CN116173386B - Shock wave balloon catheter - Google Patents
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- CN116173386B CN116173386B CN202310354009.1A CN202310354009A CN116173386B CN 116173386 B CN116173386 B CN 116173386B CN 202310354009 A CN202310354009 A CN 202310354009A CN 116173386 B CN116173386 B CN 116173386B
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M25/1002—Balloon catheters characterised by balloon shape
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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
- A61B17/22004—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 using mechanical vibrations, e.g. ultrasonic shock waves
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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
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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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- 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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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M2025/1043—Balloon catheters with special features or adapted for special applications
- A61M2025/109—Balloon catheters with special features or adapted for special applications having balloons for removing solid matters, e.g. by grasping or scraping plaque, thrombus or other matters that obstruct the flow
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Abstract
Description
技术领域Technical Field
本申请涉及医疗器械技术领域,尤其涉及一种冲击波球囊导管。The present application relates to the technical field of medical devices, and in particular to a shock wave balloon catheter.
背景技术Background Art
长期以来,心血管病都是造成患者死亡的重要原因之一。球囊扩张血管成形术在减少阻塞性冠状动脉疾病发病和死亡的过程中发挥了重要作用,已经成为了世界各国治疗冠心病的最常用方式;与此同时,球囊扩张血管成形术也是外周动脉疾病患者血运重建的主要方式。Cardiovascular disease has long been one of the major causes of death. Balloon angioplasty has played an important role in reducing the incidence and mortality of obstructive coronary artery disease and has become the most commonly used method for treating coronary heart disease in countries around the world. At the same time, balloon angioplasty is also the main method for revascularization in patients with peripheral artery disease.
对于传统的导管介入治疗技术,临床通常采用经皮腔内血管成形术(PTA)来打开动静脉血管中的狭窄、钙化等病灶。当球囊膨胀扩展血管壁中的堵塞病灶时,球囊会逐渐释放压力,直至斑块破裂;但与此同时,斑块碎片未及时清理,容易给手术造成其他风险。For traditional catheter interventional treatment technology, percutaneous transluminal angioplasty (PTA) is usually used clinically to open stenosis, calcification and other lesions in arteries and veins. When the balloon expands the blocked lesions in the blood vessel wall, the balloon will gradually release pressure until the plaque ruptures; but at the same time, if the plaque fragments are not cleaned up in time, it is easy to cause other risks to the operation.
发明内容Summary of the invention
本申请提供了一种冲击波球囊导管,能够将病变部位完全打通,且能回收处理病变斑块,避免术中并发症的产生。The present application provides a shock wave balloon catheter that can completely open up the diseased area and recover and treat the diseased plaque to avoid the occurrence of intraoperative complications.
本申请实施例提供了一种冲击波球囊导管,包括:The present application provides a shock wave balloon catheter, comprising:
第一导管,所述第一导管具有第一端和第二端,所述第一导管设置有沿所述第一导管的轴向延伸的内通道,所述第一端设置有连通所述内通道与所述内通道外部空间的第一内管口,所述第二端设置有连通所述内通道与所述内通道外部空间的第二内管口,所述内通道还连通有抽吸单元;A first conduit, the first conduit having a first end and a second end, the first conduit being provided with an inner channel extending along the axial direction of the first conduit, the first end being provided with a first inner pipe opening connecting the inner channel with a space outside the inner channel, the second end being provided with a second inner pipe opening connecting the inner channel with a space outside the inner channel, and the inner channel being further connected with a suction unit;
球囊,所述球囊套设于所述第二端,所述球囊与所述第一导管之间设置有注液腔;A balloon, wherein the balloon is sleeved on the second end, and an injection cavity is provided between the balloon and the first catheter;
第二导管,所述第二导管位于所述球囊靠近所述第一端的一侧,所述第二导管套设于所述第一导管,所述第二导管设置有与所述注液腔相连通的注液通道;a second catheter, the second catheter being located at a side of the balloon close to the first end, the second catheter being sleeved on the first catheter, and the second catheter being provided with an injection channel communicating with the injection cavity;
声波发射单元,所述声波发射单元设置在所述注液腔内,所述声波发射单元用于在所述注液腔内生成沿背离所述第一端方向的冲击波;及an acoustic wave emitting unit, the acoustic wave emitting unit being disposed in the liquid injection cavity, the acoustic wave emitting unit being used to generate a shock wave in the liquid injection cavity in a direction away from the first end; and
移动丝,所述移动丝可转动地设于所述内通道,所述移动丝具有末端和前端,所述末端经所述第一内管口延伸至所述内通道的外部空间,所述前端设置有螺旋部,所述螺旋部的轴线平行于所述第一导管的轴向,所述螺旋部可沿所述第一导管的轴向经所述第二内管口移动至所述内通道的外部空间。A moving wire, the moving wire is rotatably arranged in the inner channel, the moving wire has an end and a front end, the end extends to the external space of the inner channel through the first inner tube opening, the front end is provided with a spiral portion, the axis of the spiral portion is parallel to the axial direction of the first conduit, and the spiral portion can move along the axial direction of the first conduit through the second inner tube opening to the external space of the inner channel.
在其中一些实施例中,所述移动丝设置有导引部,所述导引部位于所述螺旋部背离所述末端的一侧。In some embodiments, the moving wire is provided with a guide portion, and the guide portion is located on a side of the spiral portion away from the end.
在其中一些实施例中,所述移动丝还设置有连接部,所述螺旋部位于所述导引部和所述连接部之间,所述连接部与所述螺旋部相连接。In some embodiments, the moving wire is further provided with a connecting portion, the spiral portion is located between the guiding portion and the connecting portion, and the connecting portion is connected to the spiral portion.
在其中一些实施例中,所述螺旋部绕设于所述前端;或者,所述螺旋部的一端与所述前端相连接。In some embodiments, the spiral portion is wound around the front end; or, one end of the spiral portion is connected to the front end.
在其中一些实施例中,所述螺旋部沿垂直于所述螺旋部轴线方向的横截面为矩形,且所述矩形的边角设置为倒角。In some embodiments, a cross section of the spiral portion along a direction perpendicular to an axis of the spiral portion is rectangular, and corners of the rectangle are chamfered.
在其中一些实施例中,所述螺旋部的螺距为0.80mm-1.50mm。In some embodiments, the pitch of the spiral portion is 0.80 mm-1.50 mm.
在其中一些实施例中,所述螺旋部的圈数大于或等于2且小于或等于5。In some embodiments, the number of turns of the spiral portion is greater than or equal to 2 and less than or equal to 5.
在其中一些实施例中,所述声波发射单元包括:In some embodiments, the sound wave emitting unit comprises:
两个电极头,两个所述电极头之间的距离小于或等于0.6mm;Two electrode tips, the distance between the two electrode tips is less than or equal to 0.6 mm;
脉冲电源,所述脉冲电源与所述电极头通过导线电性连接,所述导线的表面涂覆有绝缘层。A pulse power supply is electrically connected to the electrode head through a wire, and a surface of the wire is coated with an insulating layer.
在其中一些实施例中,所述冲击波球囊导管还包括与所述末端相连的移动单元,所述移动单元用于带动所述移动丝围绕所述螺旋部的轴线转动,且所述移动单元用于带动所述移动丝沿所述第一导管的轴向往复移动。In some embodiments, the shock wave balloon catheter further comprises a moving unit connected to the distal end, the moving unit being used to drive the moving wire to rotate around the axis of the spiral portion, and the moving unit being used to drive the moving wire to reciprocate along the axial direction of the first catheter.
在其中一些实施例中,所述移动单元包括:In some embodiments, the mobile unit comprises:
旋转动力件,所述旋转动力件与所述末端相连接,所述旋转动力件用于带动所述移动丝围绕所述螺旋部的轴线转动;A rotating power member connected to the end, the rotating power member is used to drive the moving wire to rotate around the axis of the spiral portion;
伸缩动力件,所述伸缩动力件具有伸缩端,所述伸缩端与所述旋转动力件相连接,所述伸缩动力件用于带动所述旋转动力件和所述移动丝共同沿所述第一导管的轴向往复移动。A telescopic power member, wherein the telescopic power member has a telescopic end, wherein the telescopic end is connected to the rotating power member, and the telescopic power member is used to drive the rotating power member and the moving wire to move back and forth along the axial direction of the first conduit.
本申请实施例提供的冲击波球囊导管,有益效果在于:由于第一导管的内通道连通有抽吸单元,球囊与第一导管之间设置有注液腔,注液腔内的声波发射单元用于在注液腔内生成冲击波,且设置在移动丝前端的螺旋部可经第二内管口移动至内通道的外部空间,所以在处理血管内堵塞病变时,可以先将第一导管和球囊送至病变部位,然后通过声波发射单元向外输出非聚焦的冲击波,产生压缩应力,压裂病变部位的病变斑块,在完成冲击波治疗后,再将螺旋部移动至病变部位,并启动抽吸单元的抽吸功能,螺旋部在绕随移动丝一起旋转的同时,还可以沿第一导管的轴向往复移动,不仅可以更好地裂解病变斑块,而且还可以将已经裂解的病变斑块带入内通道并通过抽吸单元导出体外,最后再用球囊对病变部位进行扩张即可完成治疗过程。本申请实施例提供的冲击波球囊导管,对病变的治疗效果更好,且能回收处理病变物质,避免术中并发症的产生。The shock wave balloon catheter provided in the embodiment of the present application has the beneficial effect that: since the inner channel of the first catheter is connected to the suction unit, an injection cavity is arranged between the balloon and the first catheter, the sound wave emission unit in the injection cavity is used to generate shock waves in the injection cavity, and the spiral portion arranged at the front end of the moving wire can be moved to the external space of the inner channel through the second inner tube opening. Therefore, when treating blocked lesions in blood vessels, the first catheter and the balloon can be first sent to the lesion site, and then the non-focused shock wave is output outwardly through the sound wave emission unit to generate compression stress and fracture the lesion plaque in the lesion site. After completing the shock wave treatment, the spiral portion is moved to the lesion site, and the suction function of the suction unit is started. While the spiral portion rotates around the moving wire, it can also reciprocate along the axial direction of the first catheter, which can not only better lyse the lesion plaque, but also bring the lysed lesion plaque into the inner channel and guide it out of the body through the suction unit. Finally, the lesion site is expanded with the balloon to complete the treatment process. The shock wave balloon catheter provided in the embodiment of the present application has a better therapeutic effect on lesions and can recover and process lesion materials to avoid the occurrence of intraoperative complications.
附图说明BRIEF DESCRIPTION OF THE DRAWINGS
为了更清楚地说明本申请实施例中的技术方案,下面将对实施例或现有技术描述中所需要使用的附图作简单地介绍,显而易见地,下面描述中的附图仅仅是本申请的一些实施例,对于本领域普通技术人员来讲,在不付出创造性劳动性的前提下,还可以根据这些附图获得其他的附图。In order to more clearly illustrate the technical solutions in the embodiments of the present application, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present application. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative labor.
图1是本申请其中一个实施例中冲击波球囊导管的立体结构示意图;FIG1 is a schematic diagram of the three-dimensional structure of a shock wave balloon catheter in one embodiment of the present application;
图2是图1所示的冲击波球囊导管去除移动丝后的立体结构示意图;FIG2 is a schematic diagram of the three-dimensional structure of the shock wave balloon catheter shown in FIG1 after removing the moving wire;
图3是图1所示的冲击波球囊导管去除移动丝后的主视图;FIG3 is a front view of the shock wave balloon catheter shown in FIG1 after the moving wire is removed;
图4是图1所示的冲击波球囊导管中的声波发射单元的立体结构示意图;FIG4 is a schematic diagram of the three-dimensional structure of the sound wave emitting unit in the shock wave balloon catheter shown in FIG1 ;
图5是图1所示的冲击波球囊导管中的移动丝的立体结构示意图;FIG5 is a schematic diagram of the three-dimensional structure of the moving wire in the shock wave balloon catheter shown in FIG1 ;
图6是图5所示的移动丝中的螺旋部沿垂直于螺旋部轴线的横截面示意图;FIG6 is a schematic cross-sectional view of the spiral portion of the moving wire shown in FIG5 along a direction perpendicular to the axis of the spiral portion;
图7中的(a)是图1所示的冲击波球囊导管在血管内堵塞病变位置的示意图;FIG. 7 (a) is a schematic diagram of the shock wave balloon catheter shown in FIG. 1 blocking the lesion position in the blood vessel;
图7中的(b)是图1所示的冲击波球囊导管在血管内堵塞病变进行冲击波治疗的示意图;FIG. 7 ( b ) is a schematic diagram of the shock wave balloon catheter shown in FIG. 1 performing shock wave treatment on an obstructed lesion in a blood vessel;
图7中的(c)是图1所示的冲击波球囊导管在血管内处理压裂的病变斑块的示意图;FIG. 7 ( c ) is a schematic diagram of the shock wave balloon catheter shown in FIG. 1 treating a fractured lesion plaque in a blood vessel;
图8是本申请另一个实施例中冲击波球囊导管的立体结构示意图。FIG8 is a schematic diagram of the three-dimensional structure of a shock wave balloon catheter in another embodiment of the present application.
图中标记的含义为:The meanings of the marks in the figure are:
100、冲击波球囊导管;100. Shock wave balloon catheter;
10、第一导管;11、第一端;12、第二端;13、内通道;14、第一内管口;15、第二内管口;10. first conduit; 11. first end; 12. second end; 13. inner passage; 14. first inner pipe opening; 15. second inner pipe opening;
20、球囊;21、注液腔;22、固定部;20. Balloon; 21. Liquid injection cavity; 22. Fixing part;
30、第二导管;31、注液通道;30. Second conduit; 31. Liquid injection channel;
40、声波发射单元;401、冲击波;41、电极头;42、导线;43、绝缘层;40. Acoustic wave emitting unit; 401. Shock wave; 41. Electrode head; 42. Wire; 43. Insulating layer;
50、移动丝;51、末端;52、前端;53、螺旋部;54、导引部;541、尖端;55、连接部;50, moving wire; 51, end; 52, front end; 53, spiral part; 54, guide part; 541, tip; 55, connecting part;
60、显影环;60. Development ring;
200、血管。200. Blood vessels.
具体实施方式DETAILED DESCRIPTION
为了使本申请的目的、技术方案及优点更加清楚明白,以下结合附图及实施例,对本申请进行进一步详细说明。应当理解,此处所描述的具体实施例仅用以解释本申请,并不用于限定本申请。In order to make the purpose, technical solution and advantages of the present application more clearly understood, the present application is further described in detail below in conjunction with the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are only used to explain the present application and are not used to limit the present application.
需要说明的是,当元件被称为“固定于”或“设置于”另一个元件,它可以直接在另一个元件上或者间接在该另一个元件上。当一个元件被称为是“连接于”另一个元件,它可以是直接连接到另一个元件或间接连接至该另一个元件上。It should be noted that when an element is referred to as being "fixed to" or "disposed on" another element, it can be directly on the other element or indirectly on the other element. When an element is referred to as being "connected to" another element, it can be directly connected to the other element or indirectly connected to the other element.
此外,术语“第一”、“第二”仅用于描述目的,而不能理解为指示或暗示相对重要性或者隐含指明所指示的技术特征的数量。由此,限定有“第一”、“第二”的特征可以明示或者隐含地包括一个或者更多个该特征。在本申请的描述中,“多个”的含义是两个或两个以上,除非另有明确具体的限定。In addition, the terms "first" and "second" are used for descriptive purposes only and should not be understood as indicating or implying relative importance or implicitly indicating the number of the indicated technical features. Therefore, a feature defined as "first" or "second" may explicitly or implicitly include one or more of the features. In the description of this application, the meaning of "plurality" is two or more, unless otherwise clearly and specifically defined.
在本申请说明书中描述的参考“一个实施例”、“一些实施例”或“实施例”意味着在本申请的一个或多个实施例中包括结合该实施例描述的特定特征、结构或特点。由此,在本说明书中的不同之处出现的语句“在一个实施例中”、“在一些实施例中”、“在其他一些实施例中”、“在另外一些实施例中”等不是必然都参考相同的实施例,而是意味着“一个或多个但不是所有的实施例”,除非是以其他方式另外特别强调。此外,在一个或多个实施例中,可以以任何合适的方式组合特定的特征、结构或特性。References to "one embodiment", "some embodiments" or "an embodiment" described in the specification of this application mean that a particular feature, structure or characteristic described in conjunction with the embodiment is included in one or more embodiments of the present application. Thus, the phrases "in one embodiment", "in some other embodiments", "in some other embodiments", etc., which appear at different places in this specification, do not necessarily refer to the same embodiment, but mean "one or more but not all embodiments", unless otherwise specifically emphasized in other ways. In addition, in one or more embodiments, particular features, structures or characteristics may be combined in any suitable manner.
为了说明本申请的技术方案,下面结合具体附图及实施例来进行说明。In order to illustrate the technical solution of the present application, a description is given below with reference to specific drawings and embodiments.
请参考图1、图2和图3,本申请实施例提供了一种冲击波球囊导管100,包括第一导管10、球囊20、第二导管30、声波发射单元40和移动丝50。Please refer to FIG. 1 , FIG. 2 and FIG. 3 , an embodiment of the present application provides a shock wave balloon catheter 100 , including a first catheter 10 , a balloon 20 , a second catheter 30 , a sound wave emitting unit 40 and a moving wire 50 .
第一导管10具有第一端11和第二端12,第一导管10设置有沿第一导管10的轴向延伸的内通道13,第一端11设置有连通内通道13与内通道13外部空间的第一内管口14,第二端12设置有连通内通道13与内通道13外部空间的第二内管口15,内通道13还连通有抽吸单元(图中未示出)。The first conduit 10 has a first end 11 and a second end 12. The first conduit 10 is provided with an inner channel 13 extending along the axial direction of the first conduit 10. The first end 11 is provided with a first inner pipe opening 14 connecting the inner channel 13 with the external space of the inner channel 13. The second end 12 is provided with a second inner pipe opening 15 connecting the inner channel 13 with the external space of the inner channel 13. The inner channel 13 is also connected with a suction unit (not shown in the figure).
可以理解的是,抽吸单元可以包括抽吸泵和电磁阀等,抽吸单元能够产生负压,从而将内通道13里面的物质吸出。抽吸单元可以通过第一内管口14与内通道13连通,或者,抽吸单元还可通过与第一导管10的其他部位与内通道13连通。It is understandable that the suction unit may include a suction pump and a solenoid valve, etc. The suction unit can generate negative pressure to suck out the material in the inner channel 13. The suction unit can be connected to the inner channel 13 through the first inner pipe port 14, or the suction unit can be connected to the inner channel 13 through other parts of the first conduit 10.
球囊20套设于第二端12,如球囊20套设于靠近第一导管10的第二端12位置的外壁上,球囊20与第一导管10之间设置有注液腔21。The balloon 20 is sleeved on the second end 12 , for example, the balloon 20 is sleeved on the outer wall near the second end 12 of the first catheter 10 , and an injection cavity 21 is provided between the balloon 20 and the first catheter 10 .
可以理解的是,注液腔21可以用于容纳水、盐水、造影剂或其混合液体等,当向注液腔21内通入液体时,球囊20会发生膨胀。本实施例中,球囊20为OTW(Over The Wire,同轴整体交换)型。It is understandable that the injection cavity 21 can be used to contain water, saline, contrast agent or a mixed liquid thereof, and the balloon 20 will expand when liquid is introduced into the injection cavity 21. In this embodiment, the balloon 20 is an OTW (Over The Wire) type.
其中,可以在球囊20的一端设置固定部22,球囊20、固定部22和第一导管10采用激光焊接的方式或其他方式连接一起。A fixing portion 22 may be provided at one end of the balloon 20 , and the balloon 20 , the fixing portion 22 and the first catheter 10 are connected together by laser welding or other methods.
第二导管30位于球囊20靠近第一端11的一侧,第二导管30套设于第一导管10,第二导管30设置有与注液腔21相连通的注液通道31。The second catheter 30 is located at a side of the balloon 20 close to the first end 11 . The second catheter 30 is sleeved on the first catheter 10 . The second catheter 30 is provided with an injection channel 31 communicating with the injection cavity 21 .
本申请一实施例中,注液通道31为第二导管30和第一导管10之间的腔道。In one embodiment of the present application, the injection channel 31 is a cavity between the second catheter 30 and the first catheter 10 .
可以理解的是,第二导管30和球囊20也可以采用激光焊接的方式或其他方式连接一起。It is understandable that the second catheter 30 and the balloon 20 may also be connected together by laser welding or other methods.
声波发射单元40设置在注液腔21内,声波发射单元40用于在注液腔21内生成沿背离第一端11方向的冲击波401。The sound wave emitting unit 40 is disposed in the liquid injection cavity 21 , and is used to generate a shock wave 401 in the liquid injection cavity 21 along a direction away from the first end 11 .
可以理解的是,由于声波发射单元40产生的电弧可以在注液腔21的液体中产生沿背离第一端11方向的冲击波401,所以可以在球囊20位于病变部位外侧时,就发射冲击波401压裂病变斑块。例如,请一并参考图4,在本实施例中,声波发射单元40包括脉冲电源(图中未示出)和两个电极头41,两个电极头41之间的距离小于或等于0.6mm,如0.6mm、0.5mm或0.4mm,两个电极头41可以分别设置在第二端12相对的两侧,如两个电极头41可以采用UV胶(Ultraviolet Rays,光敏胶)与第二端12粘连在一起,脉冲电源与电极头41通过导线42电性连接,导线42的表面涂覆有绝缘层43。两个电极头41保持一定距离,以便在脉冲电源输送电压和电流时产生电弧,产生的电弧在注液腔21的液体中产生冲击波401,电极头41的表面产生快速膨胀和坍塌的气泡,从而在注液腔21内产生沿背离第一端11方向的冲击波401。其中,冲击波401的大小可以通过控制脉冲电源输送的脉冲电压的大小、电流、持续时间和重复率来控制,此设计电极头41尺寸小,距离球囊20距离相对远,在达到治疗效果的同时不会对球囊20造成损伤,球囊20的绝缘性可以保护患者免受电击。It is understandable that, since the electric arc generated by the acoustic wave emitting unit 40 can generate a shock wave 401 in the liquid of the injection chamber 21 in a direction away from the first end 11, the shock wave 401 can be emitted to fracture the lesion plaque when the balloon 20 is located outside the lesion site. For example, please refer to FIG. 4 . In this embodiment, the acoustic wave emitting unit 40 includes a pulse power supply (not shown) and two electrode heads 41 . The distance between the two electrode heads 41 is less than or equal to 0.6 mm, such as 0.6 mm, 0.5 mm or 0.4 mm. The two electrode heads 41 can be respectively arranged on opposite sides of the second end 12 . For example, the two electrode heads 41 can be bonded to the second end 12 by UV glue (Ultraviolet Rays, photosensitive glue). The pulse power supply is electrically connected to the electrode head 41 through a wire 42 , and the surface of the wire 42 is coated with an insulating layer 43 . The two electrode heads 41 are kept at a certain distance so that an arc is generated when the pulse power supply transmits voltage and current. The generated arc generates a shock wave 401 in the liquid of the injection cavity 21, and bubbles that expand and collapse rapidly are generated on the surface of the electrode head 41, thereby generating a shock wave 401 in the injection cavity 21 in a direction away from the first end 11. The size of the shock wave 401 can be controlled by controlling the size, current, duration and repetition rate of the pulse voltage transmitted by the pulse power supply. In this design, the electrode head 41 is small in size and relatively far away from the balloon 20. While achieving the treatment effect, it will not cause damage to the balloon 20. The insulation of the balloon 20 can protect the patient from electric shock.
可以理解的是,声波发射单元40接收到放电脉冲后会发生液电效应,使得电能转化为机械能,并向外输出非聚焦的冲击波401,产生压缩应力,进一步压裂病变部位处的病变斑块。It is understandable that after receiving the discharge pulse, the acoustic wave emitting unit 40 will produce a hydroelectric effect, so that the electrical energy is converted into mechanical energy, and a non-focused shock wave 401 is output outward, generating compressive stress, and further fracturing the diseased plaque at the diseased site.
请一并参考图5、图7中的(a)、图7中的(b)和图7中的(c),移动丝50可转动地设于内通道13,移动丝50具有末端51和前端52,末端51经第一内管口14延伸至内通道13的外部空间,前端52设置有螺旋部53,螺旋部53的轴线平行于第一导管10的轴向,螺旋部53可沿第一导管10的轴向经第二内管口15移动至内通道13的外部空间。Please refer to Figures 5, (a), (b) and (c) in Figure 7. The moving wire 50 is rotatably disposed in the inner channel 13. The moving wire 50 has an end 51 and a front end 52. The end 51 extends to the external space of the inner channel 13 through the first inner pipe opening 14, and the front end 52 is provided with a spiral portion 53. The axis of the spiral portion 53 is parallel to the axial direction of the first conduit 10. The spiral portion 53 can move along the axial direction of the first conduit 10 through the second inner pipe opening 15 to the external space of the inner channel 13.
可以理解的是,可以采用人工或自动的方式控制末端51,来使得移动丝50转动且使得移动丝50沿第一导管10的轴向往复移动,而螺旋部53在随移动丝50一起转动的同时,也会沿第一导管10的轴向往复移动,从而可以搅动已经压裂的病变斑块,并将已经裂解的病变斑块带入内通道13且通过抽吸单元导出体外。It is understandable that the end 51 can be controlled manually or automatically to rotate the moving wire 50 and reciprocate along the axial direction of the first catheter 10, and the spiral portion 53 will also reciprocate along the axial direction of the first catheter 10 while rotating with the moving wire 50, thereby stirring the already fractured diseased plaque, and bringing the already lysed diseased plaque into the inner channel 13 and out of the body through the suction unit.
可以理解的是,对于狭窄的病变斑块,冲击波401压裂病变斑块后,病变斑块可能还存在难以自行松散脱落的问题,所以这时候需要先使用螺旋部53来搅动已经压裂的病变斑块,来使其松散脱落,再由抽吸单元通过内管将松散脱落的病变斑块吸出体外。It is understandable that for narrow lesion plaques, after the shock wave 401 fractures the lesion plaque, the lesion plaque may still be difficult to loosen and fall off by itself, so at this time it is necessary to first use the spiral portion 53 to stir the already fractured lesion plaque to make it loose and fall off, and then the suction unit uses the inner tube to suck the loosened and fallen lesion plaque out of the body.
本申请实施例提供的冲击波球囊导管100在手术过程中使用时,先将指引导丝放置于内通道13,冲击波球囊导管100沿着指引导丝达到病变部位,此时,从体外取出指引导丝,指引导丝更换为移动丝50,且将内通道13与抽吸单元连通。When the shock wave balloon catheter 100 provided in the embodiment of the present application is used during surgery, the finger guide wire is first placed in the inner channel 13, and the shock wave balloon catheter 100 reaches the lesion site along the finger guide wire. At this time, the finger guide wire is removed from the body, the finger guide wire is replaced with the moving wire 50, and the inner channel 13 is connected to the suction unit.
需要说明的是,对于螺旋部53而言,病变斑块和血栓是不同的,血栓属于软组织,仅靠螺旋部53就能穿过血栓并吸出体外,对于一些病变较严重的区域来说,在没有使用冲击波401压裂之前,螺旋部53可能无法穿过硬质病变斑块,在病变较严重的血管200中,极其容易引发严重的并发症,如夹层、血管200穿孔和无血流/慢血流等,因此必须配合上述声波发射单元40产生的冲击波401将其压裂后,才能实现其功能(螺旋部53缓慢的转动且往复移动以搅动并带出压裂的病变斑块),且无并发症风险。It should be noted that, for the spiral portion 53, the diseased plaque and the thrombus are different. The thrombus belongs to soft tissue, and the spiral portion 53 alone can pass through the thrombus and be sucked out of the body. For some areas with more serious lesions, the spiral portion 53 may not be able to pass through the hard diseased plaque before the shock wave 401 is used for fracturing. In the blood vessels 200 with more serious lesions, it is very easy to cause serious complications, such as dissection, perforation of the blood vessel 200, and no blood flow/slow blood flow, etc. Therefore, it must be fractured with the shock wave 401 generated by the above-mentioned acoustic wave emitting unit 40 to realize its function (the spiral portion 53 rotates slowly and moves back and forth to stir and bring out the fractured diseased plaque) without the risk of complications.
本申请实施例提供的冲击波球囊导管100,由于第一导管10的内通道13连通有抽吸单元,球囊20与第一导管10之间设置有注液腔21,注液腔21内的声波发射单元40用于在注液腔21内生成冲击波401,且设置在移动丝50前端52的螺旋部53可经第二内管口15移动至内通道13的外部空间,所以在处理闭塞性病变时,可以先将第一导管10和球囊20送至病变部位,然后通过声波发射单元40向外输出非聚焦的冲击波401,产生压缩应力,压裂完全闭塞的病变部位的病变斑块,在完成冲击波401治疗后,再将螺旋部53移动至病变部位,并启动抽吸单元的抽吸功能,螺旋部53在绕随移动丝50一起旋转的同时,还可以沿第一导管10的轴向往复移动,从而不仅可以更好地裂解病变斑块,而且还可以将已经裂解的病变斑块带入内通道13并通过抽吸单元导出体外,避免术中急性血栓的形成,最后再用球囊20对病变部位进行扩张即可完成治疗过程。本申请实施例提供的冲击波球囊导管100,能够将病变部位完全打通,且能回收处理病变结构,避免术中并发症的产生。In the shock wave balloon catheter 100 provided in the embodiment of the present application, since the inner channel 13 of the first catheter 10 is connected with the suction unit, an injection cavity 21 is provided between the balloon 20 and the first catheter 10, and the sound wave emission unit 40 in the injection cavity 21 is used to generate shock waves 401 in the injection cavity 21, and the spiral portion 53 provided at the front end 52 of the moving wire 50 can be moved to the outer space of the inner channel 13 through the second inner tube opening 15, so when treating occlusive lesions, the first catheter 10 and the balloon 20 can be first delivered to the lesion site, and then the non-focused shock waves are output outwardly through the sound wave emission unit 40. 401, generating compressive stress, fracturing the lesion plaque of the completely occluded lesion site, after completing the shock wave 401 treatment, the spiral part 53 is moved to the lesion site, and the suction function of the suction unit is started. While the spiral part 53 rotates around the moving wire 50, it can also reciprocate along the axial direction of the first catheter 10, so that not only the lesion plaque can be better lysed, but also the lysed lesion plaque can be brought into the inner channel 13 and guided out of the body through the suction unit, avoiding the formation of acute thrombus during the operation, and finally the balloon 20 is used to expand the lesion site to complete the treatment process. The shock wave balloon catheter 100 provided in the embodiment of the present application can completely open the lesion site, and can recycle and process the lesion structure to avoid the occurrence of complications during the operation.
本申请实施例提供的冲击波球囊导管100,可以使得冲击波球囊导管100在病变较严重的血管200中获得较好的开通效果,且能回收处理病变斑块,避免术中急性血栓的形成,整个操作过程简单,不对患者有额外损伤。The shock wave balloon catheter 100 provided in the embodiment of the present application can achieve a better opening effect in the blood vessel 200 with more serious lesions, and can recover and process the lesion plaque to avoid the formation of acute thrombosis during the operation. The whole operation process is simple and does not cause additional damage to the patient.
可选地,导线42没有绝缘层43的部分与电极头41采用但不限于激光焊接的方式连接,导线42材料可以为铜,绝缘层43材料可以为聚酰亚胺,电极头41材料可以为不锈钢。由于铜比不锈钢更易损耗,所以如此设置可以在电极头41放电产生冲击波401过程中减少电极头41的损耗,从而增加电极头41的使用寿命。Optionally, the portion of the wire 42 without the insulating layer 43 is connected to the electrode head 41 by, but not limited to, laser welding. The wire 42 may be made of copper, the insulating layer 43 may be made of polyimide, and the electrode head 41 may be made of stainless steel. Since copper is more easily worn than stainless steel, such a configuration can reduce the wear of the electrode head 41 during the process of the electrode head 41 discharging to generate the shock wave 401, thereby increasing the service life of the electrode head 41.
请参考图1和图5,在其中一些实施例中,移动丝50设置有导引部54,导引部54位于螺旋部53背离末端51的一侧。Please refer to FIG. 1 and FIG. 5 . In some embodiments, the moving wire 50 is provided with a guide portion 54 . The guide portion 54 is located on a side of the spiral portion 53 away from the end 51 .
通过采用上述方案,可以在使用螺旋部53搅动已经压裂的病变斑块之前,先将导引部54插入已经压裂的病变斑块内,再转动螺旋部53,从而可以搅动到更多的已经压裂的病变斑块,并可以更好地将已经裂解的病变斑块带入内通道13。By adopting the above scheme, before using the spiral portion 53 to stir the already fractured diseased plaque, the guide portion 54 can be first inserted into the already fractured diseased plaque, and then the spiral portion 53 can be rotated, so that more already fractured diseased plaques can be stirred and the already lysed diseased plaques can be better brought into the inner channel 13.
可选地,导引部54远离螺旋部53的一端设置为尖端541。如此设置,可以更方便地将导引部54插入已经压裂的病变斑块内。Optionally, one end of the guide portion 54 away from the spiral portion 53 is configured as a tip 541. With such a configuration, the guide portion 54 can be more conveniently inserted into the lesion plaque that has been fractured.
其中,尖端541背离螺旋部53的一面设置为圆弧面。如此设置,可以避免尖端541损伤血管200。The surface of the tip 541 away from the spiral portion 53 is configured as an arc surface. This configuration can prevent the tip 541 from damaging the blood vessel 200.
请继续参考图1和图5,在其中一些实施例中,移动丝50还设置有连接部55,螺旋部53位于导引部54和连接部55之间,连接部55与螺旋部53相连接。Please continue to refer to FIG. 1 and FIG. 5 . In some embodiments, the moving wire 50 is further provided with a connecting portion 55 . The spiral portion 53 is located between the guiding portion 54 and the connecting portion 55 . The connecting portion 55 is connected to the spiral portion 53 .
通过采用上述方案,可以提高螺旋部53与移动丝50的连接面积,从而提高二者的连接强度。By adopting the above solution, the connection area between the spiral portion 53 and the moving wire 50 can be increased, thereby improving the connection strength between the two.
请参考图5,在其中一些实施例中,螺旋部53绕设于前端52;或者,螺旋部53的一端与前端52相连接。Please refer to FIG. 5 . In some embodiments, the spiral portion 53 is wound around the front end 52 ; or, one end of the spiral portion 53 is connected to the front end 52 .
通过采用上述方案,可以使得螺旋部53的结构较为简单,且方便加工和与移动丝50组装。By adopting the above solution, the structure of the spiral portion 53 can be made simpler, and it is convenient to process and assemble with the moving wire 50 .
本实施例中,螺旋部53绕设于前端52。如此设置,可使得螺旋部53与移动丝50连接更加紧密。In this embodiment, the spiral portion 53 is wound around the front end 52. This arrangement can make the spiral portion 53 and the moving wire 50 more tightly connected.
请一并参考图6,可选地,螺旋部53沿垂直于螺旋部53轴线方向的横截面为矩形,且矩形的边角设置为倒角。如此设置,既可以避免螺旋部53对血管200内壁造成较大的损伤,也可以确保螺旋部53更好地穿过已经压裂的病变斑块,且保证螺旋部53与碎裂的斑块具有足够大的接触面积,以更好地将已经裂解的病变斑块带入内通道13。Please refer to FIG. 6 , optionally, the cross section of the spiral portion 53 along the direction perpendicular to the axis of the spiral portion 53 is rectangular, and the corners of the rectangle are chamfered. Such a configuration can not only prevent the spiral portion 53 from causing significant damage to the inner wall of the blood vessel 200, but also ensure that the spiral portion 53 can better pass through the already fractured diseased plaque, and ensure that the spiral portion 53 has a sufficiently large contact area with the fragmented plaque, so as to better bring the already lysed diseased plaque into the inner channel 13.
可选地,倒角设置为倒斜角或者倒圆角。本实施例中,倒角设置为倒圆角,以更好地避免螺旋部53对血管200内壁的损伤。Optionally, the chamfer is set as a bevel or a rounded corner. In this embodiment, the chamfer is set as a rounded corner to better prevent the spiral portion 53 from damaging the inner wall of the blood vessel 200.
请参考图图1和5,在其中一些实施例中,为了保证螺旋部53带动压裂的病变斑块的效果,同时避免碎裂的病变斑块在螺旋部53处聚集,螺旋部53的螺距为0.80mm-1.50mm,如0.80mm、1.00mm、1.20mm、1.35mm或1.50mm等。Please refer to Figures 1 and 5. In some of the embodiments, in order to ensure the effect of the spiral portion 53 in driving the fractured diseased plaques and at the same time avoid the accumulation of broken diseased plaques at the spiral portion 53, the pitch of the spiral portion 53 is 0.80mm-1.50mm, such as 0.80mm, 1.00mm, 1.20mm, 1.35mm or 1.50mm.
其中,为了避免螺旋部53的加工难度较高,同时保证螺旋部53带动压裂的病变斑块的效果,螺旋部53的圈数大于或等于2且小于或等于5,如2、3、4或5等。In order to avoid high processing difficulty of the spiral portion 53 and ensure the effect of the spiral portion 53 in driving the fracturing of the diseased plaque, the number of turns of the spiral portion 53 is greater than or equal to 2 and less than or equal to 5, such as 2, 3, 4 or 5.
可选地,球囊20的名义直径为1.05mm-1.50mm,如1.05mm、1.15mm、1.20mm、1.40mm或1.50mm等。如此设置,既可以保证球囊20在血管200内的通过性较佳,能够到达远端曲折、复杂和细小的病变血管200处,也能保证声波发射单元40和螺旋部53具有足够大的尺寸,确保声波发射单元40所释放的冲击波401的能量能够压裂闭塞的病变部位的病变斑块,且使得螺旋部53较易加工。Optionally, the nominal diameter of the balloon 20 is 1.05 mm-1.50 mm, such as 1.05 mm, 1.15 mm, 1.20 mm, 1.40 mm or 1.50 mm, etc. Such a configuration can ensure that the balloon 20 has better permeability in the blood vessel 200 and can reach the distal tortuous, complex and small diseased blood vessels 200, and can also ensure that the sound wave emitting unit 40 and the spiral portion 53 have a sufficiently large size, ensuring that the energy of the shock wave 401 released by the sound wave emitting unit 40 can fracture the diseased plaque of the occluded diseased part, and making the spiral portion 53 easier to process.
在本实施例中,球囊20的名义长度为12mm,名义直径为1.5mm,用于冠状动脉慢性完全闭塞,螺旋部53的圈数为3,螺距为1.0mm,螺旋部53沿垂直于螺旋部53轴线方向的横截面为带倒角的矩形。In this embodiment, the nominal length of the balloon 20 is 12 mm, the nominal diameter is 1.5 mm, and it is used for chronic total occlusion of the coronary artery. The number of turns of the spiral portion 53 is 3, the pitch is 1.0 mm, and the cross-section of the spiral portion 53 along the direction perpendicular to the axis of the spiral portion 53 is a chamfered rectangle.
请参考图8,在另一实施例中,球囊20的名义长度为12mm,名义直径为1.5mm,用于冠状动脉慢性完全闭塞,螺旋部53的圈数为4,螺距为1.2mm,螺旋部53沿垂直于螺旋部53轴线方向的横截面为带倒角的矩形。Please refer to Figure 8. In another embodiment, the nominal length of the balloon 20 is 12 mm, the nominal diameter is 1.5 mm, it is used for chronic total occlusion of the coronary artery, the number of turns of the spiral portion 53 is 4, the pitch is 1.2 mm, and the cross-section of the spiral portion 53 along the direction perpendicular to the axis of the spiral portion 53 is a chamfered rectangle.
请参考图1、图2和图3,在其中一些实施例中,冲击波球囊导管100还包括固定套设在第二端12的显影环60,显影环60位于注液腔21内。Please refer to FIG. 1 , FIG. 2 and FIG. 3 . In some of the embodiments, the shock wave balloon catheter 100 further includes a developing ring 60 fixedly sleeved on the second end 12 . The developing ring 60 is located in the injection cavity 21 .
通过采用上述方案,可以使用显影环60更好地观察病变部位的情况。By adopting the above solution, the developing ring 60 can be used to better observe the condition of the lesion site.
请参考图1、图2和图5,在其中一些实施例中,冲击波球囊导管100还包括与末端51相连的移动单元(图中未示出),移动单元用于带动移动丝50围绕螺旋部53的轴线转动,且移动单元用于带动移动丝50沿第一导管10的轴向往复移动。Please refer to Figures 1, 2 and 5. In some embodiments, the shock wave balloon catheter 100 also includes a moving unit (not shown in the figures) connected to the end 51, and the moving unit is used to drive the moving wire 50 to rotate around the axis of the spiral portion 53, and the moving unit is used to drive the moving wire 50 to reciprocate along the axial direction of the first catheter 10.
通过采用上述方案,可以使用移动单元自动带动移动丝50围绕螺旋部53的轴线转动,且同时用移动单元自动带动移动丝50沿第一导管10的轴向往复移动,操作简单,使用方便。By adopting the above solution, the moving unit can be used to automatically drive the moving wire 50 to rotate around the axis of the spiral portion 53, and at the same time, the moving unit can automatically drive the moving wire 50 to reciprocate along the axial direction of the first catheter 10, which is simple to operate and easy to use.
可选地,移动单元包括旋转动力件和伸缩动力件;旋转动力件与末端51相连接,旋转动力件用于带动移动丝50围绕螺旋部53的轴线转动,旋转动力件可以采用电机等;伸缩动力件具有伸缩端,伸缩端与旋转动力件相连接,伸缩动力件用于带动旋转动力件和移动丝50共同沿第一导管10的轴向往复移动,伸缩动力件可以采用气缸等。Optionally, the moving unit includes a rotating power member and a telescopic power member; the rotating power member is connected to the end 51, and is used to drive the moving wire 50 to rotate around the axis of the spiral portion 53. The rotating power member can be a motor or the like; the telescopic power member has a telescopic end, and the telescopic end is connected to the rotating power member. The telescopic power member is used to drive the rotating power member and the moving wire 50 to move back and forth along the axial direction of the first catheter 10. The telescopic power member can be a cylinder or the like.
可以理解的是,声波发射单元40的电源、抽吸单元和移动单元可以集成于一个主机中。It is understandable that the power supply, suction unit and moving unit of the acoustic wave emitting unit 40 can be integrated into one host.
以上实施例仅用以说明本申请的技术方案,而非对其限制;尽管参照前述实施例对本申请进行了详细的说明,本领域的普通技术人员应当理解:其依然可以对前述各实施例所记载的技术方案进行修改,或者对其中部分技术特征进行等同替换;而这些修改或者替换,并不使相应技术方案的本质脱离本申请各实施例技术方案的精神和范围,均应包含在本申请的保护范围之内。The above embodiments are only used to illustrate the technical solutions of the present application, rather than to limit them. Although the present application has been described in detail with reference to the aforementioned embodiments, those skilled in the art should understand that they can still modify the technical solutions described in the aforementioned embodiments, or make equivalent replacements for some of the technical features therein. These modifications or replacements do not deviate the essence of the corresponding technical solutions from the spirit and scope of the technical solutions of the embodiments of the present application, and should all be included in the protection scope of the present application.
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| EP4649988A3 (en) * | 2020-05-08 | 2026-01-07 | Daniel Ezra Walzman | Torus balloon with energy emitters for intravascular lithotripsy |
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Inventor after: Hu Jun Inventor after: Song Jingzhong Inventor after: Cao Hanwen Inventor after: Liu Bin Inventor before: Hu Jun Inventor before: Cao Hanwen Inventor before: Liu Bin Inventor before: Song Jingzhong |