WO2023006071A1 - Interventional catheter instrument - Google Patents

Abstract

The present invention relates to an interventional catheter instrument. By means of a flexible sheath, not only can damage to tissue passed when the interventional catheter instrument is inserted into a body be prevented, but an interventional catheter can also be kept at an interventional target site, thereby achieving a safe, precise, efficient and easy-to-operate interventional operation.

Description

Translated fromChinese

介入导管器械Interventional Catheter Devices技术领域technical field

本发明涉及医疗器械技术领域，具体而言，涉及一种介入导管器械。The invention relates to the technical field of medical devices, in particular to an interventional catheter device.

背景技术Background technique

以下对本发明的相关背景技术进行说明，但这些说明并不一定构成本发明的现有技术。The background art related to the present invention will be described below, but these descriptions do not necessarily constitute the prior art of the present invention.

介入放射学(Interventional Radiology)是二十世纪七十年代后期迅速发展起来的一门边缘性学科。它是在医学影像设备的引导下，以影像诊断学和临床诊断学为基础，结合临床治疗学原理，利用导管、导丝等器材对各种疾病进行诊断及治疗的一系列技术。即：在影像医学(X线、超声、CT、MRI)的引导下，通过经皮穿刺途径或通过人体原有孔道，将特制的导管或器械插至病变部位进行诊断性造影和治疗的学科，或组织采集，进行细胞学细菌学及生化检查。Interventional Radiology is a marginal subject that developed rapidly in the late 1970s. Under the guidance of medical imaging equipment, it is based on imaging diagnostics and clinical diagnostics, combined with the principles of clinical therapeutics, and uses catheters, guide wires and other equipment to diagnose and treat various diseases. That is: under the guidance of imaging medicine (X-ray, ultrasound, CT, MRI), through the percutaneous puncture or through the original orifice of the human body, a special catheter or instrument is inserted into the lesion for diagnostic imaging and treatment. Or tissue collection, cytology, bacteriology and biochemical examination.

介入放射学为现代医学诊疗提供了新的给药途径和手术方法。与传统的给药途径和手术方法相比较，具有更直接有效、更简便微创。介入放射学开拓了新的治疗途径，且简便、安全、创伤小、合并症少、见效快，具有微创性；可重复性强；定位准确；疗效高、见效快；并发症发生率低；多种技术的联系应用简便易行。Interventional radiology provides new drug delivery routes and surgical methods for modern medical diagnosis and treatment. Compared with traditional routes of drug administration and surgical methods, it is more direct, effective, simpler and minimally invasive. Interventional radiology has opened up a new way of treatment, and it is simple, safe, less traumatic, less complications, quick effect, minimally invasive; strong repeatability; accurate positioning; high curative effect, quick effect; low incidence of complications; The connection and application of multiple technologies is simple and easy.

介入放射学按目的可分为介入诊断学和介入治疗学；按技术可分为：血管性介入放射学(药物灌注；栓塞技术；成形支架；滤器技术等)和非血管放射介入学(穿刺活检；引流技术；异物取除；腔道支架等)；按临床应用范围可分为肿瘤介入放射学、非肿瘤介入放射学、神经介入放射学等等。According to the purpose, interventional radiology can be divided into interventional diagnostics and interventional therapy; according to technology, it can be divided into: vascular interventional radiology (drug infusion; embolization technology; formed stent; filter technology, etc.) and non-vascular interventional radiology (puncture biopsy ; drainage technology; foreign body removal; cavity stent, etc.); according to the scope of clinical application, it can be divided into tumor interventional radiology, non-tumor interventional radiology, neurological interventional radiology, etc.

介入器械是用于实施执行介入诊疗的装置，例如，血管支架套件、经皮穿刺活检套件、射频消融套件、肿瘤栓塞套件等。介入器械一般可包括但不限于 下述任一项或其组合：穿刺类器械、射频类器械、微波类器械、粒子类器械、植入类器械、鞘类器械、管类器械、活检类器械等。介入器械可包括一个或多个介入工具，介入工具可以是导管、导丝、穿刺针、血管鞘、球囊、活检针等等。Interventional devices are devices used to implement interventional diagnosis and treatment, such as vascular stent kits, percutaneous biopsy kits, radiofrequency ablation kits, tumor embolization kits, etc. Interventional devices generally include but are not limited to any of the following or their combination: puncture devices, radio frequency devices, microwave devices, particle devices, implant devices, sheath devices, tube devices, biopsy devices, etc. . An interventional device may include one or more interventional tools, which may be catheters, guide wires, puncture needles, vascular sheaths, balloons, biopsy needles, and the like.

介入放射学中广泛应用了导管技术。以往的导管器械多用于建立介入手术器械的通道，绝大部分不具备特定位置弯曲导向功能(李彦豪.实用临床介入诊疗学图解[M].北京:科学出版社,2012.)。Catheter technology is widely used in interventional radiology. In the past, catheter devices were mostly used to establish channels for interventional surgical devices, and most of them did not have the function of bending and guiding at specific positions (Li Yanhao. Practical Clinical Interventional Diagnosis Diagnosis [M]. Beijing: Science Press, 2012.).

目前，临床上用于人体血管内与器官内的导管器械，有些需要在进入人体后于特定的位置弯曲一定的角度，并在弯曲后对穿刺针、导丝等介入手术器械进行导向引导。如美国COOK生产的RUPS-100穿刺组件的塑料导管器械、金属导管器械，其具有特定位置弯曲导向结构，以实现相应的导向功能。At present, some of the catheter devices clinically used in human blood vessels and organs need to be bent at a certain angle at a specific position after entering the human body, and guide puncture needles, guide wires and other interventional surgical devices after bending. For example, the RUPS-100 puncture assembly plastic catheter device and metal catheter device produced by COOK in the United States have a specific position bending guide structure to realize the corresponding guiding function.

在介入过程中，有时为了实现对于介入的导向，需要导管器械的远端抵靠在介入靶点处，使得介入器械穿过导管器械、伸出导管器械的远端，而准确地在介入靶点进行介入。During the intervention process, sometimes in order to achieve guidance for the intervention, it is necessary for the distal end of the catheter device to abut against the intervention target, so that the intervention device passes through the catheter device, extends out of the distal end of the catheter device, and is accurately positioned at the intervention target. Intervene.

为了防止导管器械的远端在经过介入途径到达介入靶点的过程中对于所经过的组织造成伤害，导管的外部可设有柔性套，该柔性套延伸超过导管的远端，使得导管的远端被柔性套所包覆，以防止其伤害周围的组织。In order to prevent the distal end of the catheter instrument from causing damage to the tissue it passes through the interventional approach to the intervention target, a flexible sleeve can be provided on the outside of the catheter, and the flexible sleeve extends beyond the distal end of the catheter so that the distal end of the catheter Covered by a flexible sleeve to prevent it from injuring surrounding tissue.

在介入手术中，特别是介入途径长且曲折的介入手术，需要介入器械通过导管器械在血管内弯曲一定的角度再进行血管或组织介入。当套设在导管外的柔性套的远端抵靠在介入靶点处时，由于柔性套的柔性，介入过程中无法使其保持在介入靶点处，往往导致介入过程中发生跳针穿不上的失误或介入方向发生变动等误差，给手术操作者造成非常大的操作的难度，目前只能依靠手术从业术者通过体外的导管扶持或人体特定部位按压，大大增加术者操作难度，限制了手术应用。In interventional surgery, especially the interventional surgery with long and tortuous access, it is necessary for the interventional device to bend a certain angle in the blood vessel through the catheter device before performing blood vessel or tissue intervention. When the distal end of the flexible sheath placed outside the catheter abuts against the intervention target, due to the flexibility of the flexible sheath, it cannot be kept at the intervention target during the intervention process, often resulting in skipped needle insertion during the intervention. Mistakes on the surface or changes in the direction of intervention have caused great difficulty for the operator. At present, the operator can only rely on the support of the catheter outside the body or pressing on a specific part of the human body, which greatly increases the difficulty of the operation for the operator. Limitations surgical application.

例如，经颈静脉肝内穿刺手术中，使导管器械能在肝静脉壁上保持在穿刺靶点处就是此手术穿刺成功的关键(李彦豪.实用临床介入诊疗学图解[M].北 京:科学出版社,2012.)。而目前的穿刺组件无法有效解决该问题(褚建国,我国经颈静脉肝内门体分流技术的发展现状及其规范化,中华介入放射学电子杂志,2013,1(2))。For example, in transjugular vein intrahepatic puncture, keeping the catheter device on the hepatic vein wall at the puncture target is the key to successful puncture (Li Yanhao. Practical Clinical Interventional Diagnosis Diagnosis [M]. Beijing: Science Publishing Society, 2012.). However, the current puncture components cannot effectively solve this problem (Chu Jianguo, The development status and standardization of transjugular intrahepatic portosystemic shunt technology in China, Chinese Electronic Journal of Interventional Radiology, 2013, 1(2)).

因而，亟需一种既能防止伤害所经的周围组织、又能在介入过程中保持在介入靶点处的导管器械，以防止在介入过程中发生跳针穿刺不上的失误或介入方向发生变动的误差。Therefore, there is an urgent need for a catheter device that can prevent damage to the surrounding tissues and can also be kept at the intervention target point during the intervention, so as to prevent the occurrence of missed needle puncture or the occurrence of intervention direction during the intervention. variable error.

发明内容Contents of the invention

有鉴于此，本发明实施例提供一种介入导管器械，以解决上述现有介入手术中易于伤害所经的周围组织、难于保持在介入靶点处、操作难度大、准确性差等问题中的一个或多个，实现更易操作、更准确有效的介入手术。In view of this, an embodiment of the present invention provides an interventional catheter device to solve one of the problems in the above-mentioned existing interventional surgery, which are easy to damage the surrounding tissue, difficult to maintain at the interventional target, difficult to operate, and poor in accuracy. or more, to achieve easier operation, more accurate and effective interventional surgery.

根据本发明的一个方面，本发明提供了一种介入导管器械，其特征在于，包括：导向管；柔性套，所述柔性套套设于所述导向管外；所述柔性套与所述导向管能够相对移动，使得所述柔性套的远端延伸超出所述导向管的远端、或者所述导向管的远端延伸超出所述柔性套的远端。According to one aspect of the present invention, the present invention provides an interventional catheter device, which is characterized in that it includes: a guide tube; a flexible sleeve, the flexible sleeve is set outside the guide tube; the flexible sleeve and the guide tube Relatively movable such that the distal end of the flexible sheath extends beyond the distal end of the guide tube, or the distal end of the guide tube extends beyond the distal end of the flexible sheath.

进一步，所述柔性套的远端设有缩口部分，所述缩口部分的内径小于所述导向管的外径，并且所述缩口部分设有易于破损的弱化部分，当所述介入导管器械抵靠到介入靶点时，使所述导向管相对所述柔性套向远端移动能够破坏所述弱化部分，从而所述导向管延伸超出所述柔性套的远端。Further, the distal end of the flexible sleeve is provided with a constricted part, the inner diameter of the constricted part is smaller than the outer diameter of the guide tube, and the constricted part is provided with a weakened part that is easy to break, when the intervention catheter Moving the guide tube distally relative to the flexible sheath breaks the weakened portion when the instrument is positioned against the interventional target, such that the guide tube extends beyond the distal end of the flexible sheath.

进一步，所述弱化部分延伸至所述柔性套的远端开口。Further, the weakened portion extends to the distal opening of the flexible sheath.

进一步，所述弱化部分沿所述柔性套的纵向、以直线方式或螺旋方式延伸至所述柔性套的远端开口。Further, the weakened portion extends to the distal opening of the flexible sheath in a linear or helical manner along the longitudinal direction of the flexible sheath.

进一步，所述弱化部分是断续的刻线或压痕。Further, the weakened portion is intermittent scoring lines or indentations.

进一步，所述弱化部分设置于所述弱化部分的内表面或外表面。Further, the weakened portion is disposed on the inner surface or the outer surface of the weakened portion.

进一步，所述缩口部分的内径比所述导向管的外径小0.05mm～1mm。Further, the inner diameter of the constricted part is 0.05mm-1mm smaller than the outer diameter of the guide tube.

进一步，所述柔性套的材料包括但不限于聚四氟乙烯、氟化乙烯丙烯共聚 物、热塑性聚氨酯弹性体、尼龙12、嵌段聚醚酰胺弹性体、高密度聚乙烯中的一种或多种。Further, the material of the flexible sleeve includes but not limited to one or more of polytetrafluoroethylene, fluorinated ethylene propylene copolymer, thermoplastic polyurethane elastomer,nylon 12, block polyetheramide elastomer, high-density polyethylene kind.

进一步，所述导向管的材料包括但不限于不锈钢、镍钛合金中的一种或多种。Further, the material of the guide tube includes but not limited to one or more of stainless steel and nickel-titanium alloy.

进一步，所述导向管的粗度规格包括但不限于：13G、14G、15G、16G，所述导向管的长度为42cm～57cm。Further, the thickness specification of the guide tube includes but not limited to: 13G, 14G, 15G, 16G, and the length of the guide tube is 42cm-57cm.

进一步，所述柔性套的内径比所述导向管的外径大0.1mm～2mm。Further, the inner diameter of the flexible sleeve is 0.1 mm to 2 mm larger than the outer diameter of the guide tube.

进一步，所述介入导管器械包括连接件，所述导向管的近端通过所述连接件与所述柔性套的近端连接，并且通过所述连接件能够使所述导向管和所述柔性套相对移动。Further, the interventional catheter device includes a connecting piece through which the proximal end of the guide tube is connected to the proximal end of the flexible sheath, and the guiding tube and the flexible sheath can be connected through the connecting piece relatively mobile.

进一步，所述连接件的连接方式为螺纹方式、卡扣方式或粘接方式。Further, the connection method of the connector is a threaded method, a buckle method or an adhesive method.

根据本发明的一个方面，本发明提供了一种介入器械，所述介入器械包括上面所述的介入导管器械。According to one aspect of the present invention, the present invention provides an interventional device, which includes the above-mentioned interventional catheter device.

综上，根据本发明的介入导管器械，既能防止伤害所经的周围组织、又能在介入过程中保持在介入靶点处的导管器械，以防止在介入过程中发生跳针穿刺不上的失误或介入方向发生变动的误差，更加易于操作，更加准确有效，从而解决了现有技术中存在的技术问题。To sum up, the interventional catheter device according to the present invention can not only prevent damage to the surrounding tissue it passes through, but also keep the catheter device at the intervention target point during the intervention process, so as to prevent the occurrence of missed needle puncture during the intervention process. Errors caused by mistakes or changes in the direction of intervention are easier to operate, more accurate and effective, thereby solving the technical problems existing in the prior art.

附图说明Description of drawings

通过以下参照附图提供的具体实施方式部分，本发明的特征和优点将变得更加容易理解，在附图中：The features and advantages of the present invention will become more comprehensible through the following detailed description provided with reference to the accompanying drawings, in which:

图1是本发明实施例的介入导管器械与穿刺针的装配示意图；Fig. 1 is a schematic diagram of the assembly of an interventional catheter device and a puncture needle according to an embodiment of the present invention;

图2是本发明实施例的导向管的示意图；Fig. 2 is the schematic diagram of the guiding tube of the embodiment of the present invention;

图3是本发明实施例的柔性套的示意图；3 is a schematic diagram of a flexible sleeve according to an embodiment of the present invention;

图4是本发明实施例的导向管和柔性套的装配示意图；Fig. 4 is a schematic diagram of assembly of a guide tube and a flexible sleeve according to an embodiment of the present invention;

图5是本发明实施例的导向管和柔性套在经过介入途径到达介入靶点过程 中的状态示意图；Fig. 5 is a schematic diagram of the state of the guide tube and the flexible sleeve of the embodiment of the present invention in the process of reaching the intervention target through the intervention approach;

图6是本发明实施例的导向管和柔性套实施穿刺引导时的状态示意图；Fig. 6 is a schematic diagram of the state of the guide tube and the flexible sleeve when performing puncture guidance according to the embodiment of the present invention;

图7是本发明实施例的导向管和柔性套在实施穿刺引导之后经过介入途径退出过程中的状态示意图；Fig. 7 is a schematic diagram of the state of the guide tube and the flexible sleeve in the embodiment of the present invention during the withdrawal process through the interventional approach after the implementation of puncture guidance;

图8是本发明实施例的远端缩口成型的柔性套的示意图；Fig. 8 is a schematic diagram of a flexible sleeve formed with a distal constriction according to an embodiment of the present invention;

图9是本发明实施例的柔性套的缩口部分的示意图；Fig. 9 is a schematic diagram of the shrinkage part of the flexible sleeve according to the embodiment of the present invention;

图10是本发明实施例的导向管和柔性套在经过介入途径到达介入靶点过程中的状态示意图；Fig. 10 is a schematic diagram of the state of the guide tube and the flexible sleeve in the process of reaching the intervention target through the intervention approach according to the embodiment of the present invention;

图11是本发明实施例的导向管和柔性套实施穿刺引导时的状态示意图；Fig. 11 is a schematic diagram of the state of the guide tube and the flexible sleeve when performing puncture guidance according to the embodiment of the present invention;

图12是本发明实施例的导向管和柔性套在实施穿刺引导之后经过介入途径退出过程中的状态示意图。Fig. 12 is a schematic view of the state of the guide tube and the flexible sleeve in the embodiment of the present invention during the withdrawal process through the interventional approach after the implementation of puncture guidance.

具体实施方式Detailed ways

下面参照附图对本发明的示例性实施方式进行详细描述。对示例性实施方式的描述仅仅是出于示范目的，而绝不是对本发明及其应用或用法的限制。Exemplary embodiments of the present invention will be described in detail below with reference to the accompanying drawings. The description of the exemplary embodiments is for the purpose of illustration only, and in no way limits the invention and its application or usage.

为使本发明的目的、优点和特征更加清楚，以下结合附图对本发明作进一步详细说明。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。In order to make the purpose, advantages and features of the present invention clearer, the present invention will be further described in detail below in conjunction with the accompanying drawings. It should be noted that all the drawings are in a very simplified form and use imprecise scales, and are only used to facilitate and clearly assist the purpose of illustrating the embodiments of the present invention.

如在本发明中所使用的，单数形式“一”、“一个”以及“该”包括复数对象，除非内容另外明确指出外。如在本发明中所使用的，术语“或”通常是以包括“和/或”的含义而进行使用的，除非内容另外明确指出外。在本发明中所述的“远端”、“远侧”是指远离操作者的一侧；相应的，“近端”、“近侧”是与“远端”、“远侧”相对的一侧。As used herein, the singular forms "a", "an" and "the" include plural referents unless the content clearly dictates otherwise. As used herein, the term "or" is generally employed in its sense including "and/or" unless the content clearly dictates otherwise. The "far end" and "far side" mentioned in the present invention refer to the side away from the operator; correspondingly, "proximal end" and "near side" are opposite to "far end" and "far side" side.

图1是本发明实施例的介入导管器械和穿刺针的装配示意图。本发明实施例中，如图1所示，导管器械1可包括导向管11和柔性套12，以为穿刺针2提供导向引导。根据临床需求，导管器械1可以是直线状的，也可以是弯曲状 的，例如弯曲状的可用于经颈静脉肝内穿刺手术。Fig. 1 is a schematic diagram of the assembly of an interventional catheter device and a puncture needle according to an embodiment of the present invention. In the embodiment of the present invention, as shown in FIG. 1 , thecatheter device 1 may include aguide tube 11 and aflexible sheath 12 to provide guidance for the puncture needle 2 . According to clinical needs, thecatheter device 1 can be straight or curved, for example, the curved one can be used for intrahepatic puncture through the jugular vein.

图2是本发明实施例的导向管的示意图。本发明实施例中，导向管11的材料可以是包括但不限于不锈钢、镍钛合金等中一种或多种。根据临床需要，导向管11的粗度规格可以包括但不限于：13G、14G、15G、16G等(G为GAUGE的缩写，是起源于北美的一种关于直径的长度计量单位)；长度规格可以为42cm～57cm。Fig. 2 is a schematic diagram of a guide tube according to an embodiment of the present invention. In the embodiment of the present invention, the material of theguide tube 11 may be one or more materials including but not limited to stainless steel, nickel-titanium alloy and the like. According to clinical needs, the thickness specifications of theguide tube 11 can include but are not limited to: 13G, 14G, 15G, 16G, etc. It is 42cm～57cm.

如图2所示，导向管11的远端可为斜刃型，可用于进行穿刺，也可用于刺入介入靶点从而抵靠住介入靶点。As shown in FIG. 2 , the distal end of theguide tube 11 can be bevelled, which can be used for puncturing, or for piercing into the intervention target so as to abut against the intervention target.

如图2所示，根据临床需要，导向管11的远侧可形成一处或多处弯曲。本发明一实施例中，导向管11的远端为弯曲的斜刃型，距离斜刃尖端0.5cm～12cm处可弯曲10°～80°，例如弯曲60°。As shown in FIG. 2 , according to clinical needs, one or more bends can be formed on the distal side of theguide tube 11 . In one embodiment of the present invention, the distal end of theguide tube 11 is a curved oblique blade, which can be bent by 10° to 80°, for example, 60°, at a distance of 0.5 cm to 12 cm from the tip of the oblique blade.

图3是本发明实施例的柔性套的示意图。本发明实施例中，柔性套12的材料可以包括但不限于聚四氟乙烯(PTFE)、氟化乙烯丙烯共聚物(FEP)、热塑性聚氨酯弹性体(TPU)、尼龙12(PA12)、嵌段聚醚酰胺弹性体(Pebax)、高密度聚乙烯(HDPE)等中的一种或多种。Fig. 3 is a schematic diagram of a flexible sleeve according to an embodiment of the present invention. In the embodiment of the present invention, the material of theflexible sleeve 12 may include but not limited to polytetrafluoroethylene (PTFE), fluorinated ethylene propylene copolymer (FEP), thermoplastic polyurethane elastomer (TPU), nylon 12 (PA12), block One or more of polyetheramide elastomer (Pebax), high-density polyethylene (HDPE), etc.

图4是本发明实施例的导向管和柔性套的装配示意图。本发明实施例中，如图4所示，柔性套12可套设于导向管11外，其内径可比导向管11的外径大0.1mm～2mm。导向管11和柔性套12可相对移动，从而使得，导向管11的远端可延伸超出柔性套12的远端，或者柔性套12的远端可延伸超出导向管11的远端(如图4所示)。Fig. 4 is a schematic diagram of the assembly of the guide tube and the flexible sleeve according to the embodiment of the present invention. In the embodiment of the present invention, as shown in FIG. 4 , theflexible sleeve 12 can be sleeved on the outside of theguide tube 11 , and its inner diameter can be 0.1 mm to 2 mm larger than the outer diameter of theguide tube 11 . Theguide tube 11 and theflexible sheath 12 can move relative to each other, so that the distal end of theguide tube 11 can extend beyond the distal end of theflexible sheath 12, or the distal end of theflexible sheath 12 can extend beyond the distal end of the guide tube 11 (as shown in Figure 4 shown).

本发明实施例中，柔性套12的近端可通过连接件13与导向管11的近端以螺纹、卡扣或粘接方式连接，并且可通过连接件13使柔性套12与导向管12相对移动。如图1或图4示出了柔性套12和导向管11的近端通过连接件13以螺纹方式连接。In the embodiment of the present invention, the proximal end of theflexible sheath 12 can be connected with the proximal end of theguide tube 11 through the connectingpiece 13 in a threaded, buckled or adhesive manner, and theflexible sheath 12 can be opposite to the guidingtube 12 through the connectingpiece 13 move. As shown in FIG. 1 or FIG. 4 , theflexible sheath 12 and the proximal end of theguide tube 11 are threadedly connected through the connectingpiece 13 .

本发明实施例的穿刺手术中，包括导向管11和柔性套12的导管器械1先经皮或经器官腔道等介入途径进入体内到达穿刺靶点。图5是本发明实施例的 导向管和柔性套在经过介入途径到达介入靶点过程中的状态示意图。如图5所示，在此过程中，柔性套12套设于导向管管11外，柔性套12的远端延伸超出导向管11的远端斜刃2～3mm，以防止该远端斜刃伤害所经过的组织。In the puncture operation of the embodiment of the present invention, thecatheter device 1 including theguide tube 11 and theflexible sheath 12 first enters the body through the skin or through an organ cavity to reach the puncture target. Fig. 5 is a schematic view of the state of the guide tube and the flexible sleeve of the embodiment of the present invention in the process of reaching the intervention target through the intervention approach. As shown in Figure 5, during this process, theflexible sleeve 12 is sleeved outside theguide tube 11, and the distal end of theflexible sleeve 12 extends beyond the distal beveled edge of theguide tube 11 by 2 to 3 mm to prevent the distal beveled edge from Injury to the tissue it passes through.

本发明实施例的穿刺手术中，当导管器械1的远端到达穿刺靶点后，可让导向管11和柔性套12相对移动，使得导向管11的远端延伸超出柔性套12的远端，从而导向管11的远端可抵靠住穿刺靶点不动，以实施穿刺引导。图6是本发明实施例的导向管和柔性套实施穿刺引导时的状态示意图。In the puncture operation of the embodiment of the present invention, when the distal end of thecatheter instrument 1 reaches the puncture target, theguide tube 11 and theflexible sheath 12 can be moved relatively so that the distal end of theguide tube 11 extends beyond the distal end of theflexible sheath 12, Therefore, the distal end of theguide tube 11 can be fixed against the puncture target to implement puncture guidance. Fig. 6 is a schematic view of the state of the guide tube and the flexible sleeve implementing puncture guidance according to the embodiment of the present invention.

本发明实施例的穿刺手术中，当导管器械1在实施穿刺引导之后要经过介入途径退出时，可让导向管11和柔性套12相对移动，使得柔性套12的远端延伸超出导向管11的远端斜刃，以防止该远端斜刃伤害所经过的组织。图7是本发明实施例的导向管和柔性套在实施穿刺引导之后经过介入途径退出过程中的状态示意图。In the puncture operation of the embodiment of the present invention, when thecatheter instrument 1 is to be withdrawn through the interventional approach after implementing puncture guidance, theguide tube 11 and theflexible sheath 12 can be relatively moved so that the distal end of theflexible sheath 12 extends beyond the end of theguide tube 11 The distal bevel to prevent the distal bevel from injuring the passing tissue. Fig. 7 is a schematic view of the state of the guide tube and the flexible sleeve in the embodiment of the present invention during the withdrawal process through the interventional approach after the implementation of puncture guidance.

在介入诊疗中，导管器械的远端在经过介入途径到达介入靶点的过程中，特别是介入途径长且曲折的介入手术，会受到所经过的组织、器官的阻力作用，由于柔性套的柔性，常会导致柔性套相对于导向管向近端移动，使得导向管的远端延伸超出柔性套的远端，从而伤害到所经过的周围组织。In interventional diagnosis and treatment, when the distal end of the catheter device reaches the intervention target through the interventional route, especially the interventional operation with a long and tortuous interventional route, it will be affected by the resistance of the tissues and organs it passes through. Due to the flexibility of the flexible sleeve , often causes the flexible sheath to move proximally relative to the guide tube, causing the distal end of the guide tube to extend beyond the distal end of the flexible sheath, thereby injuring the passing surrounding tissue.

为解决该技术问题，进一步地，本发明实施例中，柔性套12的远端可进行缩口成型加工，形成缩口部分121，缩口部分121可以为锥形，成型后该缩口部分的内径可比导向管11的外径小0.05mm～1mm。图8是本发明实施例的远端缩口成型的柔性套的示意图。In order to solve this technical problem, further, in the embodiment of the present invention, the distal end of theflexible sleeve 12 can be necked and formed to form anecked part 121, and thenecked part 121 can be tapered. After molding, the necked part The inner diameter may be smaller than the outer diameter of theguide tube 11 by 0.05 mm to 1 mm. Fig. 8 is a schematic diagram of a flexible sleeve formed with a distal constriction according to an embodiment of the present invention.

由于柔性套12的缩口部分成型的远端的内径小于导向管11的远端的外径，在导管器械1经过介入途径到达介入靶点的过程中，柔性套12即使受到所经过的组织、器官的阻力作用，也不会相对于导向管11向近端移动，使得导向管11不会从柔性套12的远端伸出，从而伤害所经过的组织。Since the inner diameter of the distal end of theflexible sheath 12 is smaller than the outer diameter of the distal end of theguide tube 11, theflexible sheath 12 is affected by the passing tissue, Due to the resistance of the organ, theguide tube 11 will not move proximally relative to theguide tube 11, so that theguide tube 11 will not protrude from the distal end of theflexible sheath 12, thereby damaging the passing tissues.

进一步，图9是本发明实施例的柔性套的缩口部分的示意图。本发明实施例中，柔性套12的缩口部分121上可设有易于破损的弱化部分1211，如图9 所示。弱化部分1211可延伸至柔性套12的远端开口。弱化部分1211可以是断续的刻线或压痕，可沿柔性套12的纵向以直线方式或螺旋方式延伸至其远端开口。弱化部分1211可设置于缩口部分121的内表面或外表面。当弱化部分1211设置于缩口部分121的外表面时，可在外表面上形成凹陷，会对血管壁产生刺激，也会对血流产生影响，从而增加形成血栓的可能性。因而，优选地，弱化部分1211设置于缩口部分121的内表面。Further, Fig. 9 is a schematic view of the necking part of the flexible sleeve according to the embodiment of the present invention. In the embodiment of the present invention, a weakenedportion 1211 that is easy to break can be provided on theconstricted portion 121 of theflexible sleeve 12 , as shown in FIG. 9 . The weakenedportion 1211 may extend to the distal opening of theflexible sheath 12 . The weakenedportion 1211 may be an intermittent score line or indentation, and may extend to the opening of the distal end of theflexible sheath 12 in a linear or helical manner along the longitudinal direction of theflexible sheath 12 . The weakenedportion 1211 can be disposed on the inner surface or the outer surface of theconstriction portion 121 . When the weakenedportion 1211 is disposed on the outer surface of theconstricted portion 121 , a depression may be formed on the outer surface, which will stimulate the blood vessel wall and affect the blood flow, thereby increasing the possibility of thrombus formation. Therefore, preferably, the weakenedportion 1211 is disposed on the inner surface of theconstricted portion 121 .

弱化部分1211使得当导管器械1抵靠到介入靶点时，施加大于上述阻力的作用力、相对于柔性套12向远端推进导向管11时，导向管11可破坏弱化部分121而伸出柔性套12的远端开口。本发明一实施例中，弱化部分121为1mm宽的纵向压痕。The weakenedpart 1211 makes it possible for theguide tube 11 to destroy the weakenedpart 121 and stretch out theflexible part 121 when a force greater than the above-mentioned resistance is applied and theguide tube 11 is pushed distally relative to theflexible sheath 12 when thecatheter device 1 abuts against the intervention target point. The distal end of thecover 12 is open. In one embodiment of the present invention, the weakenedportion 121 is a longitudinal indentation with a width of 1 mm.

从而，本发明实施例的穿刺手术中，导向管11和柔性套12先经皮或经器官腔道等介入途径进入体内到达穿刺靶点。图10是本发明实施例的导向管和柔性套在经过介入途径到达介入靶点过程中的状态示意图；如图10所示，在此过程中，柔性套12套设于导向管管11外，柔性套12的缩口部分延伸超出导向管11的远端斜刃2～3mm，以防止该远端斜刃伤害所经过的组织。Therefore, in the puncture operation in the embodiment of the present invention, theguide tube 11 and theflexible sheath 12 first enter the body to reach the puncture target through the skin or the organ cavity. Fig. 10 is a schematic diagram of the state of the guide tube and the flexible sleeve of the embodiment of the present invention in the process of reaching the intervention target through the intervention approach; as shown in Fig. 10, during this process, theflexible sleeve 12 is sleeved outside theguide tube 11, The constricted portion of theflexible sheath 12 extends beyond the distal beveled edge of theguide tube 11 by 2-3 mm to prevent the distal beveled edge from injuring the passing tissue.

本发明实施例的穿刺手术中，当导管器械1的远端到达穿刺靶点后，可施加大于上述阻力的作用力、相对于柔性套12向远端推进导向管11，使得导向管11破坏弱化部分121而伸出柔性套12的远端开口2～3mm，如此，导向管11的远端斜刃可刺入穿刺靶点，使其在穿刺过程中可始终保持在穿刺靶点处，以为穿刺针2提供穿刺引导导向。接着就可将穿刺针2穿过导管器械1对穿刺靶点进行穿刺。图11是本发明实施例的导向管和柔性套实施穿刺引导时的状态示意图。In the puncture operation of the embodiment of the present invention, when the distal end of thecatheter device 1 reaches the puncture target, a force greater than the above-mentioned resistance can be applied to push theguide tube 11 distally relative to theflexible sleeve 12, so that theguide tube 11 is damaged and weakened.Part 121 protrudes from the distal opening of theflexible sheath 12 by 2 to 3 mm, so that the distal inclined edge of theguide tube 11 can penetrate into the puncture target, so that it can always remain at the puncture target during the puncture process, so as to facilitate the puncture. Needle 2 provides the puncture guide. Then the puncture needle 2 can be passed through thecatheter device 1 to puncture the puncture target. Fig. 11 is a schematic diagram of the state of the guide tube and the flexible sleeve implementing puncture guidance according to the embodiment of the present invention.

本发明实施例中，当穿刺针2的穿刺完成后，可相对于柔性套12向近端拉回导向管11，使导向管11的远端斜刃缩进柔性套12的远端开口之内3～5mm。之后，沿原介入途径取出导向管11和柔性套12。由于导向管11的远端斜刃已缩进柔性套12的远端开口之内，不会对所经的组织形成伤害。并且在导管器 械1退出过程中，柔性套12所受的阻力作用的方向是向远端方向，不会导致柔性套12相对于导向管11向近端移动，也就不会使导向管11的远端延伸出柔性套12的远端而对所经的组织造成伤害。图12是本发明实施例的导向管和柔性套在实施穿刺引导之后经过介入途径退出过程中的状态示意图。In the embodiment of the present invention, after the puncture of the puncture needle 2 is completed, theguide tube 11 can be pulled back proximally relative to theflexible sheath 12, so that the distal inclined edge of theguide tube 11 can retract into the distal opening of theflexible sheath 12 3~5mm. Afterwards, theguide tube 11 and theflexible sheath 12 are taken out along the original intervention route. Since the distal inclined edge of theguide tube 11 has retracted into the distal opening of theflexible sheath 12, no damage will be caused to the passing tissue. And in the process of withdrawing thecatheter instrument 1, the direction of the resistance effect of theflexible sleeve 12 is in the direction of the distal end, which will not cause theflexible sleeve 12 to move proximally relative to theguide tube 11, and will not cause theguide tube 11 to move toward the proximal end. The distal end extends beyond the distal end of theflexible sheath 12 to injure tissue passed through. Fig. 12 is a schematic view of the state of the guide tube and the flexible sleeve in the embodiment of the present invention during the withdrawal process through the interventional approach after the implementation of puncture guidance.

介入器械是用于实施执行介入诊疗的装置，例如，血管支架套件、经皮穿刺活检套件、射频消融套件、肿瘤栓塞套件等。介入器械一般可包括但不限于下述任一项或其组合：穿刺类器械、射频类器械、微波类器械、粒子类器械、植入类器械、鞘类器械、管类器械、活检类器械等。介入器械可包括一个或多个介入工具，介入工具可以是导管、导丝、穿刺针、血管鞘、球囊、活检针等等。Interventional devices are devices used to implement interventional diagnosis and treatment, such as vascular stent kits, percutaneous biopsy kits, radiofrequency ablation kits, tumor embolization kits, etc. Interventional devices generally include but are not limited to any of the following or their combination: puncture devices, radio frequency devices, microwave devices, particle devices, implant devices, sheath devices, tube devices, biopsy devices, etc. . An interventional device may include one or more interventional tools, which may be catheters, guide wires, puncture needles, vascular sheaths, balloons, biopsy needles, and the like.

本发明实施例中，可提供一种介入器械，该介入器械可包括上面所述的介入导管器械。In an embodiment of the present invention, an interventional device may be provided, and the interventional device may include the above-mentioned interventional catheter device.

本发明实施例的介入导管器械，既能防止伤害所经的周围组织，又能在介入过程中保持在血管内或组织内的介入靶点处，给术者搭建稳定可靠的导向结构，以引导穿刺或置入介入器械。介入导管器械的结构和工艺简单，成本低廉，操作性好，高效安全，能满足术者对弯曲穿刺时精准导向的要求。The interventional catheter device of the embodiment of the present invention can not only prevent damage to the surrounding tissue it passes through, but also keep it at the intervention target point in the blood vessel or tissue during the intervention process, and build a stable and reliable guiding structure for the operator to guide Puncture or insert interventional devices. The interventional catheter device has a simple structure and process, low cost, good operability, high efficiency and safety, and can meet the operator's requirements for precise guidance during curved puncture.

综上，上述实施例对介入导管器械进行了详细说明，当然，本发明包括但不限于上述实施，任何在上述实施例的基础上进行变换的内容，均属于本发明所保护的范围。本领域技术人员可以根据上述实施例的内容举一反三。To sum up, the above-mentioned embodiment has described the interventional catheter device in detail. Of course, the present invention includes but is not limited to the above-mentioned implementation, and any content that is transformed on the basis of the above-mentioned embodiment falls within the scope of protection of the present invention. Those skilled in the art can draw inferences based on the content of the foregoing embodiments.

上述描述仅是对本发明较佳实施例的描述，并非对本发明范围的任何限定，本发明领域的普通技术人员根据上述揭示内容做的任何变更、修饰，均属于权利要求书的保护范围。The above description is only a description of the preferred embodiments of the present invention, and does not limit the scope of the present invention. Any changes and modifications made by those of ordinary skill in the field of the present invention based on the above disclosures shall fall within the protection scope of the claims.

虽然参照示例性实施方式对本发明进行了描述，但是应当理解，本发明并不局限于文中详细描述和示出的具体实施方式，在不偏离权利要求书所限定的范围的情况下，本领域技术人员可以对所述示例性实施方式做出各种改变，所 有的这种改变均落入本发明的保护范围。Although the present invention has been described with reference to exemplary embodiments, it should be understood that the present invention is not limited to the specific embodiments described and shown in detail herein, and that it is possible for those skilled in the art to do so without departing from the scope defined by the claims. Personnel may make various changes to the exemplary embodiments described, all such changes falling within the scope of the present invention.

尽管已描述了本发明的优选实施例，但本领域内的技术人员一旦得知了基本创造性概念，则可对这些实施例作出另外的变更和修改。所以，所附权利要求意欲解释为包括优选实施例以及落入本发明范围的所有变更和修改。While preferred embodiments of the invention have been described, additional changes and modifications to these embodiments can be made by those skilled in the art once the basic inventive concept is appreciated. Therefore, it is intended that the appended claims be construed to cover the preferred embodiment as well as all changes and modifications which fall within the scope of the invention.

显然，本领域的技术人员可以对本发明进行各种改动和变型而不脱离本发明的精神和范围。这样，倘若本发明的这些修改和变型属于本发明权利要求及其等同技术的范围之内，则本发明也意图包含这些改动和变型在内。Obviously, those skilled in the art can make various changes and modifications to the present invention without departing from the spirit and scope of the present invention. Thus, if these modifications and variations of the present invention fall within the scope of the claims of the present invention and their equivalent technologies, the present invention also intends to include these modifications and variations.

Claims (14)

Translated fromChinese

一种介入导管器械，其特征在于，包括：An interventional catheter device, characterized in that it comprises:导向管；guide tube;柔性套，所述柔性套套设于所述导向管外；a flexible sleeve, the flexible sleeve is sleeved on the outside of the guide tube;所述柔性套与所述导向管能够相对移动，使得所述柔性套的远端延伸超出所述导向管的远端、或者所述导向管的远端延伸超出所述柔性套的远端。The flexible sheath and the guide tube can move relatively, so that the distal end of the flexible sheath extends beyond the distal end of the guide tube, or the distal end of the guide tube extends beyond the distal end of the flexible sheath.根据权利要求1所述的介入导管器械，其特征在于，所述柔性套的远端设有缩口部分，所述缩口部分的内径小于所述导向管的外径，并且所述缩口部分设有易于破损的弱化部分，当所述介入导管器械抵靠到介入靶点时，使所述导向管相对所述柔性套向远端移动能够破坏所述弱化部分，从而所述导向管延伸超出所述柔性套的远端。The interventional catheter device according to claim 1, wherein the distal end of the flexible sheath is provided with a constriction portion, the inner diameter of the constriction portion is smaller than the outer diameter of the guide tube, and the constriction portion having a breakable weakened portion that can be broken by moving the guide tube distally relative to the flexible sheath when the interventional catheter instrument abuts against the interventional target, so that the guide tube extends beyond the distal end of the flexible sheath.根据权利要求2所述的介入导管器械，其特征在于，所述弱化部分延伸至所述柔性套的远端开口。The interventional catheter device of claim 2, wherein the weakened portion extends to the distal opening of the flexible sheath.根据权利要求2-3中任一项所述的介入导管器械，其特征在于，所述弱化部分沿所述柔性套的纵向、以直线方式或螺旋方式延伸至所述柔性套的远端开口。The interventional catheter device according to any one of claims 2-3, characterized in that, the weakened portion extends to the distal opening of the flexible sheath in a linear or helical manner along the longitudinal direction of the flexible sheath.根据权利要求2-4中任一项所述的介入导管器械，其特征在于，所述弱化部分是断续的刻线或压痕。The interventional catheter device according to any one of claims 2-4, characterized in that the weakened portion is an intermittent score line or indentation.根据权利要求2-5中任一项所述的介入导管器械，其特征在于，所述弱化部分设置于所述弱化部分的内表面或外表面。The interventional catheter device according to any one of claims 2-5, characterized in that, the weakened portion is provided on an inner surface or an outer surface of the weakened portion.根据权利要求2-6中任一项所述的介入导管器械，其特征在于，所述缩口部分的内径比所述导向管的外径小0.05mm～1mm。The interventional catheter device according to any one of claims 2-6, characterized in that, the inner diameter of the constricted part is 0.05mm-1mm smaller than the outer diameter of the guide tube.根据权利要求1-7中任一项所述的介入导管器械，其特征在于，所述柔性套的材料包括但不限于聚四氟乙烯、氟化乙烯丙烯共聚物、热塑性聚氨酯弹性体、尼龙12、嵌段聚醚酰胺弹性体、高密度聚乙烯中的一种或多种。The interventional catheter device according to any one of claims 1-7, wherein the material of the flexible sheath includes but not limited to polytetrafluoroethylene, fluorinated ethylene propylene copolymer, thermoplastic polyurethane elastomer, nylon 12 , block polyether amide elastomer, one or more of high-density polyethylene.根据权利要求1-8中任一项所述的介入导管器械，其特征在于，所述导向管的材料包括但不限于不锈钢、镍钛合金中的一种或多种。The interventional catheter device according to any one of claims 1-8, characterized in that, the material of the guide tube includes but not limited to one or more of stainless steel and nickel-titanium alloy.根据权利要求1-9中任一项所述的介入导管器械，其特征在于，所述导向管的粗度规格包括但不限于：13G、14G、15G、16G，所述导向管的长度为42cm～57cm。The interventional catheter device according to any one of claims 1-9, characterized in that, the thickness specification of the guide tube includes but not limited to: 13G, 14G, 15G, 16G, and the length of the guide tube is 42cm ~57cm.根据权利要求1-10中任一项所述的介入导管器械，其特征在于，所述柔性套的内径比所述导向管的外径大0.1mm～2mm。The interventional catheter device according to any one of claims 1-10, characterized in that, the inner diameter of the flexible sleeve is 0.1 mm to 2 mm larger than the outer diameter of the guide tube.根据权利要求1-11中任一项所述的介入导管器械，其特征在于，所述介入导管器械包括连接件，所述导向管的近端通过所述连接件与所述柔性套的近端连接，并且通过所述连接件能够使所述导向管和所述柔性套相对移动。The interventional catheter device according to any one of claims 1-11, characterized in that, the interventional catheter device comprises a connecting piece, and the proximal end of the guide tube is connected to the proximal end of the flexible sleeve through the connecting piece. connected, and the guide tube and the flexible sleeve can move relative to each other through the connecting piece.根据权利要求12所述的介入导管器械，其特征在于，所述连接件的连接方式为螺纹方式、卡扣方式或粘接方式。The interventional catheter device according to claim 12, characterized in that, the connection method of the connecting member is a screw method, a buckle method or an adhesive method.一种介入器械，其特征在于，所述介入器械包括根据权利要求1-13中任一项所述的介入导管器械。An interventional device, characterized in that the interventional device comprises the interventional catheter device according to any one of claims 1-13.

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