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CN206120922U - Pipe with annular sacculus - Google Patents

Pipe with annular sacculus Download PDF

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Publication number
CN206120922U
CN206120922U CN201620799707.8U CN201620799707U CN206120922U CN 206120922 U CN206120922 U CN 206120922U CN 201620799707 U CN201620799707 U CN 201620799707U CN 206120922 U CN206120922 U CN 206120922U
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China
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catheter
conduit
support
balloon
filling
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冯睿
景在平
冯家烜
李振江
周建
刘军军
张荣杰
侯钦茂
赵玉玺
秦锋
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Second Military Medical University SMMU
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Second Military Medical University SMMU
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Abstract

本实用新型涉及医疗器械技术领域,具体是一种具有环形球囊的导管,包括导管本体和充盈导管,所述的充盈导管连通充盈通道,该充盈通道设置沿所述导管本体的轴向设置;所述充盈通道连通支撑导管,该支撑导管沿所述导管本体的周向均布,所述支撑导管上设有侧孔,支撑导管的两端连接在导管本体上、支撑导管中部与导管本体保持距离;所述支撑导管上设有球囊,所述球囊相互连接后形成环形结构,且环绕在所述导管本体的外周。本实用新型的有益效果是,可对血管,特别是主动脉内进行周向均匀地扩张,且同时能够维持持续血流通畅,减少因为对血管内一特定区域充盈扩张时所受到的血流冲击力,更加利于球囊扩张位置的固定。

The utility model relates to the technical field of medical devices, in particular to a catheter with a ring-shaped balloon, including a catheter body and a filling catheter. The filling catheter communicates with a filling channel, and the filling channel is arranged along the axial direction of the catheter body; The filling channel communicates with a support conduit, the support conduit is evenly distributed along the circumference of the conduit body, the support conduit is provided with a side hole, the two ends of the support conduit are connected to the conduit body, and the middle part of the support conduit maintains a distance from the conduit body; The support catheter is provided with balloons, and the balloons are connected to each other to form a ring structure and surround the outer periphery of the catheter body. The beneficial effect of the utility model is that the blood vessels, especially the aorta, can be evenly expanded in the circumferential direction, and at the same time, the continuous blood flow can be maintained, and the blood flow impact due to the filling and expansion of a specific area in the blood vessels can be reduced. force, which is more conducive to the fixation of the balloon expansion position.

Description

一种具有环形球囊的导管A catheter with an annular balloon

技术领域technical field

本实用新型涉及医疗器械技术领域,具体是一种具有环形球囊的导管。The utility model relates to the technical field of medical instruments, in particular to a catheter with an annular balloon.

背景技术Background technique

随着人民生活水平的提高和人口结构老龄化,血管系统疾病的发生率和致残、致死率逐年上升。以主动脉夹层为例,其传统外科治疗是开胸和/或开腹,用人工血管置换病变主动脉,常需要体外循环,创伤大、失血多,并发症率和死亡率都很高。With the improvement of people's living standards and the aging population structure, the incidence of vascular system diseases and the disability and mortality rates are increasing year by year. Taking aortic dissection as an example, the traditional surgical treatment is thoracotomy and/or laparotomy, and replacement of the diseased aorta with artificial blood vessels often requires extracorporeal circulation, which involves large trauma, blood loss, and high complication rate and mortality.

目前已开展了主动脉扩张性疾病腔内隔绝术,即采用微创方法,通过血管腔内置入腔内移植物来封闭夹层破口或隔绝主动脉瘤,从而达到治疗目的。所说的血管腔内隔绝移植物由管形金属丝支架和缝合或粘合于支架内侧的人造血管组成,管形金属丝支架由弹性金属丝经Z形折叠后围成直管形而成,人造血管由人造血管膜材料制成,人造血管膜材料通常为涤纶(聚对苯二甲酸乙二醇酯,英文名polyethyleneterephthalate简称PET)。使用时将血管腔内隔绝移植物压缩后装载于输送器中,由输送器通过远处股动脉或髂动脉送到主动脉瘤处再将其释放,由于金属丝支架的弹力作用自动恢复成直管状并紧贴于主动脉内壁,将病变部位与血流隔离,从而达到了治疗目的。这一方法无需开放性手术,简捷微创、疗效确切,成功救治了大批病员。由于患者病变血管解剖形态不规则,常常有扭曲、成角、狭窄、钙化等复杂形变,支架释放后难以自行展开至最佳形态,常不能与动脉管壁完全帖附,还有可能出现支架展开不完全、折叠、扭曲的现象,可导致内漏、远端血流灌注不足等并发症。此时,球囊导管对支架进行扩张塑形成为必要的步骤,可使腔内移植物在血管腔内保持良好形态,提高腔内隔绝术的治疗效果。At present, endovascular exclusion of aortic dilatational disease has been carried out, that is, a minimally invasive method is used to seal the dissection breach or isolate the aortic aneurysm by inserting an endovascular graft into the blood vessel cavity, so as to achieve the purpose of treatment. The said vascular endoluminal isolation graft is composed of a tubular wire stent and an artificial blood vessel sutured or bonded inside the stent, and the tubular wire stent is formed of a straight tube surrounded by an elastic metal wire folded in a Z shape. The artificial blood vessel is made of artificial blood vessel membrane material, and the artificial blood vessel membrane material is usually polyester (polyethylene terephthalate, English name polyethyleneterephthalate, referred to as PET). When in use, the intravascular isolation graft is compressed and loaded into the delivery device. The delivery device sends it to the aortic aneurysm through the distant femoral artery or iliac artery and then releases it. Due to the elastic force of the wire stent, it automatically returns to a straight line Tubular and close to the inner wall of the aorta, the lesion is isolated from the blood flow, thus achieving the purpose of treatment. This method does not require open surgery, is simple and minimally invasive, has definite curative effects, and has successfully treated a large number of patients. Due to the irregular anatomical shape of the patient's diseased blood vessels, there are often complex deformations such as distortion, angulation, stenosis, and calcification. After the stent is released, it is difficult to expand to the best shape by itself, and often cannot be completely attached to the arterial wall, and stent deployment may also occur. Incomplete, folded, and distorted phenomena can lead to complications such as endoleak and distal blood perfusion insufficiency. At this time, the expansion and shaping of the stent by the balloon catheter becomes a necessary step, which can keep the endoluminal graft in good shape in the vessel cavity and improve the therapeutic effect of endoluminal exclusion.

然而,目前现有用于主动脉腔内移植物释放后扩张塑形的球囊主要为单叶顺应性球囊,在对支架扩张塑形的同时将完全阻塞血管,导致远端血流中断,完全阻断也导致血流搏动性冲击力直接作用于球囊,导致球囊移位。现有的另一种三叶顺应性球囊,扩张后与动脉管壁接触面较小,需三次以上重复扩张,同时球囊扩张后虽可有血流从球囊间缝隙通过,但可通过流量有限,仍对远端血流灌注产生影响,承受较大的血流冲击力,尤其在升主动脉和胸主动脉中使用。因而需要开发一种新的球囊来解决此问题。一种中空直管形球囊不仅可对移植物进行快速均匀塑形,还可维持远端持续的血流,也降低搏动性血流冲击力带来的操作难度和风险。However, the existing balloons used to expand and shape the aortic endoluminal graft after release are mainly single-leaf compliant balloons, which will completely block the blood vessel while expanding and shaping the stent, resulting in interruption of distal blood flow. The occlusion also causes the pulsatile impact force of the blood flow to act directly on the balloon, causing the balloon to dislodge. Another existing three-lobe compliant balloon has a small contact surface with the arterial wall after expansion, requiring more than three repeated expansions. At the same time, blood flow can pass through the gap between the balloons after the balloon is expanded, but it can pass through the gap between the balloons. The flow rate is limited, and it still affects the distal blood perfusion and bears a large blood flow impact, especially in the ascending aorta and thoracic aorta. Therefore, it is necessary to develop a new balloon to solve this problem. A hollow straight tubular balloon can not only quickly and uniformly shape the graft, but also maintain the continuous blood flow at the distal end, and reduce the difficulty and risk of operation caused by the impact of pulsating blood flow.

实用新型内容Utility model content

本实用新型的目的在于克服现有技术的不足,提供一种在对血管腔内进行扩张塑形的同时维持持续血流的血管导管。The purpose of the utility model is to overcome the deficiencies of the prior art and provide a vascular catheter that maintains continuous blood flow while expanding and shaping the vascular lumen.

为了达到上述目的,本实用新型提供了一种具有环形球囊的导管,包括导管本体和充盈导管,所述的充盈导管连通充盈通道,该充盈通道设置沿所述导管本体的轴向设置;In order to achieve the above purpose, the utility model provides a catheter with an annular balloon, including a catheter body and a filling catheter, the filling catheter communicates with a filling channel, and the filling channel is arranged along the axial direction of the catheter body;

所述充盈通道连通支撑导管,该支撑导管沿所述导管本体的周向均布,所述支撑导管上设有侧孔,支撑导管的两端连接在导管本体上、支撑导管中部与导管本体保持距离;The filling channel communicates with a support conduit, the support conduit is evenly distributed along the circumference of the conduit body, the support conduit is provided with side holes, the two ends of the support conduit are connected to the conduit body, and the middle part of the support conduit maintains a distance from the conduit body;

所述支撑导管上设有球囊,所述球囊相互连接后形成环形结构,且环绕在所述导管本体的外周,每个球囊分别通过侧孔与相应的支撑导管连通,所述球囊与导管本体保持距离。所述球囊通过热压或光固化材料粘结的方式与具有一定硬度的支撑导管进行连接。所述导管主体的长度为100-140cm,外径为8-12F,内径为0.035inch。操作时,血管导管内可穿过导丝,当导管本体沿导丝推送至目标部位后,可以从充盈导管充入气体或液体,充入的气体或液体依次经过充盈通道、支撑导管后注入球囊内,达到扩张塑形的目的,同时,由于支撑导管、球囊分别和导管本体之间保持距离,形成供血流持续流动的空间,因此在扩张塑形的过程中,并不阻断血流。所述的球囊的材质为尼龙类聚合物、生物医用可降解聚合物、天然纤维材料或其混合物。所述球囊的外表面涂有亲水涂层,所述亲水涂层可以是带有羧酸基、磺酸基、硫酸基、氨基、季氨基和醚基官能团中的一种或多种。若干个球囊组成多叶球囊的结构,所述多叶球囊的定义为:将一环形囊腔通过隔膜进行分隔,形成“多叶”的形状。所述支撑导管与球囊通过侧孔相通,球囊整体形成的直管形结构与导管本体共轴平行。操作时,血管导管内可穿过导丝,当导管本体沿导丝推送至目标部位后,可以从充盈导管充入气体或液体,充入的气体或液体依次经过充盈通道、支撑导管后注入球囊内,使多个球囊同时均匀地张开。所述的球囊充气后的长度为20-60mm,内径为10-30mm,厚度为3-6mm。The support catheter is provided with balloons, and the balloons are connected to each other to form a ring structure and surround the periphery of the catheter body. Each balloon communicates with the corresponding support catheter through a side hole. The balloon Keep away from the catheter body. The balloon is connected with the support catheter with a certain hardness by thermal pressing or light-curing material bonding. The length of the catheter main body is 100-140cm, the outer diameter is 8-12F, and the inner diameter is 0.035inch. During operation, the guide wire can pass through the vascular catheter. After the catheter body is pushed to the target site along the guide wire, gas or liquid can be filled from the inflation catheter. In the capsule, the purpose of expansion and shaping is achieved. At the same time, since the distance between the support catheter and the balloon and the catheter body is maintained, a space for continuous blood flow is formed. Therefore, the blood flow is not blocked during the expansion and shaping process. flow. The material of the balloon is nylon polymer, biomedical degradable polymer, natural fiber material or a mixture thereof. The outer surface of the balloon is coated with a hydrophilic coating, and the hydrophilic coating may have one or more of carboxylic acid groups, sulfonic acid groups, sulfuric acid groups, amino groups, quaternary amino groups and ether functional groups . Several balloons form a multi-leaf balloon structure, and the definition of the multi-leaf balloon is that an annular cavity is separated by a septum to form a "multi-leaf" shape. The support catheter communicates with the balloon through the side hole, and the straight tubular structure formed as a whole by the balloon is coaxial and parallel to the catheter body. During operation, the guide wire can pass through the vascular catheter. After the catheter body is pushed to the target site along the guide wire, gas or liquid can be filled from the inflation catheter. In the capsule, multiple balloons are expanded evenly at the same time. The length of the balloon after inflation is 20-60mm, the inner diameter is 10-30mm, and the thickness is 3-6mm.

优选地,所述的充盈通道设置在所述导管本体的壁内。所述支撑导管自导管本体发出,与导管本体内的充盈通道连接。Preferably, said inflation channel is provided in the wall of said catheter body. The support catheter is issued from the catheter body and connected with the filling channel in the catheter body.

优选地,所述的导管本体上靠近支撑导管处设有显影标记点;Preferably, a developing marking point is provided on the catheter body close to the supporting catheter;

所述支撑导管与球囊的衔接处也设有显影标记点。所述显影标记点可在推送血管导管的过程中显示球囊的具体位置,以利于球囊的准确定位。The connection between the support catheter and the balloon is also provided with developing marking points. The developing marking point can display the specific position of the balloon during the process of pushing the vascular catheter, so as to facilitate the accurate positioning of the balloon.

优选地,所述的支撑导管的个数为3-6个,每个支撑导管上的侧孔的个数为1-3个。Preferably, the number of the support conduits is 3-6, and the number of side holes on each support conduit is 1-3.

所述的支撑导管的长度为30-70mm。所述的支撑导管充气后的外径为2.5-3.5F。The length of the support conduit is 30-70mm. The outer diameter of the support conduit after being inflated is 2.5-3.5F.

本实用新型的有益效果是,可对血管,特别是主动脉内进行周向均匀地扩张,且同时能够维持持续血流通畅,减少因为对血管内一特定区域充盈扩张时所受到的血流冲击力,更加利于球囊扩张位置的固定。相比现有的三叶球囊,血流通过流量更大,受血流冲击影响更小,扩张后接触面更大而无需多次扩张。The beneficial effect of the utility model is that the blood vessels, especially the aorta, can be evenly expanded in the circumferential direction, and at the same time, the continuous blood flow can be maintained, and the blood flow impact due to the filling and expansion of a specific area in the blood vessels can be reduced. force, which is more conducive to the fixation of the balloon expansion position. Compared with the existing three-leaf balloon, the blood flow is larger, less affected by the impact of blood flow, and the contact surface is larger after expansion without multiple expansions.

附图说明Description of drawings

图1为本实用新型的剖视图;Fig. 1 is a sectional view of the utility model;

图2为本实用新型的右视图;Fig. 2 is the right view of the utility model;

图3为本实用新型的结构示意图。Fig. 3 is a structural schematic diagram of the utility model.

其中:in:

1-本体 2-充盈导管 3-充盈通道1-Body 2-Inflation catheter 3-Inflation channel

4-支撑导管 41-侧孔 5-球囊4-support catheter 41-side hole 5-balloon

6-显影标记点6-Development markers

具体实施方式detailed description

以下结合附图和具体实施例,对本实用新型做进一步说明。Below in conjunction with accompanying drawing and specific embodiment, the utility model is described further.

实施例1:Example 1:

一种具有环形球囊的导管,包括导管本体1和充盈导管2,所述的充盈导管2连通充盈通道3,该充盈通道3设置沿所述导管本体1的轴向设置;A catheter with an annular balloon, comprising a catheter body 1 and an inflation catheter 2, the inflation catheter 2 communicates with an inflation channel 3, and the inflation channel 3 is arranged along the axial direction of the catheter body 1;

所述充盈通道3连通支撑导管4,该支撑导管4沿所述导管本体1的周向均布,所述支撑导管4上设有侧孔41,支撑导管4的两端连接在导管本体1上、支撑导管4中部与导管本体1保持距离;The filling channel 3 communicates with the support conduit 4, which is evenly distributed along the circumference of the conduit body 1, and the support conduit 4 is provided with side holes 41, and the two ends of the support conduit 4 are connected to the conduit body 1, supporting The middle part of the conduit 4 keeps a distance from the conduit body 1;

所述支撑导管4上设有球囊5,所述球囊5相互连接后形成环形结构,且环绕在所述导管本体1的外周,每个球囊5通过侧孔41与支撑导管4连通,所述球囊5与导管本体1保持距离。The support catheter 4 is provided with balloons 5, the balloons 5 are connected to each other to form a ring structure, and surround the outer periphery of the catheter body 1, each balloon 5 communicates with the support catheter 4 through a side hole 41, The balloon 5 is kept at a distance from the catheter body 1 .

所述的充盈通道3设置在所述导管本体1的壁内。The filling channel 3 is arranged in the wall of the catheter body 1 .

所述的导管本体1上靠近支撑导管4处设有显影标记点6;The catheter body 1 is provided with a developing marking point 6 near the supporting catheter 4;

所述支撑导管4与球囊5的衔接处也设有显影标记点6。A developing marking point 6 is also provided at the joint between the support catheter 4 and the balloon 5 .

所述的支撑导管4的个数为3-6个,每个支撑导管4上的侧孔41的个数为1-3个。The number of the support conduits 4 is 3-6, and the number of side holes 41 on each support conduit 4 is 1-3.

所述的支撑导管的长度为30-70mm。The length of the support conduit is 30-70mm.

使用时,根据目标主动脉的部位和相应的动脉内径,选择合适规格型号的血管导管,在球囊尚未充盈时,将导管本体经由导丝从股动脉或髂动脉进入主动脉管腔内,在显影标记点的准确定位后,推送至目标部位,通过向充盈导管内注入一定压力的气体或液体(可以是混合造影剂的生理盐水),使球囊充盈膨胀、均匀膨胀,来实现对主动脉进行周向扩张塑形的目的。When in use, according to the location of the target aorta and the corresponding inner diameter of the artery, select a vascular catheter of appropriate specifications. After the accurate positioning of the developing marker point, push it to the target site, and inject a certain pressure of gas or liquid (can be physiological saline mixed with contrast agent) into the filling catheter to make the balloon inflate and inflate evenly, so as to realize the aortic For the purpose of circumferential expansion and shaping.

以上已对本实用新型创造的较佳实施例进行了具体说明,但本实用新型创造并不限于所述的实施例,熟悉本领域的技术人员在不违背本实用新型创造精神的前提下还可以作出种种的等同的变型或替换,这些等同变型或替换均包含在本申请权利要求所限定的范围内。The preferred embodiments of the utility model creation have been specifically described above, but the utility model creation is not limited to the described embodiments, and those skilled in the art can also make Various equivalent modifications or replacements are all included within the scope defined by the claims of the present application.

Claims (5)

1.一种具有环形球囊的导管,包括导管本体(1)和充盈导管(2),其特征在于,所述的充盈导管(2)连通充盈通道(3),该充盈通道(3)设置沿所述导管本体(1)的轴向设置;1. A catheter with an annular balloon, comprising a catheter body (1) and a filling catheter (2), characterized in that the filling catheter (2) communicates with a filling channel (3), and the filling channel (3) is set arranged along the axial direction of the catheter body (1); 所述充盈通道(3)连通支撑导管(4),该支撑导管(4)沿所述导管本体(1)的周向均布,所述支撑导管(4)上设有侧孔(41),支撑导管(4)的两端连接在导管本体(1)上、支撑导管(4)中部与导管本体(1)保持距离;The filling channel (3) communicates with the support conduit (4), and the support conduit (4) is uniformly distributed along the circumference of the conduit body (1), and the support conduit (4) is provided with a side hole (41), and the support conduit (4) The two ends of (4) are connected to the conduit body (1), and the middle part of the support conduit (4) maintains a distance from the conduit body (1); 所述支撑导管(4)上设有球囊(5),所述球囊(5)相互连接后形成环形结构,且环绕在所述导管本体(1)的外周,每个球囊(5)分别通过侧孔(41)与相应的支撑导管(4)连通,所述球囊(5)与导管本体(1)保持距离。The support catheter (4) is provided with balloons (5), and the balloons (5) are connected to each other to form a ring structure, and surround the outer periphery of the catheter body (1), each balloon (5) They are respectively communicated with corresponding support catheters (4) through side holes (41), and the balloon (5) is kept at a distance from the catheter body (1). 2.根据权利要求1所述的具有环形球囊的导管,其特征在于,所述的充盈通道(3)设置在所述导管本体(1)的壁内。2. The catheter with annular balloon according to claim 1, characterized in that, the filling channel (3) is arranged in the wall of the catheter body (1). 3.根据权利要求1所述的具有环形球囊的导管,其特征在于,所述的导管本体(1)上靠近支撑导管(4)处设有显影标记点(6);3. The catheter with an annular balloon according to claim 1, characterized in that, the catheter body (1) is provided with a developing marking point (6) near the supporting catheter (4); 所述支撑导管(4)与球囊(5)的衔接处也设有显影标记点(6)。A developing marking point (6) is also provided at the junction of the support catheter (4) and the balloon (5). 4.根据权利要求1所述的具有环形球囊的导管,其特征在于,所述的支撑导管(4)的个数为3-6个,每个支撑导管(4)上的侧孔(41)的个数为1-3个。4. The catheter with annular balloon according to claim 1, characterized in that, the number of said supporting catheters (4) is 3-6, and the side hole (41) on each supporting catheter (4) ) is 1-3. 5.根据权利要求1所述的具有环形球囊的导管,其特征在于,所述的支撑导管(4)的长度为30-70mm。5. The catheter with annular balloon according to claim 1, characterized in that, the length of the supporting catheter (4) is 30-70 mm.
CN201620799707.8U 2016-07-27 2016-07-27 Pipe with annular sacculus Expired - Fee Related CN206120922U (en)

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN108904943A (en) * 2018-04-20 2018-11-30 厦门仁人医疗科技有限公司 A kind of trachea cannula with ultra-thin sacculus
CN117571522A (en) * 2024-01-16 2024-02-20 首都医科大学附属北京友谊医院 A vascular stent in vitro loading test device
CN120168829A (en) * 2025-04-02 2025-06-20 上海心玮医疗科技股份有限公司 A balloon dilatation catheter

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN108904943A (en) * 2018-04-20 2018-11-30 厦门仁人医疗科技有限公司 A kind of trachea cannula with ultra-thin sacculus
CN117571522A (en) * 2024-01-16 2024-02-20 首都医科大学附属北京友谊医院 A vascular stent in vitro loading test device
CN117571522B (en) * 2024-01-16 2024-05-14 首都医科大学附属北京友谊医院 Vascular stent external loading testing device
CN120168829A (en) * 2025-04-02 2025-06-20 上海心玮医疗科技股份有限公司 A balloon dilatation catheter

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