CN107050625B - Anti-deep insertion reinforced support guide catheter - Google Patents
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- CN107050625B CN107050625B CN201710035265.9A CN201710035265A CN107050625B CN 107050625 B CN107050625 B CN 107050625B CN 201710035265 A CN201710035265 A CN 201710035265A CN 107050625 B CN107050625 B CN 107050625B
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- 238000003780 insertion Methods 0.000 title claims description 16
- 230000037431 insertion Effects 0.000 title claims description 16
- 239000007788 liquid Substances 0.000 claims abstract description 16
- 239000012530 fluid Substances 0.000 claims description 7
- 230000007704 transition Effects 0.000 claims description 6
- 239000002872 contrast media Substances 0.000 claims description 4
- 239000002504 physiological saline solution Substances 0.000 claims description 3
- 208000029078 coronary artery disease Diseases 0.000 abstract description 3
- 210000004204 blood vessel Anatomy 0.000 description 9
- 210000004351 coronary vessel Anatomy 0.000 description 6
- 210000000709 aorta Anatomy 0.000 description 4
- 238000010586 diagram Methods 0.000 description 3
- 230000003902 lesion Effects 0.000 description 3
- 239000008280 blood Substances 0.000 description 2
- 210000004369 blood Anatomy 0.000 description 2
- 230000017531 blood circulation Effects 0.000 description 2
- 230000002708 enhancing effect Effects 0.000 description 2
- 238000000034 method Methods 0.000 description 2
- 230000035515 penetration Effects 0.000 description 2
- 238000001356 surgical procedure Methods 0.000 description 2
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 1
- 208000024248 Vascular System injury Diseases 0.000 description 1
- 208000012339 Vascular injury Diseases 0.000 description 1
- 230000001154 acute effect Effects 0.000 description 1
- 230000002411 adverse Effects 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 230000000903 blocking effect Effects 0.000 description 1
- 230000001684 chronic effect Effects 0.000 description 1
- 230000004087 circulation Effects 0.000 description 1
- 230000006378 damage Effects 0.000 description 1
- 230000007812 deficiency Effects 0.000 description 1
- 238000002594 fluoroscopy Methods 0.000 description 1
- 238000013152 interventional procedure Methods 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- -1 polyethylene terephthalate Polymers 0.000 description 1
- 229920000139 polyethylene terephthalate Polymers 0.000 description 1
- 239000005020 polyethylene terephthalate Substances 0.000 description 1
- 238000002601 radiography Methods 0.000 description 1
- 231100000216 vascular lesion Toxicity 0.000 description 1
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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
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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
- A61M25/0043—Catheters; Hollow probes characterised by structural features
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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
- A61M2025/1093—Balloon catheters with special features or adapted for special applications having particular tip characteristics
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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
- A61M2210/00—Anatomical parts of the body
- A61M2210/12—Blood circulatory system
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Abstract
Description
技术领域technical field
本发明涉及医疗器械领域,具体涉及一种应用到冠脉介入手术的防深插增强支撑型导引导管。The invention relates to the field of medical devices, in particular to an anti-deep insertion enhanced support guide catheter applied to coronary interventional surgery.
背景技术Background technique
冠心病发病率越来越高,复杂冠脉病变越来越多,此类冠脉介入手术难度大,要完成复杂病变,特别是扭曲血管病变、慢性闭塞病变,需要强有力支撑导导引导管。一个好的指导引导管必须具有良好的主动支撑和被动支撑能力,所谓主动支撑能力指的是导管向冠脉血管前向输送能力,常常因为担心导管深插进冠脉内而不能过度依耐此能力;而所谓被动支撑能力与指导引导管的直径大小、导管与主动脉接触面积、导管与主动脉壁之间摩擦力、导管与主动脉之间夹角大小成正比。目前市上所有导引导管依靠改变导管尖端形状来增加支撑,而每个病人的主动脉根部结构及冠脉开口、大小等均有差异,仍不能避免在进行复杂冠脉介入手术时导引导管尖端向后移位甚至脱离血管开口,为了增加支撑,有时会深插至冠脉内,导致血管损伤引起血管撕裂从而导致急性不良事件,甚至死亡。The incidence of coronary heart disease is getting higher and higher, and there are more and more complex coronary lesions. This type of coronary intervention is difficult. To complete complex lesions, especially twisted vascular lesions and chronic occlusive lesions, a strong supporting guiding catheter is required. . A good guiding guide tube must have good active support and passive support capabilities. The so-called active support capacity refers to the ability of the catheter to transport forward to the coronary blood vessels. Often, it is not possible to rely too much on it because of the fear of deep insertion of the catheter into the coronary artery. The so-called passive support capacity is proportional to the diameter of the guiding catheter, the contact area between the catheter and the aorta, the friction between the catheter and the aortic wall, and the angle between the catheter and the aorta. At present, all guide catheters on the market rely on changing the shape of the catheter tip to increase support, and each patient's aortic root structure, coronary artery opening, size, etc. The tip is displaced backwards or even detached from the opening of the blood vessel. In order to increase support, it is sometimes inserted deep into the coronary artery, causing vascular injury and tearing of the blood vessel, resulting in acute adverse events and even death.
发明内容Contents of the invention
本发明针对现有技术的不足,提出一种结构简单,操作方便,有效增强导引导管的支撑力,避免导引导管深插损伤血管,安全可靠的防深插增强支撑型导引导管,具体技术方案如下:Aiming at the deficiencies of the prior art, the present invention proposes a safe and reliable anti-deep insertion enhanced support type guiding catheter with simple structure, convenient operation, effectively enhancing the supporting force of the guiding catheter, avoiding deep insertion of the guiding catheter to damage blood vessels, and specifically The technical scheme is as follows:
一种防深插增强支撑型导引导管,包括导引导管管体(1),所述导引导管管体(1)尖端部设置有可收缩和充盈的支撑球囊(2),该支撑球囊(2)连接有充液管道(3),该充液管道(3)位于所述导引导管管体(1)的内壁,或者外壁,或者所述导引导管管体(1)的管壁中。An anti-deep insertion enhanced support guide catheter, comprising a guide catheter body (1), the tip of the guide catheter body (1) is provided with a shrinkable and inflatable support balloon (2), the support The balloon (2) is connected with a fluid-filled pipeline (3), and the fluid-filled pipeline (3) is located on the inner wall or the outer wall of the guide catheter body (1), or on the inner wall of the guide catheter body (1). in the pipe wall.
本发明的使用方法为:采用常规造影导丝引导下送入导引导管管体到主动脉根部,送入过程若有阻力,可旋转调整方向前进,在X线透视下调整导引导管尖端到理想位置,以生理盐水或造影剂通过充液管道(3)进入支撑球囊(2)中将其充盈,支撑球囊(2)作为导引导管管体的支撑点,既能有效防止深插,又能阻止导管深插的同时增加导管与主动脉接触面积、增加主动脉与导引导管夹角,从而增强支撑完成复杂冠脉介入手术,结束介入后,退出所有介入器械,将支撑球囊(2)负压抽吸至极限,慢慢退出体外,完成介入手术。The method of use of the present invention is as follows: under the guidance of a conventional radiography guide wire, the tube body of the guiding catheter is sent to the aortic root. In an ideal position, physiological saline or contrast agent enters the support balloon (2) through the fluid-filled pipeline (3) to inflate it, and the support balloon (2) acts as a support point for the guiding catheter body, which can effectively prevent deep insertion , and can prevent the catheter from being inserted deeply while increasing the contact area between the catheter and the aorta, increasing the angle between the aorta and the guiding catheter, thereby enhancing the support to complete complex coronary interventional procedures. (2) Suction to the limit with negative pressure, slowly withdraw from the body, and complete the interventional operation.
为更好的实现本发明,可进一步为:For realizing the present invention better, can further be:
所述支撑球囊(2)位于所述导引导管管体(1)的侧壁上,该支撑球囊(2)充盈后与所述导引导管管体(1)的侧壁采用直角过渡,使其支撑球囊(2)不会跟随导引导管滑入血管中,避免出现血管撕裂,该支撑球囊(2)的顶部采用圆弧过渡,保证导引导管穿入过程中的平顺性。The support balloon (2) is located on the side wall of the guide catheter body (1), and the support balloon (2) adopts a right-angle transition to the side wall of the guide catheter body (1) after being inflated , so that the supporting balloon (2) will not slide into the blood vessel following the guiding catheter, avoiding blood vessel tearing, and the top of the supporting balloon (2) adopts a circular arc transition to ensure smooth penetration of the guiding catheter sex.
所述支撑球囊(2)充盈后的高度D为6-9mm,长度C为10mm。充盈后支撑球囊(2)直径以导引导管直径一半为宜,球囊直径越大支撑越强,但会阻塞血管腔血流;充盈后球囊高度+导管直径应大于冠脉血管直径的一倍,目前冠脉血管开口直径在4-6mm之间,导引导管的直径是0.33mm*5-8之间,因此选择充盈后球囊高度为6-9mm,充盈后球囊长度10mm,长度越长支撑力越强。The height D of the support balloon (2) after filling is 6-9 mm, and the length C is 10 mm. The diameter of the support balloon (2) after inflation should be half the diameter of the guide catheter. The larger the diameter of the balloon, the stronger the support, but it will block the blood flow in the vessel cavity; the height of the balloon + catheter diameter after inflation should be greater than the diameter of the coronary vessel Double, the current diameter of the coronary artery opening is between 4-6mm, and the diameter of the guiding catheter is between 0.33mm*5-8, so the balloon height after filling is 6-9mm, and the length of the balloon after filling is 10mm. The longer the length, the stronger the support.
在所述支撑球囊(2)上沿所述导引导管管体(1)的轴向开设有通孔,该通孔的设置,减小支撑球囊(2)对血液的阻挡。A through hole is opened on the support balloon (2) along the axial direction of the guide catheter tube body (1). The setting of the through hole reduces the blocking of blood by the support balloon (2).
在所述导引导管管体(1)尖端部的侧壁上开有网孔(4),可增加冠脉前向血流。A mesh (4) is opened on the side wall of the tip of the guiding catheter tube body (1), which can increase the blood flow forward in the coronary artery.
所述支撑球囊(2)为圆环形,该支撑球囊(2)的内环外壁与所述导引导管管体(1)的外壁连接,采用圆环形结构,可让支撑点受力更加均匀,同时可减小对心脏冠室的压强,更加安全可靠。The supporting balloon (2) is circular, and the outer wall of the inner ring of the supporting balloon (2) is connected with the outer wall of the guide catheter body (1). The force is more uniform, and at the same time, the pressure on the coronary chamber of the heart can be reduced, which is safer and more reliable.
所述导引导管管体(1)由内管(11)和外管(12)组成,所述内管(11)的外壁和外管(12)的内壁形成的腔体为所述充液管道(3),或者所述充液管道(3)位于所述内管(11)的外壁和外管(12)的内壁形成的腔体中。结构简单,尤其采用内管(11)和外管(12)两层结构,生产工艺简单,一体性能优越。The guiding catheter body (1) is composed of an inner tube (11) and an outer tube (12), and the cavity formed by the outer wall of the inner tube (11) and the inner wall of the outer tube (12) is the liquid-filled The pipe (3), or the liquid-filled pipe (3) is located in a cavity formed by the outer wall of the inner pipe (11) and the inner wall of the outer pipe (12). The structure is simple, especially the two-layer structure of the inner tube (11) and the outer tube (12), the production process is simple, and the integral performance is superior.
所述充液管道(3)粘贴在所述导引导管管体(1)的内壁,或者外壁上。The liquid-filled pipeline (3) is pasted on the inner wall or the outer wall of the guiding catheter body (1).
所述支撑球囊(2)与所述导引导管管体(1)尖端的距离A为0.5-1cm。距离过短会导致导引导管插入困难,过长会失去防止插入过深的目的。The distance A between the support balloon (2) and the tip of the guiding catheter body (1) is 0.5-1 cm. If the distance is too short, it will make it difficult to insert the guiding catheter, and if it is too long, the purpose of preventing too deep insertion will be lost.
所述支撑球囊(2)的填充液为生理盐水或造影剂,便于在X光透视下观察支撑球囊(2)。The filling fluid of the supporting balloon (2) is physiological saline or contrast agent, which is convenient for observing the supporting balloon (2) under X-ray fluoroscopy.
本发明的有益效果为:有效改进了现有导引导管的主动及被动支撑力,可防止插入过深,能更好地完成复杂冠心病介入手术,大大降低手术风险,减少因导导引导管不合适更换各种不同形状的导管、导丝从而增加的医疗费用和手术时间。The beneficial effects of the present invention are: the active and passive support force of the existing guiding catheter is effectively improved, the insertion can be prevented from being too deep, the complex interventional surgery for coronary heart disease can be better completed, the operation risk is greatly reduced, and the risk of the guiding catheter is reduced. It is not suitable to replace catheters and guide wires of various shapes, thereby increasing medical expenses and operation time.
附图说明Description of drawings
图1为本发明的结构示意图;Fig. 1 is a structural representation of the present invention;
图2为本发明的使用状态示意图;Fig. 2 is a schematic diagram of the use state of the present invention;
图3为本发明实施例二的结构示意图;FIG. 3 is a schematic structural diagram of
图4为本发明实施例三的结构示意图。Fig. 4 is a schematic structural diagram of
具体实施方式Detailed ways
下面结合附图对本发明的较佳实施例进行详细阐述,以使本发明的优点和特征能更易于被本领域技术人员理解,从而对本发明的保护范围做出更为清楚明确的界定。The preferred embodiments of the present invention will be described in detail below in conjunction with the accompanying drawings, so that the advantages and features of the present invention can be more easily understood by those skilled in the art, so as to define the protection scope of the present invention more clearly.
实施例一:如图1和图2所示,一种防深插增强支撑型导引导管,包括引导管管体1,该导引导管管体1由内管11和外管12组成,在导引导管管体1的尖端部外管12的侧壁上设置有聚对苯二甲酸乙二醇酯制成的可收缩和充盈的支撑球囊2,该支撑球囊2与导引导管管体1尖端的距离距离A为0.5-1cm,支撑球囊2连接有充液管道3,通过充液管道3为支撑球囊2充液或者加负压,其中充液管道3位于内管11和外管12所形成的腔体中,或者直接利用所形成的腔体作为充液管道3;Embodiment 1: As shown in Fig. 1 and Fig. 2, an anti-deep insertion enhanced support type guiding catheter includes a guiding
支撑球囊2采用生理盐水或造影剂充盈后与导引导管管体1的侧壁采用直角过渡,使其支撑球囊2不会跟随导引导管滑入血管中,避免出现血管撕裂,该支撑球囊2的顶部采用圆弧过渡,保证导引导管穿入过程中的平顺性,具体尺寸为高度D为7mm,长度C为10mm;After the
在支撑球囊2上沿导引导管管体1的轴向开设有通孔,在导引导管管体1尖端部的侧壁上开有网孔4,便于血液的流通。A through hole is opened on the
实施例二:在其它结构和实施例一相同的情况下,作为变形,如图3所示,其中支撑球囊2为圆环形,该支撑球囊2套接在导引导管管体1的外壁上,其中支撑球囊2的内环外壁与导引导管管体1的外壁连接。Embodiment 2: In the case that other structures are the same as
实施例三,在其它结构和实施例一相同的情况下,作为变形,如图4所示,其中充液管道3粘贴在导引导管管体1的内壁,或者外壁上,为提高导引导管管体1的光滑度,可在导引导管管体1的外壁或者内壁上设置与充液管道3结构相适应的凹槽,通过凹槽与充液管道3配合,保证导引导管管体1在血管中的通过性。
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