CN114903557A - A suction device and method for making and using the same - Google Patents
A suction device and method for making and using the same Download PDFInfo
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- CN114903557A CN114903557A CN202210514303.XA CN202210514303A CN114903557A CN 114903557 A CN114903557 A CN 114903557A CN 202210514303 A CN202210514303 A CN 202210514303A CN 114903557 A CN114903557 A CN 114903557A
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- 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
- A61B2017/22079—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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Abstract
Description
技术领域technical field
本发明涉及医疗器械技术领域,尤其涉及一种吸取器械以及吸取器械的制作方法和使用方法。The invention relates to the technical field of medical devices, in particular to a suction device and a method for making and using the suction device.
背景技术Background technique
脑卒中是一种急性脑血管疾病,是由于脑部血管突然破裂或因血管阻塞导致血液不能流入大脑而引起脑组织损伤的一种疾病,包括缺血性和出血性卒中。其中缺血性卒中,其发病率高于出血性卒中,占脑卒中总数的60%~70%。严重脑卒中可造成永久性神经损伤,急性期如果不及时诊断和治疗可造成严重的并发症,甚至死亡。同时,脑卒中还具有发病率高、死亡率高和致残率高的特点。Stroke is an acute cerebrovascular disease, a disease that damages brain tissue due to sudden rupture of blood vessels in the brain or blockage of blood vessels that prevents blood from flowing into the brain, including ischemic and hemorrhagic strokes. Among them, the incidence of ischemic stroke is higher than that of hemorrhagic stroke, accounting for 60% to 70% of the total number of strokes. Severe stroke can cause permanent neurological damage, and if not diagnosed and treated in time in the acute phase, serious complications and even death can result. At the same time, stroke also has the characteristics of high morbidity, high mortality and high disability rate.
现代医疗根据脑卒中不同部位和不同类型,其治疗方式也有所不同。主要分为药物溶栓治疗和外科手术治疗。其中药物溶栓治疗是一种有效的救治方法,但有严格的时间窗要求,溶栓治疗的最佳时间是6个小时之内。介入治疗是外科手术的一种,随着技术的进步,以及介入治疗创伤小恢复快的特点,介入治疗成为快速发展的方向。对于缺血性脑卒中,常常采用血管内机械取栓方式,将取栓器械输送到病灶部位,并采用包括血栓切除术、激光取栓、捕栓网取栓和抽吸取栓等方式。但是抽吸取栓在操作过程中,仍存在较小碎栓随血流逃逸的可能。而且长时间的抽吸,会导致失血过多,引起生命危险。Modern medicine has different treatment methods according to different parts and types of stroke. Mainly divided into drug thrombolysis and surgical treatment. Among them, drug thrombolytic therapy is an effective treatment method, but there are strict time window requirements, and the best time for thrombolytic therapy is within 6 hours. Interventional therapy is a kind of surgical operation. With the advancement of technology and the characteristics of small trauma and quick recovery, interventional therapy has become a direction of rapid development. For ischemic stroke, intravascular mechanical thrombectomy is often used to deliver the thrombectomy device to the lesion site, and methods including thrombectomy, laser thrombectomy, thrombectomy net, and thrombectomy are used. However, during the operation of the suction thrombus, there is still the possibility of small fragments of thrombus escaping with the blood flow. And prolonged suction, will lead to excessive blood loss, causing life-threatening.
因此,如何提供一种吸取器械,以克服现有技术中存在的上述缺陷,日益成为本领域技术人员亟待解决的技术问题之一。Therefore, how to provide a suction device to overcome the above-mentioned defects in the prior art has increasingly become one of the technical problems to be solved urgently by those skilled in the art.
发明内容SUMMARY OF THE INVENTION
本发明的目的在于提供一种吸取器械以及吸取器械的制作方法和使用方法,以解决现有技术存在的抽吸取栓方式在操作过程中,仍存在较小碎栓随血流逃逸的可能,以及长时间的抽吸导致失血过多的问题。The object of the present invention is to provide a suction device and a method for making and using the suction device, so as to solve the problem of the possibility of small thrombus escaping with the blood flow during the operation of the suction and suction thrombus method existing in the prior art, and Prolonged suction leads to problems with excessive blood loss.
为了达到上述目的,本发明提供了一种吸取器械,包括输送管路、推送装置和沿径向方向可自适应调节尺寸的喇叭口;In order to achieve the above object, the present invention provides a suction device, comprising a conveying pipeline, a pushing device and a bell mouth whose size can be adjusted adaptively along the radial direction;
其中,所述喇叭口的小口端连接所述输送管路的远端;Wherein, the small mouth end of the bell mouth is connected to the distal end of the conveying pipeline;
所述推送装置通过所述输送管路的近端伸入所述输送管路和所述喇叭口内部,且所述推送装置的远端可拆卸的与所述喇叭口的大口端连接,所述推送装置被配置为带动所述喇叭口沿所述输送管路的轴向移动。The pushing device extends into the conveying line and the inside of the bell mouth through the proximal end of the conveying line, and the distal end of the pushing device is detachably connected to the large end of the bell mouth, and the The pushing device is configured to drive the bell mouth to move in the axial direction of the conveying pipeline.
可选的,所述喇叭口包括弹性本体和设置在所述弹性本体内的支撑结构;Optionally, the bell mouth includes an elastic body and a support structure disposed in the elastic body;
其中,所述支撑结构被配置为,在无外力作用时能够使得所述弹性本体呈喇叭状。Wherein, the support structure is configured so that the elastic body can be trumpet-shaped when no external force acts.
可选的,所述支撑结构包括一组远端支撑段、一组近端支撑段以及设置在所述远端支撑段和所述近端支撑段之间的至少一组中间支撑段,每组支撑段包括至少两根半径和弧长相等的圆弧段;Optionally, the support structure includes a set of distal support segments, a set of proximal support segments, and at least one set of intermediate support segments disposed between the distal support segments and the proximal support segments, each set of The support segment includes at least two circular arc segments with equal radius and arc length;
其中,所述远端支撑段位于所述喇叭口的大口端,所述近端支撑段位于所述喇叭口的小口端;Wherein, the distal support section is located at the large mouth end of the bell mouth, and the proximal support section is located at the small mouth end of the bell mouth;
所述远端支撑段的圆弧段的半径和弧长大于所述中间支撑段的圆弧段的半径和弧长,所述中间支撑段的圆弧段的半径和弧长大于所述近端支撑段的圆弧段的半径和弧长,从所述喇叭口的大口端至小口端,所述中间支撑段的圆弧段的半径和弧长依次减小;The radius and arc length of the circular arc segment of the distal support segment are greater than the radius and arc length of the circular arc segment of the intermediate support segment, and the radius and arc length of the circular arc segment of the intermediate support segment are greater than those of the proximal end The radius and arc length of the circular arc segment of the support segment decrease sequentially from the large mouth end to the small mouth end of the bell mouth;
任意一组所述支撑段的圆弧段沿所述喇叭口的轴向方向错位对称排布,且在无沿径向向内的作用力时形成一不闭合圆环。The arc segments of any group of the support segments are dislocated and symmetrically arranged along the axial direction of the bell mouth, and form an open ring when there is no radially inward acting force.
可选的,所述远端支撑段包括的圆弧段的半径>血管内壁半径。Optionally, the radius of the arc segment included in the distal support segment is greater than the radius of the inner wall of the blood vessel.
可选的,所述弹性本体的材质包括:聚四氟乙烯、聚酰胺、聚氨酯、聚醚嵌段酰胺和/或硅橡胶;所述支撑结构的材质包括:镍钛合金和/或不锈钢。Optionally, the material of the elastic body includes: polytetrafluoroethylene, polyamide, polyurethane, polyether block amide and/or silicone rubber; the material of the support structure includes: nickel-titanium alloy and/or stainless steel.
可选的,所述推送装置包括至少两根推送杆,所述两根推送杆的远端和所述喇叭口的大口端可分离连接,且所述推送杆关于所述喇叭口的中轴线对称。Optionally, the push device includes at least two push rods, the distal ends of the two push rods and the large mouth end of the bell mouth can be detachably connected, and the push rod is symmetrical about the central axis of the bell mouth. .
可选的,还包括电解脱分离装置,所述两根推送杆的远端与所述喇叭口相连处设有电解脱点,所述电解脱分离装置用于将所述两根推送杆从所述电解脱点处脱离。Optionally, it also includes an electrolytic decoupling device, where the distal ends of the two push rods are connected to the bell mouth with an electrolytic decoupling point, and the electrolytic decoupling device is used to remove the two push rods from the Detached at the point of electrolysis.
可选的,所述输送管路和/或所述喇叭口的的外壁还设置有润滑层。Optionally, a lubricating layer is further provided on the outer wall of the conveying pipeline and/or the bell mouth.
本发明还提供一种吸取器械的制作方法,包括制作上述的吸取器械,具体制作步骤如下:The present invention also provides a method for making a suction device, including making the above-mentioned suction device, and the specific fabrication steps are as follows:
利用锥型模具加工一层PTFE材料作为所述喇叭口的内层;Utilize a conical mold to process a layer of PTFE material as the inner layer of the bell mouth;
沿着所述锥形模具由小至大的方向,依次间隔固定距离,在所述锥形模具的小端固定所述近端支撑段,在所述锥形模具的大端固定远端支撑段,在所述锥形模具的小端与大端之间固定至少一种中间支撑段,每组支撑段包括的圆弧段错位对称排布;Along the direction of the tapered mold from small to large, at fixed distances in turn, fix the proximal support section at the small end of the tapered mold, and fix the distal support section at the large end of the tapered mold , at least one intermediate support segment is fixed between the small end and the large end of the conical die, and the arc segments included in each group of support segments are dislocated and symmetrically arranged;
加工Pebax材料作为所述喇叭口的外层;Processing Pebax material as the outer layer of the flare;
固定所述喇叭口的内层、所述每组支撑段和所述喇叭口的外层;Fixing the inner layer of the bell mouth, each group of support sections and the outer layer of the bell mouth;
将所述推送装置的远端伸入所述输送管路和所述喇叭口内并与所述喇叭口的大口端连接。The distal end of the pushing device is inserted into the conveying pipeline and the bell mouth and connected with the large mouth end of the bell mouth.
本发明又提供一种吸取器械的使用方法,包括使用上述任一项所述的吸取器械,具体使用步骤如下:The present invention further provides a method for using a suction device, including using any of the suction devices described above, and the specific use steps are as follows:
利用指引导管将所述吸取器械运送至血管内病灶处;using the guiding catheter to transport the suction device to the intravascular lesion;
向所述推送装置的远端方向推动所述喇叭口,直至所述推送装置将所述喇叭口推出所述输送管路并与所述血管内壁贴合;Pushing the bell mouth toward the distal end of the pushing device, until the pushing device pushes the bell mouth out of the delivery pipeline and fits with the inner wall of the blood vessel;
将所述推送装置和所述喇叭口的大口端分离,并移除所述推送装置;separating the pushing device from the large mouth end of the bell mouth, and removing the pushing device;
通过所述输送管路的近端向所述吸取器械施加抽吸力进行抽吸。Suction is performed by applying a suction force to the suction instrument through the proximal end of the delivery line.
与现有技术相比,本发明提供的一种吸取器械以及吸取器械的制作方法和使用方法具有以下有益效果:Compared with the prior art, the invention provides a suction device and a method for making and using the suction device with the following beneficial effects:
本发明提供的一种吸取器械,包括输送管路、推送装置和沿径向方向可自适应调节尺寸的喇叭口;其中,所述喇叭口的小口端连接所述输送管路的远端;所述推送装置通过所述输送管路的近端伸入所述输送管路和所述喇叭口内部,且所述推送装置的远端可拆卸的与所述喇叭口的大口端连接,所述推送装置被配置为带动所述喇叭口沿所述输送管路的轴向移动。本发明通过将所述吸取器械在输送过程中保持受力收缩状态,使得所述吸取器械在输送过程中的整体尺寸以及输送阻力减小,便于将所述吸取器械运送至病灶处。当所述吸取器械到达病灶后,通过推动所述推送装置将所述喇叭口推出受力范围,使得所述喇叭口在无径向作用力的情况下逐渐扩张呈喇叭型,所述喇叭口在扩张过程中能够顺应血管内壁尺寸自动调节大小并最终达到紧贴血管内壁的效果,由此保障了在后续抽吸过程中血管内血液和血栓无其他通道可走,只能通过所述输送管路流出,从而减少病灶处血栓逃逸的可能。同时在利用所述吸取器械进行血栓抽吸时,由于所述喇叭口紧贴所述血管内壁,所述喇叭口与所述血管内壁之间无空隙,因此所述吸取器械在同等抽吸压力下无压力损失,从而增大了吸取器械的抽吸压差,使得所述吸取器械在抽吸过程中能够所以将大小血栓全部抽吸完全,进一步减少血栓逃逸后造成其他血管栓塞的可能。The invention provides a suction device, comprising a conveying pipeline, a pushing device and a bell mouth whose size can be adaptively adjusted in a radial direction; wherein, the small mouth end of the bell mouth is connected to the distal end of the conveying pipeline; The pushing device extends into the conveying line and the inside of the bell mouth through the proximal end of the conveying line, and the distal end of the pushing device is detachably connected to the large mouth end of the bell mouth, and the pushing device The device is configured to drive the bell mouth to move in the axial direction of the conveying pipeline. In the present invention, by keeping the suction device in a force-contracted state during the delivery process, the overall size and delivery resistance of the suction device during the delivery process are reduced, so that the suction device can be easily transported to the lesion. When the suction device reaches the lesion, the bell mouth is pushed out of the force range by pushing the pushing device, so that the bell mouth gradually expands into a horn shape without radial force. During the expansion process, it can automatically adjust the size according to the size of the inner wall of the blood vessel, and finally achieve the effect of sticking to the inner wall of the blood vessel, thus ensuring that there is no other channel for blood and thrombus in the blood vessel during the subsequent suction process, and only through the delivery pipeline. outflow, thereby reducing the possibility of thrombus escaping from the lesion. At the same time, when the suction device is used for thrombus suction, since the bell mouth is close to the inner wall of the blood vessel, there is no gap between the bell mouth and the inner wall of the blood vessel, so the suction device is under the same suction pressure. There is no pressure loss, thereby increasing the suction pressure difference of the suction device, so that the suction device can completely suck all the large and small thrombi during the suction process, further reducing the possibility of other blood vessel embolism caused by the escape of the thrombus.
本发明提供的吸取器械的使用方法为使用上述的吸取器械,以及利用本发明提供的吸取器械的制作方法制作的上述吸取器械,都是通过所述吸取器械进行抽吸工作,因此至少具有相同的技术效果,在此就不一一赘述。The use method of the suction device provided by the present invention is to use the above-mentioned suction device, and the above-mentioned suction device manufactured by using the method for manufacturing the suction device provided by the present invention all perform suction work through the suction device, so at least the same The technical effects will not be repeated here.
附图说明Description of drawings
图1为本发明一实施例提供的吸取器械的喇叭口处于收缩状态时结构示意图;1 is a schematic structural diagram of a suction device provided by an embodiment of the present invention when the bell mouth is in a contracted state;
图2为本发明一实施例提供的吸取器械的喇叭口处于半扩张状态时结构示意图;2 is a schematic structural diagram of the bell mouth of the suction device provided in an embodiment of the present invention when it is in a semi-expanded state;
图3为本发明一实施例提供的吸取器械的喇叭口处于扩张状态时的结构示意图;3 is a schematic structural diagram of the bell mouth of the suction device provided in an embodiment of the present invention when the bell mouth is in an expanded state;
图4为本发明一实施例提供的吸取器械吸取血栓的过程示意图;4 is a schematic diagram of a process of sucking a thrombus with a suction device according to an embodiment of the present invention;
其中,附图标记如下:Among them, the reference numerals are as follows:
100-输送管路,200-喇叭口,201-支撑结构,400-推送装置,401-电解脱点,500-血管,600-血栓。100-delivery pipeline, 200-flare mouth, 201-support structure, 400-pushing device, 401-electrolysis point, 500-vascular, 600-thrombus.
具体实施方式Detailed ways
下面将结合示意图对本发明的具体实施方式进行更详细的描述。根据下列描述,本发明的优点和特征将更清楚。需说明的是,附图均采用非常简化的形式且均使用非精准的比例,仅用以方便、明晰地辅助说明本发明实施例的目的。应当了解,说明书附图并不一定按比例的显示本发明的具体结构,并且在说明书附图中用于说明本发明某些原理的图示性特征也会采取略微简化的画法。本文所公开的本发明的具体设计特征包括例如具体尺寸、方向、位置和外形将部分地由具体所要应用和使用的环境来确定。以及,在以下说明的实施方式中,有时在不同的附图之间共同使用同一附图标记来表示相同部分或具有相同功能的部分,而省略其重复说明。在本说明书中,使用相似的标号和字母表示类似项,因此,一旦某一项在一个附图中被定义,则在随后的附图中不需要对其进行进一步讨论。The specific embodiments of the present invention will be described in more detail below with reference to the schematic diagrams. The advantages and features of the present invention will become more apparent from the following description. It should be noted that, the accompanying drawings are all in a very simplified form and in inaccurate scales, and are only used to facilitate and clearly assist the purpose of explaining the embodiments of the present invention. It should be understood that the drawings in the specification do not necessarily show specific structures of the invention to scale and that the illustrative features in the drawings for illustrating certain principles of the invention may also be shown in somewhat simplified representation. The specific design features of the invention disclosed herein, including, for example, the specific dimensions, orientations, locations, and profiles will be determined in part by the specific intended application and use environment. In addition, in the embodiment described below, the same reference numerals are used in common between different drawings to denote the same parts or parts having the same function, and repeated description thereof may be omitted. In this specification, like numerals and letters are used to refer to like items, so once an item is defined in one figure, it need not be discussed further in subsequent figures.
实施例一Example 1
本实施例提供了一种吸取器械,具体地,请参见附图1至附图3,其中,图1为本发明一实施例提供的吸取器械的喇叭口处于收缩状态时结构示意图;图2为本发明一实施例提供的吸取器械的喇叭口处于半扩张状态时结构示意图;图3为本发明一实施例提供的吸取器械的喇叭口处于扩张状态时的结构示意图;结合图1至图3可以明显看出,所述吸取器械包括输送管路100、推送装置400和沿径向方向可自适应调节尺寸的喇叭口200;其中,所述喇叭口200的小口端连接所述输送管路100的远端;所述推送装置400通过所述输送管路100的近端伸入所述输送管路100和所述喇叭口200内部,且所述推送装置400的远端可拆卸的与所述喇叭口200的大口端连接,所述推送装置400被配置为带动所述喇叭口200沿所述输送管路300的轴向移动。This embodiment provides a suction device. Specifically, please refer to Figures 1 to 3, wherein Figure 1 is a schematic structural diagram of the suction device provided by an embodiment of the present invention when the bell mouth is in a contracted state; Figure 2 is a Figure 3 is a schematic structural diagram of the bell mouth of the suction device provided by an embodiment of the present invention when the bell mouth is in a semi-expanded state; It is obvious that the suction device includes a
如此设置,本发明通过将所述吸取器械在输送过程中保持受力收缩状态,使得所述吸取器械在输送过程时的整体尺寸以及输送阻力减小,便于将所述吸取器械运送至病灶处。当所述吸取器械到达病灶后,通过推动所述推送装置400将所述喇叭口200推出受力范围,使得所述喇叭口200在无径向作用力的情况下逐渐扩张呈喇叭型,所述喇叭口200在扩张过程中能够顺应血管500内壁尺寸自动调节大小并最终达到紧贴血管500内壁的效果,由此保障了在后续抽吸过程中血管500内血液和血栓600无其他通道可走,只能通过所述吸取器械流出,从而减少病灶处血栓600逃逸的可能。同时在利用所述吸取器械进行血栓600抽吸时,由于所述喇叭口200紧贴所述血管500内壁,所述喇叭口200与所述血管500内壁之间无空隙,因此所述吸取器械在同等抽吸压力下无压力损失,从而增大了吸取器械的抽吸压差,使得所述吸取器械在抽吸过程中能够所以将大小血栓全部抽吸完全,进一步减少血栓600逃逸后造成其他血管500栓塞的可能。In this way, the present invention maintains the suction device in a force-contracted state during the delivery process, so that the overall size and delivery resistance of the suction device during the delivery process are reduced, which facilitates the delivery of the suction device to the lesion. After the suction device reaches the lesion, the
优选的,所述喇叭口200包括弹性本体和设置在所述弹性本体内的支撑结构201;其中,所述支撑结构201被配置为,在无外力作用时能够使得所述弹性本体呈喇叭状。由此,当所述喇叭口200扩张呈喇叭型后,所述吸取器械开始进行血栓600吸取工作时,所述支撑结构201能够为所述喇叭口200提供支撑力,保障所述喇叭口200在血栓600吸取过程能够保持稳定的状态。在其中一种优选实施方式中,所述弹性本体的材质包括:聚四氟乙烯、聚酰胺、聚氨酯、聚醚嵌段酰胺和/或硅橡胶等弹性材质,由此,所述喇叭口200才能够沿径向自适应调节形状。Preferably, the
请继续参见图1至图3,从图中可以看出,所述支撑结构201包括一组远端支撑段、一组近端支撑段以及设置在所述远端支撑段和所述近端支撑段之间的至少一组中间支撑段,每组支撑段包括至少两根半径和弧长相等的圆弧段;其中,所述远端支撑段位于所述喇叭口200的大口端,所述近端支撑段位于所述喇叭口200的小口端;所述远端支撑段的圆弧段的半径和弧长大于所述中间支撑段的圆弧段的半径和弧长,所述中间支撑段的圆弧段的半径和弧长大于所述近端支撑段的圆弧段的半径和弧长,从所述喇叭口200的大口端至小口端,所述中间支撑段的圆弧段的半径和弧长依次减小;任意一组所述支撑段的圆弧段沿所述喇叭口200的轴向方向错位对称排布,且在无沿径向向内的作用力时形成一不闭合圆环。在其中一种优选实施方式中,所述支撑结构201的材质包括:镍钛合金和/或不锈钢,其中,由镍钛合金制成的金属丝可以通过激光切割方式成型为不同的圆弧半径,较佳地,所述金属丝切割为半圆弧段,再经过高温热定型处理,保持其形状记忆性能。由于所述任一支撑段内的两个金属丝圆弧段组成非完整圆形且具有一定弹性,当所述吸取器械到达病灶处后,通过所述推送装置400将所述喇叭口200沿轴向推动,所述喇叭口200逐级翻转打开,所述喇叭口200的形态由图1至图2并最终转化为图3的喇叭型。且当血管500内壁半径大于金属丝圆弧段半径时,所述金属丝圆弧段达到其赋予的弧度,为其最大张开角度,此时,所述金属丝圆弧段上无张力,其作用是逐渐打开所述喇叭口200,实现所述喇叭口200由小到大的渐变过渡;当血管500内壁半径小于金属丝圆弧半径时,金属丝被压缩,产生向外的张力,该张力使金属丝紧贴血管500内壁,可通过调节圆弧半径的大小,调节贴合的张力。因此本实施例能够通过改变金属丝的圆弧半径,使其能够灵活的顺应血管500内壁的大小伸缩,从而紧贴血管500内壁。Please continue to refer to FIG. 1 to FIG. 3 , it can be seen from the figures that the
优选的,所述远端支撑段包括的圆弧段的半径>血管500内壁半径。根据Hagen–Poiseuille Law,体积流量正比于比压降和管半径的四次方,Q=π×r^4×Δp/(8ηL),因此当所述喇叭口200自顺应血管500内壁打开时,所述喇叭口200的大口端半径达到最大值。由金属丝制成的所述远端支撑段包括的两个圆弧段,顺应血管500内壁的半径尺寸并因为张力紧贴血管500内壁,使得在负压抽吸时候,无压力损失,抽吸压差达到最大,从而利于血栓600抽吸。在其中一种优选实施方式中,所述近端支撑段包括的圆弧段的半径与所述输送管路100的半径相同。由此,实现了所述输送管路100内壁至所述喇叭口200内壁的平滑过渡,保障血栓600的顺利取出。Preferably, the radius of the arc segment included in the distal support segment is greater than the radius of the inner wall of the
优选的,所述推送装置400包括至少两根推送杆,所述两根推送杆的远端和所述喇叭口200的大口端可分离连接,且所述推送杆关于所述喇叭口200的中轴线对称。如此设置,保障了当利用所述推送杆将所述喇叭口200推出所述输送管路100时,所述喇叭口200受力均匀,且同时向外翻转扩张成喇叭型。需要进一步说明的是,所述推送杆包括由镍钛合金、不锈钢、尼龙等材料制成。每根所述收缩杆可以由单丝或是多丝构成,优选为单丝构成。Preferably, the pushing
优选的,还包括电解脱分离装置,所述两根推送杆的远端与所述喇叭口200相连处设有电解脱点401,所述电解脱分离装置用于将所述两根推送杆从所述喇叭口200的所述电解脱点401处脱离。由此,当所述喇叭口200扩张为喇叭型后,所述吸取器械开始进行取栓操作前,通过移除所述推送杆,能够减少推送杆体积对内腔体积的影响,从而使输送管路100内腔达到最大值且内腔顺滑,减少凝血块输送过程中的阻力。需要进一步说明的是,通过电解脱分离装置将所述推送杆从所述喇叭口200中移除的方式并不是唯一的,本发明还可以通过机械解脱的方式移除所述推送杆。Preferably, it also includes an electrolytic decoupling and separation device, and an
优选的,所述输送管路100和/或所述喇叭口200的外壁还包括润滑层。由此,能够减少将所述输送管路100推出指引导管或是将所述吸取器械从血管500内撤出时产生的摩擦力。其中,所述润滑层分包括:水溶性大分子、水性表面活性剂、水性粘合剂和去离子水。水溶性大分子选用聚丙烯酰胺、聚乙烯吡咯烷酮、聚乙二醇,优先选用聚乙烯吡咯烷酮溶液。所述润滑层可以采用喷涂、浸涂、涂刷等方式涂覆。Preferably, the outer wall of the conveying
实施例二Embodiment 2
本实施例提供了一种吸取器械的制作方法,包括制作上述的吸取器械,具体制作步骤如下:The present embodiment provides a method for making a suction device, including making the above-mentioned suction device, and the specific fabrication steps are as follows:
利用锥型模具加工一层PTFE材料作为所述喇叭口200的内层;Utilize a tapered mold to process a layer of PTFE material as the inner layer of the
沿着所述锥形模具由小至大的方向,依次间隔固定距离,在所述锥形模具的小端固定所述近端支撑段,在所述锥形模具的大端固定远端支撑段,在所述锥形模具的小端与大端之间固定至少一种中间支撑段,每组支撑段包括的圆弧段错位对称排布;Along the direction of the tapered mold from small to large, at fixed distances in turn, fix the proximal support section at the small end of the tapered mold, and fix the distal support section at the large end of the tapered mold , at least one intermediate support segment is fixed between the small end and the large end of the conical die, and the arc segments included in each group of support segments are dislocated and symmetrically arranged;
加工Pebax材料作为所述喇叭口200的外层;Process the Pebax material as the outer layer of the
固定所述喇叭口200的内层、所述每组支撑段和所述喇叭口200的外层;Fixing the inner layer of the
将所述推送装置400的远端伸入所述输送管路100和所述喇叭口200内并与所述喇叭口200的大口端连接。The distal end of the pushing
由于本发明提供的制作方法用于制作所述吸取器械,因此制成的所述吸取器械至少具有相同的技术效果,在此就不一一赘述。Since the manufacturing method provided by the present invention is used to manufacture the suction device, the manufactured suction device has at least the same technical effect, and details are not repeated here.
在其中一种优选实施方式中,将采用5组长度和半径不同的支撑段,具体地,请结合图3及下表:In one of the preferred embodiments, 5 groups of support sections with different lengths and radii will be used. Specifically, please refer to Figure 3 and the following table:
表一:每组支撑段的长度和圆弧半径数值Table 1: Length and arc radius values of each group of support segments
在本实施方式中,每一支撑段包括2根长度和圆弧半径相同的金属丝圆弧段,总计10根金属丝圆弧段。所述吸取器械的制作方式包括:利用锥型模具加工一层PTFE材料作为所述喇叭口200内层,随后沿着锥形模具由小至大的方向,依次两侧间隔固定距离,错位对称固定5mm、6mm、7mm、8mm、9mm的镍钛金属丝。完成后,加工Pebax材料作为所述喇叭口200外层,再使用热烘枪通过热塑方式将三层结构固定。再利用微量移液枪将1毫升的聚乙烯吡咯烷酮(PVP)润滑溶液均匀涂覆于所述输送管路100和所述喇叭口200的外层,并将其放置于通风橱内进行干燥,即完成外层涂覆。第五支撑段即为所述近端支撑段,所述第五支撑段的半径与输送管路100的半径相关联,使得所述输送管路100内壁至所述喇叭口200的平滑过渡。随后取两根直径为0.2毫米的镍钛合金长丝,做为推送装置400,两根推送丝对称式分布,两根推送丝的远端固定于所述喇叭口200的大口端,且带有电解脱分离装置。将制成后的所述吸取器械运送到达血管500内病灶部位时,利用所述推送丝向所述喇叭口200的大口端推送,完成所述喇叭口200打开,如图3所示。所述喇叭口200完全放置到指定部位后,通过电解脱方式,将推送丝和所述喇叭口200的大口端解脱分离,撤走推送丝,由此增大输送部件内腔体积,减少输送过程中的阻力。并在所述输送管路100的近端接上抽吸泵,给定抽吸负压值,此时实现了抽吸口面积和压降都较大,从而使抽吸流量和抽吸力都较大,并有利于血管500中凝血块的顺利抽出。待抽吸完成后,回撤所述吸取器械,由于所述喇叭口200能够自适应血管500尺寸,且回撤路径中血管500半径也逐渐增大,因此可实现吸取器械的轻松回撤。In this embodiment, each support segment includes 2 wire arc segments with the same length and arc radius, and a total of 10 wire arc segments. The manufacturing method of the suction device includes: using a tapered mold to process a layer of PTFE material as the inner layer of the
实施例三Embodiment 3
本实施例提供一种吸取器械的使用方法,具体使用步骤如下:The present embodiment provides a method of using a suction device, and the specific use steps are as follows:
利用指引导管将所述吸取器械运送至血管内病灶处;using the guiding catheter to transport the suction device to the intravascular lesion;
向所述推送装置400的远端方向推动所述喇叭口200,直至所述推送装置400将所述喇叭口200推出所述输送管路100并与所述血管内壁贴合;Pushing the
将所述推送装置400和所述喇叭口200的大口端分离,并移除所述推送装置400;Separate the pushing
通过所述输送管路100的近端向所述吸取器械施加抽吸力进行抽吸。A suction force is applied to the suction instrument through the proximal end of the
由于本发明提供的使用方法是采用上述的吸取器械进行抽吸工作,因此至少具有相同的技术效果,在此就不一一赘述。Since the use method provided by the present invention uses the above-mentioned suction device to perform the suction work, it has at least the same technical effect, and will not be repeated here.
请参见附图4,图4为本发明一实施例提供的吸取器械吸取血栓的过程示意图;在其中一种优选实施方式中,将在颈内动脉血管500模型中进行测试,模拟的动脉直径为5mm。先使用指引导管建立通路,将血管500内凝块的吸取器械输送至含有凝血块的病灶部位,离病灶部位保留3-5mm间距(如4A),调整定位后,往所述喇叭口200的大口端方向推送镍钛合金丝制成的推送杆,使所述喇叭口200完全打开,并且所述喇叭口200的大口端自适应紧贴在颈内动脉上。因为第三支撑段包括的圆弧段半径与血管500内壁半径相等,在所述第一支撑段至所述第三支撑段,所述喇叭口200的最大半径都等于血管500半径(如4B)。随后将电解脱器连接上推送杆,并等待1至2分钟至所述喇叭口200与推送杆成功完成脱离后撤走推送杆(如4C)。将输送管路100的近端连接抽吸泵,在负压下,凝血块随血流经过喇叭口200,进入输送管路100内,并抽出体外(如4D)。随后将输送导管抽出体外。在本实施方式中,能够将所述血栓600从病灶处完全吸取出,避免了碎小血栓的逃逸。Please refer to FIG. 4 . FIG. 4 is a schematic diagram of the process of sucking a thrombus by a suction device according to an embodiment of the present invention; in one of the preferred embodiments, the test will be performed in the internal
本发明提供的吸取器械的使用方法为使用上述的吸取器械,以及利用本发明提供的吸取器械的制作方法制作的上述吸取器械,都是通过所述吸取器械进行抽吸工作,因此至少具有相同的技术效果,在此就不一一赘述。The use method of the suction device provided by the present invention is to use the above-mentioned suction device, and the above-mentioned suction device manufactured by using the method for manufacturing the suction device provided by the present invention all perform suction work through the suction device, so at least the same The technical effects will not be repeated here.
在本说明书的描述中,参考术语“一个实施例”、“一些实施例”、“示例”、“具体示例”、或“一些示例”等的描述意指结合该实施例或示例描述的具体特征、结构、材料或者特点包含于本发明的至少一个实施例或示例中。在本说明书中,对上述术语的示意性表述不必须针对的是相同的实施例或示例。In the description of this specification, description with reference to the terms "one embodiment," "some embodiments," "example," "specific example," or "some examples", etc., mean specific features described in connection with the embodiment or example , structure, material or feature is included in at least one embodiment or example of the present invention. In this specification, schematic representations of the above terms are not necessarily directed to the same embodiment or example.
综上,本发明通过将所述吸取器械在输送过程中保持受力收缩状态,使得所述吸取器械在输送过程时的整体尺寸以及输送阻力减小,便于将所述吸取器械运送至病灶处。当所述吸取器械到达病灶后,通过推动所述推送装置400将所述喇叭口200推出受力范围,使得所述喇叭口200在无径向作用力的情况下逐渐扩张呈喇叭型,所述喇叭口200在扩张过程中能够顺应血管500内壁尺寸自动调节大小并最终达到紧贴血管500内壁的效果,由此保障了在后续抽吸过程中血管500内血液和血栓600无其他通道可走,只能通过所述吸取器械流出,从而减少病灶处血栓600逃逸的可能。同时在利用所述吸取器械进行血栓600抽吸时,由于所述喇叭口200紧贴所述血管500内壁,所述喇叭口200与所述血管500内壁之间无空隙,因此所述吸取器械在同等抽吸压力下无压力损失,从而增大了吸取器械的抽吸压差,使得所述吸取器械在抽吸过程中能够所以将大小血栓全部抽吸完全,进一步减少血栓600逃逸后造成其他血管500栓塞的可能。To sum up, in the present invention, by maintaining the suction device in a force-contracted state during the delivery process, the overall size and delivery resistance of the suction device during the delivery process are reduced, which facilitates the delivery of the suction device to the lesion. After the suction device reaches the lesion, the
本发明提供的吸取器械的使用方法为使用上述的吸取器械,以及利用本发明提供的吸取器械的制作方法制作的上述吸取器械,都是通过所述吸取器械进行抽吸工作,因此至少具有相同的技术效果,在此就不一一赘述。The use method of the suction device provided by the present invention is to use the above-mentioned suction device, and the above-mentioned suction device manufactured by using the method for manufacturing the suction device provided by the present invention all perform suction work through the suction device, so at least the same The technical effects will not be repeated here.
上述仅为本发明的优选实施例而已,并不对本发明起到任何限制作用。任何所属技术领域的技术人员,在不脱离本发明的技术方案的范围内,对本发明揭露的技术方案和技术内容做任何形式的等同替换或修改等变动,均属未脱离本发明的技术方案的内容,仍属于本发明的保护范围之内。The above are only preferred embodiments of the present invention, and do not have any limiting effect on the present invention. Any person skilled in the art, within the scope of not departing from the technical solution of the present invention, makes any form of equivalent replacement or modification to the technical solution and technical content disclosed in the present invention, all belong to the technical solution of the present invention. content still falls within the protection scope of the present invention.
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