including an outer tube and an inner tube coaxially sleeved, and an expandable mesh-shaped thrombus remover, and both ends of the inner tube are exposed outside the two ends of the outer tube, and the inner tube can be opposite to the outer tube. The tubes can move axially and can also be fixed with each other. One end of the dense mesh plug-retrieving part is connected with the distal end of the inner tube, and the other end of the dense-net-shaped plug-removing part is connected with the distal end of the outer tube. Pulling the inner tube can make the tight The mesh thrombus remover expands or relaxes; the thrombus remover can extend into the second cavity from the opening of the handle, and the distal end of the outer tube passes through the second cavity, and the proximal end of the outer tube exposed outside the opening of the handle.
优选的,所述手柄的开口部处设有连接卡扣,所述扩张器的近端连设一手持部,手持部上设有与所述连接卡扣配合固定的连接部。Preferably, a connection buckle is provided at the opening of the handle, a handle is provided at the proximal end of the dilator, and a connection part is provided on the handle to fit and fix with the connection buckle.
优选的,所述球囊材质为天然乳胶、合成橡胶、硅胶或聚氨酯等热塑性弹性体。Preferably, the material of the balloon is thermoplastic elastomer such as natural latex, synthetic rubber, silica gel or polyurethane.
优选的,所述密网状取栓件由超弹记忆镍钛合金丝混合铂铱合金丝、黄金丝或不锈钢丝编织而成,铂铱合金丝、黄金丝或不锈钢丝用于X光机下显影。Preferably, the dense mesh-shaped bolt-removing member is braided by superelastic memory nickel-titanium alloy wire mixed with platinum-iridium alloy wire, gold wire or stainless steel wire, and the platinum-iridium alloy wire, gold wire or stainless steel wire are used under X-ray machines. development.
优选的,所述外管的近端连设一手持件,且所述手持件上设有锁定所述内管的定位部。Preferably, a handpiece is connected to the proximal end of the outer tube, and the handpiece is provided with a positioning part for locking the inner tube.
优选的,所述内管的近端连设有抽拉手柄。Preferably, a pull handle is connected to the proximal end of the inner tube.
优选的,所述鞘管、所述内管和所述外管均采用聚酰胺类热塑性弹性体制成。Preferably, the sheath tube, the inner tube and the outer tube are all made of polyamide thermoplastic elastomer.
优选的,所述扩张器采用热塑性弹性体制成,且热塑性弹性体内填充有含显影剂材质硫酸钡、氧化铋或氯氧化铋。Preferably, the dilator is made of thermoplastic elastomer, and the thermoplastic elastomer is filled with barium sulfate, bismuth oxide or bismuth oxychloride containing developer material.
优选的,所述鞘管、所述内管的远端为锥形。Preferably, the distal ends of the sheath and the inner tube are tapered.
本发明还提供一种用于取栓导管的取栓器,所述取栓器包括同轴套设的外管和内管,以及可膨胀的密网状取栓件,且内管的两端均外露于外管的两端之外且内管可相对外管沿轴向移动,密网状取栓件一端与内管的远端相连,密网状取栓件另一端与外管的远端相连,抽拉内管可使密网状取栓件膨胀或松弛。The present invention also provides a thrombus retriever for a thrombectomy catheter. The thrombus retriever includes an outer tube and an inner tube that are coaxially sleeved, and an expandable dense mesh thrombus remover, and the two ends of the inner tube Both ends are exposed outside the two ends of the outer tube, and the inner tube can move axially relative to the outer tube. One end of the dense mesh bolt-removing part is connected with the distal end of the inner pipe, and the other end of the dense mesh-shaped bolt-removing part is connected to the distal end of the outer pipe. The end is connected, and the inner tube can be pulled to expand or relax the dense mesh thrombus retrieval device.
优选的,所述密网状取栓件由超弹记忆镍钛合金丝中混合铂铱合金丝、黄金丝或不锈钢丝编织而成。Preferably, the dense mesh-shaped bolt-removing member is braided by mixing platinum-iridium alloy wire, gold wire or stainless steel wire in superelastic memory nickel-titanium alloy wire.
优选的,所述外管的近端连设一手持件,且所述手持件上设有锁定所述内管的定位部。Preferably, a handpiece is connected to the proximal end of the outer tube, and the handpiece is provided with a positioning part for locking the inner tube.
优选的,所述内管的远端为锥形。Preferably, the distal end of the inner tube is tapered.
如上所述,本发明的取栓导管以及用于取栓导管的取栓器,具有以下有益效果:通过鞘管远端的球囊充盈来阻断血流,实现将血栓围在密网状取栓件和球囊之间,易于取栓,同时密网状取栓件可使血液通过其上网孔,在进行取栓操作时可以有效避免血栓栓子在取出过程中向其他部位血管的外溢,密网状取栓件和阻断球囊取栓的同时配合负压抽吸将失血量降至最低限度;取栓器具有尖端较细的内管和管身较细的外管,可以到达血栓更深的位置;适合大中型血管的取栓,包括相对陈旧性病变,特别适合用于对肢体上的血栓进行吸取,如静脉中容量较大的血栓;本发明的取栓导管为无源取栓器械,成本低,操作简单,可大幅降低取栓手术费用。As mentioned above, the thrombus retrieval catheter and the thrombus retriever used for the thrombus retrieval catheter of the present invention have the following beneficial effects: the blood flow is blocked by filling the balloon at the distal end of the sheath tube, and the thrombus is surrounded in a dense mesh for retrieval. Between the thrombus and the balloon, it is easy to remove the thrombus. At the same time, the dense mesh thrombus removal member can allow blood to pass through the upper hole, which can effectively prevent the thrombus from overflowing to other parts of the blood vessel during the thrombus removal operation. The thrombus retrieval device with dense mesh and blocking balloon cooperates with negative pressure suction to minimize blood loss; the thrombus retriever has a thinner inner tube and a thinner outer tube, which can reach the thrombus Deeper position; suitable for thrombus removal of large and medium-sized blood vessels, including relatively old lesions, especially suitable for absorbing thrombus on limbs, such as thrombus with large capacity in veins; the thrombus removal catheter of the present invention is passive thrombus removal The device is low in cost and simple in operation, and can greatly reduce the cost of thrombectomy.
附图说明Description of drawings
图1显示为本发明的扩张器插设在阻断鞘内的示意图。Fig. 1 is a schematic view showing that the dilator of the present invention is inserted in a blocking sheath.
图2显示为沿图1中AA线的截面图。FIG. 2 shows a cross-sectional view along line AA in FIG. 1 .
图3显示为本发明的阻断鞘示意图。Fig. 3 is a schematic diagram of the blocking sheath of the present invention.
图4显示为本发明的扩张器示意图。Fig. 4 is a schematic view of the dilator of the present invention.
图5显示为本发明的取栓器示意图。Fig. 5 is a schematic diagram of the thrombus retriever of the present invention.
图6显示为沿图5中BB线的剖视图。FIG. 6 is a cross-sectional view along line BB in FIG. 5 .
图7显示为本发明的取栓器穿设在阻断鞘内且为松弛状态的示意图。Fig. 7 is a schematic diagram showing that the thrombus retriever of the present invention is worn in the blocking sheath and is in a relaxed state.
图8显示为本发明的取栓器穿设在阻断鞘内且为膨胀状态的示意图。Fig. 8 is a schematic view showing that the thrombus retriever of the present invention is inserted in the blocking sheath and is in an expanded state.
元件标号说明Component designation description
1 扩张器1 dilator
2 显影标记2 Develop mark
3 球囊3 balloons
4 鞘管4 Sheaths
5 负压抽吸装置5 Negative pressure suction device
6 手柄6 handles
7 球囊充盈接头7 Balloon inflation connector
8 手持部8 handle
9 二通9 two-way
10 连接管10 connecting pipe
11 连接卡扣11 Connection buckle
12 连接部12 Connecting part
121 凹口121 notch
13 密网状取栓件13 Dense Mesh Removal Parts
14 外管14 outer tube
15 手持件15 Handpieces
16 内管16 inner tube
17 抽拉手柄17 pull handle
具体实施方式Detailed ways
以下由特定的具体实施例说明本发明的实施方式,熟悉此技术的人士可由本说明书所揭露的内容轻易地了解本发明的其他优点及功效。The implementation of the present invention will be illustrated by specific specific examples below, and those skilled in the art can easily understand other advantages and effects of the present invention from the contents disclosed in this specification.
请参阅图1至图8。须知,本说明书所附图中所绘示的结构、比例、大小等,均仅用以配合说明书所揭示的内容,以供熟悉此技术的人士了解与阅读,并非用以限定本发明可实施的限定条件,故不具技术上的实质意义,任何结构的修饰、比例关系的改变或大小的调整,在不影响本发明所能产生的功效及所能达成的目的下,均应仍落在本发明所揭示的技术内容所能涵盖的范围内。同时,本说明书中所引用的如“上”、“下”、“左”、“右”、“中间”及“一”等的用语,亦仅为便于叙述的明了,而非用以限定本发明可实施的范围,其相对关系的改变或调整,在无实质变更技术内容下,当亦视为本发明可实施的范畴。See Figures 1 through 8. It should be noted that the structures, proportions, sizes, etc. shown in the drawings attached to this specification are only used to match the content disclosed in the specification, for those who are familiar with this technology to understand and read, and are not used to limit the implementation of the present invention. Limiting conditions, so there is no technical substantive meaning, any modification of structure, change of proportional relationship or adjustment of size, without affecting the effect and purpose of the present invention, should still fall within the scope of the present invention. within the scope covered by the disclosed technical content. At the same time, terms such as "upper", "lower", "left", "right", "middle" and "one" quoted in this specification are only for the convenience of description and are not used to limit this specification. The practicable scope of the invention and the change or adjustment of its relative relationship shall also be regarded as the practicable scope of the present invention without any substantial change in the technical content.
为便于描述,本说明书中取栓导管沿其长度方向,在使用时,远离操作者的一端定义为远端,操作者手持的一端为近端。For the convenience of description, in this manual, along the length direction of the thrombectomy catheter, when in use, the end away from the operator is defined as the distal end, and the end held by the operator is defined as the proximal end.
如图1至图8所示,本发明提供一种取栓导管,其包括:As shown in Figures 1 to 8, the present invention provides a thrombectomy catheter, which includes:
阻断鞘,见图3所示,包括鞘管4,鞘管4的远端设有球囊3,鞘管4的近端连设手柄6,且鞘管4内设有至少两个轴向延伸的腔体,第一腔体的远端与所述球囊3的内腔相通,第一腔体的近端与连设在手柄6上的球囊充盈接头7相通,在球囊3两侧的鞘管4上设有显影标记2;第二腔体的近端与连设在手柄6上的负压抽吸装置5相连通,并且所述手柄6上还设有与所述第二腔体轴向相通的开口部;The blocking sheath, as shown in Figure 3, includes a sheath tube 4, the distal end of the sheath tube 4 is provided with a balloon 3, the proximal end of the sheath tube 4 is connected with a handle 6, and the sheath tube 4 is provided with at least two axial Extended cavity, the distal end of the first cavity communicates with the inner cavity of the balloon 3, the proximal end of the first cavity communicates with the balloon filling joint 7 connected to the handle 6, and the two sides of the balloon 3 communicate with each other. The side sheath tube 4 is provided with a development mark 2; the proximal end of the second cavity communicates with the negative pressure suction device 5 connected to the handle 6, and the handle 6 is also provided with the second The opening part of the axial communication of the cavity;
扩张器1,扩张器1的外径与所述鞘管4的第二腔体内径匹配,可从所述手柄6的开口部伸入所述鞘管4的第二腔体内,扩张器1的远端从鞘管4的第二腔体内穿出并且将鞘管4的第二腔体封堵;The dilator 1, the outer diameter of the dilator 1 matches the inner diameter of the second cavity of the sheath tube 4, and can be inserted into the second cavity of the sheath tube 4 from the opening of the handle 6, the dilator 1 The distal end passes through the second cavity of the sheath tube 4 and blocks the second cavity of the sheath tube 4;
取栓器,见图5所示,包括同轴套设的外管14和内管16,以及可膨胀的密网状取栓件13,且内管16的两端均外露于外管14的两端之外,且内管16可相对外管14沿轴向移动也可相互定位不动,密网状取栓件13一端与内管16的远端相连,密网状取栓件13另一端与外管16的远端相连,抽拉内管16可使网状取栓件13膨胀或松弛;取栓器可从所述手柄6的开口部伸入所述第二腔体内,且外管14的远端从所述第二腔体内穿出,见图7及图8所示,外管14的近端外露于所述手柄6的开口部的外侧。The thrombus remover, as shown in Figure 5, includes an outer tube 14 and an inner tube 16 coaxially sleeved, and an expandable dense mesh thrombus removal member 13, and both ends of the inner tube 16 are exposed to the outer tube 14. In addition to the two ends, and the inner tube 16 can move axially relative to the outer tube 14 and can also be fixed relative to each other, one end of the dense mesh bolt removal part 13 is connected to the far end of the inner pipe 16, and the dense mesh shape bolt removal part 13 is connected to the other end. One end is connected with the distal end of the outer tube 16, and pulling the inner tube 16 can expand or relax the mesh thrombus remover 13; the thrombus remover can be inserted into the second cavity from the opening of the handle 6, and the outer The distal end of the tube 14 passes through the second cavity, as shown in FIGS. 7 and 8 , and the proximal end of the outer tube 14 is exposed outside the opening of the handle 6 .
本发明的取栓导管具有三个组件,分别为上述阻断鞘、扩张器1以及上述取栓器,通过鞘管4远端的球囊3充盈来作为血栓近端的封堵塞,以此阻断血流,实现将血栓围在密网状取栓件13和球囊3之间,易于取栓,同时密网状取栓件13可使血液通过其上网孔,且密网状取栓件13由于其致密性,在进行取栓操作时,血栓易在密网状取栓件13的表面形成止挡膜,可以有效避免血栓栓子在取出过程中越过密网状取栓件向其他部位血管的外溢,密网状取栓件和阻断球囊取栓的同时配合负压抽吸,将失血量降至最低限度,特别适合用于吸取静脉中大容量的血栓。The thrombus retrieval catheter of the present invention has three components, which are the above-mentioned blocking sheath, the dilator 1 and the above-mentioned thrombus retriever, and the balloon 3 at the distal end of the sheath tube 4 is filled to serve as a blockage at the proximal end of the thrombus, so as to block the thrombus. The blood flow is cut off, and the thrombus can be surrounded between the dense mesh thrombus removal part 13 and the balloon 3, which is easy to remove the thrombus. 13 Due to its compactness, during the thrombus removal operation, the thrombus is easy to form a stopper film on the surface of the dense mesh thrombus removal member 13, which can effectively prevent the thrombus from crossing the dense mesh thrombus removal member 13 to other parts during the removal process. The extravasation of blood vessels, the dense mesh thrombus removal device and blocking balloon thrombus removal combined with negative pressure suction can reduce blood loss to a minimum, and are especially suitable for absorbing large-capacity thrombus in veins.
本实施例上述手柄6的开口部处设有连接卡扣11,所述扩张器1上设有与所述连接卡扣11配合固定的连接部12,通过连接部12和连接卡扣11的固定使扩张器1与阻断鞘固定,便于穿入血管内。本实施例中连接卡扣11上设有凸起部,连接部12上具有凹口121,扩张器1从手柄6的开口部穿入上述鞘管4的第二腔体内时,通过凸起部卡合在凹口121内,实现扩张器1与阻断鞘的定位相连,凸起部和凹口121的配合也便于两者的分离,易将扩张器1从阻断鞘内抽出。In this embodiment, the opening of the above-mentioned handle 6 is provided with a connecting buckle 11, and the dilator 1 is provided with a connecting portion 12 that is fixed with the connecting buckle 11, and is fixed by the connecting portion 12 and the connecting buckle 11. The dilator 1 and the blocking sheath are fixed to facilitate penetration into blood vessels. In this embodiment, a raised portion is provided on the connecting buckle 11, and a notch 121 is provided on the connecting portion 12. Engaging in the notch 121 realizes the positioning and connection of the dilator 1 and the blocking sheath. The cooperation between the protrusion and the notch 121 also facilitates the separation of the two, and the dilator 1 is easily pulled out from the blocking sheath.
上述手柄6与扩张器1的定位相连不限于上述连接卡扣12和连接部11的配合,其也可以通过设置可旋转的定位部来实现,定位部旋紧后可锁定扩张器。上述手柄6同样可以通过旋转的定位部来锁定取栓器。The connection between the above-mentioned handle 6 and the dilator 1 is not limited to the cooperation between the above-mentioned connecting buckle 12 and the connecting part 11, it can also be realized by setting a rotatable positioning part, and the dilator can be locked after the positioning part is tightened. The above-mentioned handle 6 can also lock the thrombus retriever through the rotating positioning part.
为便于穿插上述扩张器1,扩张器1的近端连设一手持部8,操作者可手握手持部8将扩张器1从上述手柄6的开口部插入鞘管4内。为便于医学影像,本实施例中扩张器1采用聚乙烯或聚氨酯等热塑性弹性体制成,且热塑性弹性体内填充有含显影剂材质硫酸钡、氧化铋或氯氧化铋。In order to facilitate insertion of the dilator 1 , a handle 8 is provided at the proximal end of the dilator 1 . The operator can hold the handle 8 and insert the dilator 1 into the sheath 4 through the opening of the handle 6 . In order to facilitate medical imaging, the dilator 1 in this embodiment is made of thermoplastic elastomer such as polyethylene or polyurethane, and the thermoplastic elastomer is filled with barium sulfate, bismuth oxide or bismuth oxychloride containing developer materials.
本实施例中阻断鞘中的鞘管4为双腔结构或多腔结构,其中一个腔体即上述第一腔体用作充盈球囊3的通道,另一个腔体即上述第二腔体作为工作腔,用于穿设上述扩张器1或上述取栓器或其他医疗器械进出血管,鞘管4的材质为聚氨酯或聚酰胺类热塑性弹性体。本实施例中球囊3的材质为天然乳胶、合成橡胶、硅胶或聚氨酯等热塑性弹性体,通过手柄6上的球囊充盈腔接头7注入造影剂,使顺应性球囊充盈扩张,以形成阻断血液流通作用。为便于抽取血栓,本实施例中上述负压抽吸装置5通过连接管10与手柄6相连,且负压抽吸装置5还连设有二通9,便于与电动负压吸引器相连,形成抽吸负压,使血栓更高效地从阻断鞘内流入负压抽吸装置5的收集装置中。In this embodiment, the sheath tube 4 in the blocking sheath is a double-lumen structure or a multi-lumen structure, one of which is the first cavity used as a passage for filling the balloon 3, and the other cavity is the second cavity As a working chamber, it is used to pass the above-mentioned dilator 1 or the above-mentioned thrombus retriever or other medical devices into and out of blood vessels, and the material of the sheath tube 4 is polyurethane or polyamide thermoplastic elastomer. In this embodiment, the material of the balloon 3 is a thermoplastic elastomer such as natural latex, synthetic rubber, silica gel or polyurethane, and a contrast agent is injected through the balloon filling cavity joint 7 on the handle 6 to fill and expand the compliant balloon to form a barrier. Cut off blood circulation. In order to facilitate the extraction of thrombus, the above-mentioned negative pressure suction device 5 is connected to the handle 6 through the connecting pipe 10 in this embodiment, and the negative pressure suction device 5 is also provided with a two-way 9, which is convenient to be connected with the electric negative pressure suction device, forming Suction the negative pressure so that the thrombus can flow from the blocking sheath into the collection device of the negative pressure suction device 5 more efficiently.
本实施例中上述取栓器中,密网状取栓件13由超弹记忆镍钛合金丝编织而成,并混编入一定数量的铂铱合金丝、黄金丝或不锈钢丝用于X光机下显影,其可允许取栓时血液流过密网状取栓件,在进行取栓操作时可以有效避免血栓栓子在取出过程中向其他部位血管的外溢;密网状取栓件取栓的同时配合负压抽吸,可有效减少失血量,可有效提升血栓抽吸效果。本实施例中的密网状取取栓件其所用的超弹记忆镍钛合金丝非常细,且编织成的网孔其孔径大约在0.3-1.0mm间,也就是说本实施例的密网状取栓件其为致密性的网状件,既能使血液通过,又能防止血栓块通过。外管14和内管16均采用聚酰胺类热塑性弹性体制成。整个取栓器材质柔软,在取栓过程中,降低血管内膜的损伤。In the above-mentioned thrombus remover in this embodiment, the dense mesh-shaped thrombus remover 13 is woven by superelastic memory nickel-titanium alloy wire, and mixed with a certain amount of platinum-iridium alloy wire, gold wire or stainless steel wire for X-ray Under-machine imaging, which allows blood to flow through the dense mesh thrombus removal device during thrombectomy, can effectively prevent thrombus and embolus from overflowing to other parts of the blood vessel during the removal process; the dense mesh thrombus removal device At the same time as the thrombus is combined with negative pressure suction, it can effectively reduce blood loss and improve the effect of thrombus suction. The superelastic memory nickel-titanium alloy wire used in the dense mesh-like bolt-taking part in this embodiment is very thin, and the aperture of the woven mesh is about 0.3-1.0mm, that is to say, the dense mesh of the present embodiment The thrombus-removing part is a dense mesh part, which can not only allow blood to pass through, but also prevent thrombus from passing through. Both the outer tube 14 and the inner tube 16 are made of polyamide thermoplastic elastomer. The material of the entire thrombus retriever is soft, which reduces the damage to the vascular intima during the thrombectomy process.
为便于密网状取栓件的膨胀和松弛,本实施例中上述外管14的近端连设一个手持件15,见图5所示,手持件15的近端设有将内管16锁定的定位部。本实施例中手持件15可作手柄使用,便于操作者拿取取栓器。手持件15内的定位部可将内管16和外管14相定位,可使网状取栓件13保持呈膨胀状态,便于将血栓拉入阻断鞘内。该定位部可为旋转式或开关式的锁定件,通过旋转或开关实现内管和外管的锁定。In order to facilitate the expansion and relaxation of the dense mesh bolt removing part, a handpiece 15 is connected to the proximal end of the above-mentioned outer tube 14 in this embodiment. As shown in FIG. positioning department. In this embodiment, the handpiece 15 can be used as a handle, which is convenient for the operator to take the thrombus remover. The positioning part in the hand piece 15 can position the inner tube 16 and the outer tube 14, and keep the mesh thrombus removing part 13 in an expanded state, so as to facilitate pulling the thrombus into the blocking sheath. The positioning part can be a rotary or switch-type locking piece, and the inner tube and the outer tube can be locked by rotating or switching.
见图5及图6所示,本实施例中内管16穿设在外管14内,且内管16的长度长于外管14的长度,内管16的两端均位于外管14的外面,密网状取栓件13的一端与内管16的远端相连,密网状取栓件13的另一端与外管14的远端相连,通过抽拉内管16改变内管16的远端和外管远端的相对距离,以此使密网状取栓件13膨胀和松弛,沿图5中的箭头方向抽拉内管,则密网状取栓件膨胀,反之则松弛。As shown in Figures 5 and 6, in this embodiment, the inner tube 16 is installed in the outer tube 14, and the length of the inner tube 16 is longer than the length of the outer tube 14, and both ends of the inner tube 16 are located outside the outer tube 14. One end of the dense mesh thrombus removing part 13 is connected to the distal end of the inner tube 16, the other end of the dense mesh thrombus removing part 13 is connected to the distal end of the outer tube 14, and the distal end of the inner tube 16 is changed by pulling the inner tube 16 The relative distance from the distal end of the outer tube is used to expand and relax the dense mesh thrombus removing part 13. If the inner tube is pulled in the direction of the arrow in Fig. 5, the dense mesh thrombus removing part expands, otherwise it relaxes.
为便于抽拉内管,见图5所示,本实施例中内管16的近端连设有抽拉手柄17。为便于取栓器穿过血栓,运行至血栓的远端,本实施例中内管16的远端圆润且有一定锥度,即其端部为锥形。In order to facilitate the drawing of the inner tube, as shown in FIG. 5 , the proximal end of the inner tube 16 in this embodiment is connected with a drawing handle 17 . In order to facilitate the thrombus retriever to pass through the thrombus and run to the distal end of the thrombus, the distal end of the inner tube 16 in this embodiment is rounded and has a certain taper, that is, its end is tapered.
采用上述取栓导管对血管中血栓进行抽取的具体过程如下:The specific process of using the above-mentioned thrombus removal catheter to extract thrombus in the blood vessel is as follows:
对血管进行穿刺插管,通过动脉或静脉造影,了解血栓位置及周围血管情况后,首先将上述扩张器1穿设在鞘管4的第二腔体内,见图1及图2所示为扩张器1穿设在阻断鞘内的状态,然后在导丝引导下,将上述鞘管4引导至血栓近端;用生理盐水或其他合适药液,连接球囊腔接头7充盈球囊3至血管内径大小,使球囊将血栓近端的血管堵塞,阻断血流;从阻断鞘中撤出扩张器1,沿着导丝放入取栓器,见图7所示,取栓器中的密网状取栓件13穿过血栓,放置到血栓的远端;向外拉动取栓器的内管16,见图8所示,密网状取栓件13膨胀,将内管16与外管14锁定,保持密网状取栓件13为膨胀状态;向外拉动外管14,将血栓收入阻断鞘的鞘管4内,同步的,通过负压抽吸将血栓排入负压抽吸装置5中,且在拉血栓时,血液可通过密网状取栓件13,降低失血量,但是块状血栓会随吸力被吸出;某段血管取栓完毕后,通过充、放阻断鞘上的球囊,移动到下一段血栓处进行取栓操作。本实施例取栓器较细的尖端和管身,可以到达血栓更深的位置。Puncture and intubate the blood vessel, and after knowing the position of the thrombus and the surrounding blood vessels through arterial or venography, firstly, the above-mentioned dilator 1 is inserted in the second cavity of the sheath tube 4, as shown in Figure 1 and Figure 2. The device 1 is placed in the blocking sheath, and then under the guidance of the guide wire, guide the above-mentioned sheath tube 4 to the proximal end of the thrombus; use physiological saline or other suitable medicinal liquid to connect the balloon lumen joint 7 to fill the balloon 3 to the The inner diameter of the blood vessel is such that the balloon blocks the blood vessel proximal to the thrombus and blocks the blood flow; withdraw the dilator 1 from the blocking sheath, and place the thrombus retriever along the guide wire, as shown in Figure 7, the thrombus retriever The dense mesh thrombus removal part 13 passes through the thrombus and is placed on the distal end of the thrombus; the inner tube 16 of the thrombus remover is pulled outward, as shown in Figure 8, the dense mesh thrombus removal part 13 expands, and the inner tube 16 Locking with the outer tube 14, keeping the dense mesh thrombus removing part 13 in an expanded state; pulling the outer tube 14 outward to draw the thrombus into the sheath tube 4 of the blocking sheath, and simultaneously, the thrombus is discharged into the negative through negative pressure suction. In the suction device 5, and when the thrombus is pulled, the blood can pass through the dense mesh thrombus removal part 13 to reduce the blood loss, but the massive thrombus will be sucked out with the suction; The balloon on the blocking sheath is moved to the next thrombus for thrombus removal. The thinner tip and tube body of the thrombus retriever in this embodiment can reach the deeper position of the thrombus.
综上所述,本发明的取栓导管以及用于取栓导管的取栓器,其通过阻断鞘远端的球囊充盈阻断血流,在取栓过程中,柔软的取栓器,降低血管内膜的损伤;密网状取栓件可以使血液通过其上网孔,在进行取栓操作时可以有效避免血栓栓子在取出过程中向其他部位血管的外溢,密网状取栓件取栓的同时配合负压抽吸,利于血栓去除,将失血量降至最低限度;取栓器的内管具有较细的尖端和管身,可以到达血栓更深的位置;适合大中型血管的取栓,包括相对陈旧性病变;本发明为无源取栓器械,成本低,操作简单,可大幅降低取栓手术费用;可高效率取出大容量血栓,减少瓣膜损伤,更少量溶栓药物应用,更少量失血,更小创伤,更快恢复期。所以,本发明有效克服了现有技术中的种种缺点而具高度产业利用价值。In summary, the thrombus retrieval catheter and the thrombus retriever used for the thrombus retrieval catheter of the present invention block the blood flow by filling the balloon at the distal end of the blocking sheath. During the thrombectomy process, the soft thrombus retriever, Reduce the damage of the intima of the blood vessel; the dense mesh thrombus removal piece can allow blood to pass through the holes on it, and can effectively prevent the thrombus from overflowing to other parts of the blood vessel during the thrombus removal operation. The dense mesh thrombus removal piece Thrombectomy is combined with negative pressure suction, which facilitates thrombus removal and minimizes blood loss; the inner tube of the thrombus retriever has a thinner tip and tube body, which can reach a deeper position in the thrombus; it is suitable for the removal of large and medium-sized blood vessels Thrombus, including relatively old lesions; the present invention is a passive thrombus removal device with low cost and simple operation, which can greatly reduce the cost of thrombus removal surgery; it can remove large-capacity thrombus with high efficiency, reduce valve damage, and use less thrombolytic drugs. Less blood loss, less trauma, faster recovery period. Therefore, the present invention effectively overcomes various shortcomings in the prior art and has high industrial application value.
上述实施例仅例示性说明本发明的原理及其功效,而非用于限制本发明。任何熟悉此技术的人士皆可在不违背本发明的精神及范畴下,对上述实施例进行修饰或改变。因此,举凡所属技术领域中具有通常知识者在未脱离本发明所揭示的精神与技术思想下所完成的一切等效修饰或改变,仍应由本发明的权利要求所涵盖。The above-mentioned embodiments only illustrate the principles and effects of the present invention, but are not intended to limit the present invention. Anyone skilled in the art can modify or change the above-mentioned embodiments without departing from the spirit and scope of the present invention. Therefore, all equivalent modifications or changes made by those skilled in the art without departing from the spirit and technical ideas disclosed in the present invention shall still be covered by the claims of the present invention.
Claims (13)
Priority Applications (2)
| Application Number | Priority Date | Filing Date | Title |
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| CN201810052511.6A CN108143464A (en) | 2018-01-19 | 2018-01-19 | Thrombectomy Catheter and Thrombectomy for Thrombectomy Catheter |
| CN202111270425.0A CN113974766B (en) | 2018-01-19 | 2018-01-19 | Thrombolysis catheter |
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| CN113974766A (en) * | 2018-01-19 | 2022-01-28 | 上海唯域医疗科技有限公司 | thrombectomy catheter |
| CN109044484A (en) * | 2018-07-26 | 2018-12-21 | 河南亚都实业有限公司 | A kind of conduit of manual aspirate thrombi |
| CN109044483A (en) * | 2018-07-26 | 2018-12-21 | 河南亚都实业有限公司 | A kind of conduit for removal of thromboses |
| CN109350178A (en) * | 2018-12-05 | 2019-02-19 | 上海微创心脉医疗科技股份有限公司 | thrombectomy device |
| CN109350178B (en) * | 2018-12-05 | 2024-10-01 | 上海蓝脉医疗科技有限公司 | Thrombectomy Device |
| CN111759399A (en) * | 2018-12-05 | 2020-10-13 | 上海蓝脉医疗科技有限公司 | Thrombus taking device |
| WO2021035961A1 (en) * | 2019-08-28 | 2021-03-04 | 香港大学深圳医院 | Balloon catheter sheath |
| CN110464422A (en) * | 2019-08-28 | 2019-11-19 | 香港大学深圳医院 | Foley's tube sheath |
| CN112438777A (en) * | 2019-08-28 | 2021-03-05 | 尤东侠 | Minimally invasive thrombus extraction device for treating vascular embolism |
| CN110680462A (en) * | 2019-11-06 | 2020-01-14 | 上海慧达医疗器械有限公司 | Thrombus stripping instrument |
| WO2021097742A1 (en) * | 2019-11-21 | 2021-05-27 | 香港大学深圳医院 | Single-balloon internal drainage catheter sheath |
| CN111419338A (en) * | 2020-04-14 | 2020-07-17 | 玮铭医疗器械(上海)有限公司 | Balloon suction catheter device for intracranial thrombus removal |
| CN111419339A (en) * | 2020-04-20 | 2020-07-17 | 上海心玮医疗科技有限公司 | A double-umbrella type adjustable bolt removal device |
| CN111870795A (en) * | 2020-04-27 | 2020-11-03 | 浙江归创医疗器械有限公司 | Aorta diversion catheter |
| CN111938748A (en) * | 2020-07-24 | 2020-11-17 | 上海璞慧医疗器械有限公司 | Thrombus taking device |
| CN113440718A (en) * | 2021-06-23 | 2021-09-28 | 上海翰凌医疗器械有限公司 | Cerebral embolism prevention type balloon dilatation catheter |
| CN113456172A (en) * | 2021-07-14 | 2021-10-01 | 福建医科大学附属第一医院 | Inflatable near-end embolectomy catheter |
| CN113456171A (en) * | 2021-07-14 | 2021-10-01 | 福建医科大学附属第一医院 | Near-end embolectomy catheter |
| CN113729860A (en) * | 2021-08-16 | 2021-12-03 | 万漉医疗科技(江苏)有限公司 | Thrombus removal device and method |
| CN113907836A (en) * | 2021-11-17 | 2022-01-11 | 上海腾复医疗科技有限公司 | Hemodialysis access thrombectomy device |
| CN114145810A (en) * | 2021-12-24 | 2022-03-08 | 赛诺神畅医疗科技有限公司 | Thrombus extraction device and use method thereof |
| CN114145810B (en) * | 2021-12-24 | 2024-01-30 | 赛诺神畅医疗科技有限公司 | Thrombectomy device and method of using the same |
| CN114305584B (en) * | 2021-12-29 | 2023-12-22 | 北京泰杰伟业科技股份有限公司 | Catheter system for cerebral venous sinus thrombus removal |
| CN114305584A (en) * | 2021-12-29 | 2022-04-12 | 北京泰杰伟业科技有限公司 | Catheter system for taking thrombus from cerebral venous sinus |
| CN115429381A (en) * | 2022-08-24 | 2022-12-06 | 玮铭医疗器械(上海)有限公司 | Thrombus aspiration catheter device |
| CN115624369A (en) * | 2022-10-31 | 2023-01-20 | 江苏省中医院 | A hemodialysis semi-permanent venous catheter thrombus removal device |
| CN116602738A (en) * | 2023-02-01 | 2023-08-18 | 上海腾复医疗科技有限公司 | Adjustable thrombectomy device |
| CN116158806A (en) * | 2023-04-26 | 2023-05-26 | 北京心祐医疗科技有限公司 | Thrombus aspiration component and thrombus taking expansion device |
| CN116999120A (en) * | 2023-09-27 | 2023-11-07 | 苏州大学附属第二医院 | A thrombectomy device |
| CN116999120B (en) * | 2023-09-27 | 2024-04-19 | 苏州大学附属第二医院 | Thrombectomy device |
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