CN106806964B - Intracavity injection catheter device - Google Patents
Intracavity injection catheter deviceDownload PDFInfo
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- CN106806964B CN106806964BCN201510859718.0ACN201510859718ACN106806964BCN 106806964 BCN106806964 BCN 106806964BCN 201510859718 ACN201510859718 ACN 201510859718ACN 106806964 BCN106806964 BCN 106806964B
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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
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- 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
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
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Abstract
Translated fromChinese
Description
Translated fromChinese技术领域technical field
本发明涉及医疗器械领域，尤其涉及一种腔内注射导管装置。The invention relates to the field of medical instruments, in particular to an intracavity injection catheter device.
背景技术Background technique
以去交感神经为核心理念的肾动脉交感神经消融术是治疗顽固性高血压的一种方法，包括射频消融技术和基于导管的非热效应的消融术。其中，对于射频消融技术，由于消融热的影响，与电极接触的血管壁有可能被灼伤，或发生血管痉挛，或造成血管狭窄等并发症，对于基于导管的非热效应的消融领域，已有注射酒精进入血管壁作为神经毒性介质，达到消融交感神经纤维目的。Sympathetic ablation of the renal artery with sympathetic denervation as the core concept is a method for the treatment of resistant hypertension, including radiofrequency ablation techniques and catheter-based ablation of athermal effects. Among them, for radiofrequency ablation, due to the influence of ablation heat, the blood vessel wall in contact with the electrode may be burned, or vasospasm may occur, or complications such as vascular stenosis may occur. Alcohol enters the vessel wall as a neurotoxic mediator to ablate sympathetic nerve fibers.
现有技术揭示了一种用于血管壁注射和血管周肾去神经支配的导管系统，该导管系统的远端100的截面如图1所示。该导管系统包括注射针121及注射针124，它们分别通过引导管122与引导管125在固定导线(丝)110周围展开，以贴合血管壁；注射针121及注射针124的近端与内管112连接，使得内管112的腔113与注射针的腔流体连通，从而通过腔113注射细胞毒性或神经毒性溶液，经由注射针进入血管壁内。在使用时，当该导管系统在血管内输送时，注射针121(124)收于引导管122(125)之内，引导管122(125)收于护套123之内，护套123定位在锥形区段111的远端，此时可将该导管系统在指引导管/输送鞘(未示出)内推进；在到达目标血管时，将导管系统的远端100推出指引导管，拉回护套(外鞘管)123，引导管122(125)在没有护套123的束缚后，因自扩展打开，直到引导管122(125)的远端126(127)对肾动脉内壁向外按压；随后，将注射针121(124)推出引导管122(125)，注射针121(124)穿过血管内膜进入肾动脉的血管壁内；最后，向血管壁内注射合适体积的消融溶液。The prior art discloses a catheter system for vascular wall injection and perivascular renal denervation, the cross-section of the
然而，上述导管系统中，当注射针在引导管内往远端穿刺时，引导管会被推开而偏离目标血管内皮的位置，这不但会增加注射针偏离目标血管内皮的位置的可能，进而增加穿刺的难度，还可能导致注射针刮伤血管内壁。However, in the above catheter system, when the injection needle is punctured distally in the guide tube, the guide tube will be pushed away and deviate from the position of the target vascular endothelium, which not only increases the possibility that the injection needle deviates from the position of the target vascular endothelium, but also increases The difficulty of puncturing may also cause the injection needle to scratch the inner wall of the blood vessel.
发明内容SUMMARY OF THE INVENTION
基于此，有必要提供一种腔内注射导管装置，其可为注射针提供引导及支撑，避免注射针在穿刺时偏移目标血管内皮位置，以利于可靠地完成注射针穿刺及介质注射。Based on this, it is necessary to provide an intraluminal injection catheter device, which can provide guidance and support for the injection needle, avoid the injection needle from deviating from the target vascular endothelium during puncturing, and facilitate the reliable completion of the injection needle puncture and medium injection.
一种腔内注射导管装置，包括：空心导管主体，及注射机构，包括可径向扩张和径向压缩的支撑组件、端头、拉丝和注射针，所述支撑组件设置在所述导管主体的远端与所述端头之间，所述支撑组件包括多根支撑杆，每根支撑杆的远端均与所述端头相连，每根支撑杆的近端均与所述导管主体的远端相连，所述支撑杆上设有供所述注射针穿出的注射针导向孔，所述拉丝的远端穿出所述导管主体，且所述拉丝与所述端头相连，当向近端拉动所述拉丝，所述拉丝将带动所述端头相对所述导管主体运动而控制所述支撑组件径向扩张直至所述注射针可穿过所述注射针导向孔。An intraluminal injection catheter device, comprising: a hollow catheter body, and an injection mechanism, including a radially expandable and radially compressible support assembly, a tip, a drawing wire and an injection needle, the support assembly is provided on the catheter body. Between the distal end and the end head, the support assembly includes a plurality of support rods, the distal end of each support rod is connected to the end head, and the proximal end of each support rod is connected to the distal end of the catheter body. The support rod is provided with an injection needle guide hole for the injection needle to pass through, the distal end of the drawing wire passes through the catheter body, and the drawing wire is connected to the end head. The end pulls the drawing wire, and the drawing wire will drive the end head to move relative to the catheter body to control the radial expansion of the support assembly until the injection needle can pass through the injection needle guide hole.
在其中一个实施方式中，所述支撑组件还包括至少一根注射针导向管，至少一根所述支撑杆内侧设有一根所述注射针导向管，所述支撑杆上的注射针导向孔较其所在的支撑杆上的注射针导向管靠近所述端头，至少一根所述注射针导向管中收容有一根所述注射针，且每根注射针至少部分位于所述导管主体内。In one of the embodiments, the support assembly further includes at least one injection needle guide tube, at least one injection needle guide tube is provided inside the at least one support rod, and the injection needle guide hole on the support rod is relatively small. The injection needle guide tube on the support rod where it is located is close to the end, at least one of the injection needle guide tubes accommodates one injection needle, and each injection needle is at least partially located in the catheter body.
在其中一个实施方式中，所述端头为实心结构，所述拉丝与所述端头固定连接。In one embodiment, the end head is a solid structure, and the drawing wire is fixedly connected with the end head.
在其中一个实施方式中，所述端头设有轴向通孔，所述拉丝远端穿出所述通孔，且所述拉丝与端头固定连接，所述拉丝穿出端头的部分形成导向段。In one embodiment, the end is provided with an axial through hole, the distal end of the drawing wire passes through the through hole, and the drawing wire is fixedly connected to the end, and the part of the drawing wire passing through the end forms a guide section.
在其中一个实施方式中，所述导向段表面附有保护层。In one of the embodiments, a protective layer is attached to the surface of the guide segment.
在其中一个实施方式中，所述端头设有轴向通孔，所述拉丝远端穿出所述通孔，所述拉丝穿出所述端头的部分上固定设置一限位球，所述限位球的直径大于所述通孔的直径。In one embodiment, the end is provided with an axial through hole, the distal end of the drawing wire passes through the through hole, and a limit ball is fixedly arranged on the part of the drawing wire passing through the end, so The diameter of the limiting ball is larger than the diameter of the through hole.
在其中一个实施方式中，所述支撑组件还包括连接在所述多根支撑杆远端的远端连接环，和连接在所述多根支撑杆近端的近端连接环，所述远端连接环与所述端头相连，所述近端连接环与所述导管主体相连。In one embodiment, the support assembly further includes a distal connecting ring connected to the distal ends of the plurality of support rods, and a proximal connecting ring connected to the proximal ends of the plurality of support rods, the distal ends A connecting ring is connected to the tip, and the proximal connecting ring is connected to the catheter body.
在其中一个实施方式中，所述支撑组件由单根金属管切割而成，所述多根支撑杆以所述导管主体的纵向中心轴线为对称轴对称分布。In one embodiment, the support assembly is cut from a single metal tube, and the plurality of support rods are symmetrically distributed with the longitudinal center axis of the catheter body as the axis of symmetry.
在其中一个实施方式中，每根支撑杆均包括近端倾斜部分、远端倾斜部分及连接于所述近端倾斜部分及远端倾斜部分之间的顶部，所述顶部包括与所述近端倾斜部分相连的近端弯折部、与所述远端倾斜部分相连的远端弯折部及位于所述近端弯折部及远端弯折部之间的顶部直段，所述注射针导向孔设于所述顶部，所述注射针导向孔至少部分位于所述近端弯折部及顶部直段上。In one of the embodiments, each support rod includes a proximal inclined portion, a distal inclined portion and a top portion connected between the proximal inclined portion and the distal inclined portion, the top portion including the proximal portion and the proximal inclined portion. A proximal bent portion connected to the inclined portion, a distal bent portion connected to the distal inclined portion, and a top straight section located between the proximal bent portion and the distal bent portion, the injection needle A guide hole is provided on the top, and the injection needle guide hole is at least partially located on the proximal bent portion and the straight section of the top.
在其中一个实施方式中，每根所述支撑杆均以其上的所述注射针导向孔的中心垂线呈轴对称分布。In one embodiment, each of the support rods is distributed axially symmetrically with respect to the center vertical line of the injection needle guide hole thereon.
在其中一个实施方式中，所述导管主体为多腔管，设有供所述注射针通行的注射针腔以及供所述拉丝通行的拉丝腔。In one embodiment, the catheter body is a multi-lumen tube, and is provided with an injection needle cavity for the injection needle to pass through and a wire drawing cavity for the drawing wire to pass through.
在其中一个实施方式中，所述拉丝腔的纵向中心线与所述导管主体的纵向中心轴线共线。In one embodiment, the longitudinal centerline of the wire draw lumen is collinear with the longitudinal centerline of the catheter body.
在其中一个实施方式中，所述腔内注射导管装置还包括设置在所述导管主体近端的手柄机构，所述手柄机构用于操控所述注射针的运动。In one of the embodiments, the intraluminal injection catheter device further comprises a handle mechanism disposed at the proximal end of the catheter body, the handle mechanism is used to control the movement of the injection needle.
在其中一个实施方式中，所述注射针的穿刺角度范围为30度至90度。In one embodiment, the puncture angle of the injection needle ranges from 30 degrees to 90 degrees.
在其中一个实施方式中，所述注射针具有针尖、穿刺段及主体段，所述穿刺段位于所述针尖及主体段之间，所述穿刺段的外径小于或者等于所述主体段的外径。In one embodiment, the injection needle has a needle tip, a puncturing section and a main body section, the puncturing section is located between the needle tip and the main body section, and the outer diameter of the puncturing section is smaller than or equal to the outer diameter of the main body section path.
上述腔内注射导管装置借助支撑组件为注射针提供引导及支撑，避免注射针在穿刺时偏移目标血管内皮位置，以利于可靠地完成注射针穿刺及介质注射。此外，支撑组件在拉丝作用下能够收缩和膨胀，且能够锁定在任一收缩或膨胀的状态，方便腔内注射导管装置的推送和取出。The above-mentioned intracavity injection catheter device provides guidance and support for the injection needle by means of the support assembly, so as to prevent the injection needle from deviating from the target vascular endothelium during puncturing, so as to facilitate the reliable completion of the injection needle puncture and medium injection. In addition, the support assembly can be contracted and expanded under the action of wire drawing, and can be locked in any contracted or expanded state, which is convenient for pushing and taking out the intraluminal injection catheter device.
附图说明Description of drawings
图1为现有的腔内注射导管装置的结构示意图；Fig. 1 is the structural representation of the existing intraluminal injection catheter device;
图2a为本发明实施方式提供的腔内注射导管装置的示意图；2a is a schematic diagram of an intraluminal injection catheter device provided by an embodiment of the present invention;
图2b为图2a中的腔内注射导管装置中的端头与支撑组件装配结构示意图；Fig. 2b is a schematic view of the assembly structure of the end head and the support assembly in the intraluminal injection catheter device in Fig. 2a;
图2c为沿图2b中的A-A线的剖面示意图；Figure 2c is a schematic cross-sectional view along the line A-A in Figure 2b;
图3a为图2b中的支撑组件、注射针导向管及注射针的剖面示意图；3a is a schematic cross-sectional view of the support assembly, the injection needle guide tube and the injection needle in FIG. 2b;
图3b为径向扩张后的支撑组件、注射针导向管及未被推送的注射针的结构示意图；Figure 3b is a schematic structural diagram of the radially expanded support assembly, the injection needle guide tube and the injection needle that has not been pushed;
图3c为径向扩张后的支撑组件、注射针导向管及被推送出注射针导向孔后的注射针的结构示意图；Figure 3c is a schematic structural diagram of the radially expanded support assembly, the injection needle guide tube, and the injection needle pushed out of the injection needle guide hole;
图4a-图4d为具有不同形状的注射针导向孔的示意图；4a-4d are schematic diagrams of injection needle guide holes with different shapes;
图5为沿图3b中B-B线的剖面示意图；Figure 5 is a schematic cross-sectional view along line B-B in Figure 3b;
图6a-图6c为不同实施方式中的支撑组件与端头的结构示意图；6a-6c are schematic structural diagrams of support components and ends in different embodiments;
图7a-图7c为图6c中的腔内注射导管装置在指引导管内输送过程中的各状态结构示意图；Figures 7a-7c are schematic structural diagrams of various states of the intraluminal injection catheter device in Figure 6c during the delivery process in the guiding catheter;
图7d为沿图7c中C-C线的剖面示意图，其中的注射机构被径向扩张且与血管相接触。Figure 7d is a schematic cross-sectional view taken along line C-C in Figure 7c, wherein the injection mechanism is radially expanded and in contact with the blood vessel.
具体实施方式Detailed ways
为使本发明的上述目的、特征和优点能够更加明显易懂，下面结合附图对本发明的具体实施方式做详细的说明。在下面的描述中阐述了很多具体细节以便于充分理解本发明。但是本发明能够以很多不同于在此描述的其它方式来实施，本领域技术人员可以在不违背本发明内涵的情况下做类似改进，因此本发明不受下面公开的具体实施的限制。In order to make the above objects, features and advantages of the present invention more clearly understood, the specific embodiments of the present invention will be described in detail below with reference to the accompanying drawings. In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present invention. However, the present invention can be implemented in many other ways different from those described herein, and those skilled in the art can make similar improvements without departing from the connotation of the present invention. Therefore, the present invention is not limited by the specific implementation disclosed below.
需要说明的是，在介入领域，通常将相对操作者近的一端称为近端，相对操作者远的一端称为远端。It should be noted that, in the field of intervention, the end that is closer to the operator is usually called the proximal end, and the end that is farther than the operator is called the distal end.
还需要说明的是，本实施方式以向肾动脉血管壁内注射介质来治疗高血压为例来对腔内注射导管装置进行详细说明，而本发明的腔内注射导管装置还可以应用在对其他疾病的治疗上，例如向血管壁注射药物以治疗与血管壁相关的疾病(例如动脉硬化、动脉瘤或闭塞病变等等)，也可以向气管壁、支气管壁、食道壁等管腔壁内注射抗癌药物杀死管腔周围的癌细胞，还可以通过冠状静脉窦向心肌细胞注射干细胞，以促进血管再生，改善心肌缺血的症状等等。It should also be noted that, in this embodiment, the intraluminal injection catheter device is described in detail by taking the injection of a medium into the renal artery vessel wall to treat hypertension as an example, and the intraluminal injection catheter device of the present invention can also be applied to other In the treatment of diseases, for example, injecting drugs into the blood vessel wall to treat diseases related to the blood vessel wall (such as arteriosclerosis, aneurysm or occlusive disease, etc.) Anticancer drugs kill cancer cells around the lumen, and stem cells can also be injected into cardiomyocytes through the coronary sinus to promote angiogenesis, improve symptoms of myocardial ischemia, and more.
除非另有定义，本文所使用的所有的技术和科学术语与属于本发明的技术领域的技术人员通常理解的含义相同。本文中在本发明的说明书中所使用的术语只是为了描述具体的实施方式的目的，不是旨在于限制本发明。本文所使用的术语“及/或”包括一个或多个相关的所列项目的任意的和所有的组合。Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. The terms used herein in the description of the present invention are for the purpose of describing specific embodiments only, and are not intended to limit the present invention. As used herein, the term "and/or" includes any and all combinations of one or more of the associated listed items.
如图2a所示为本发明揭示的一种腔内注射导管装置200。该腔内注射导管装置200包括导管主体250、注射机构220及手柄机构261。Figure 2a shows an intraluminal
其中，导管主体250为空心结构，呈细长管状，其包括远端210及近端260。远端210与注射机构220相连，近端260与手柄机构261相连。Wherein, the
同时参考图2a和图2b，注射机构220与导管主体250的远端210相连。所述注射机构220包括端头211、支撑组件230、拉丝270以及至少一根注射针241。Referring to Figures 2a and 2b simultaneously, the
注射针241呈细长管状，穿设进入导管主体250，且在导管主体250内延伸至导管主体250的近端260并与手柄机构261相连。The
所述拉丝270的远端穿出导管主体250并与端头211相连。所述拉丝270穿设支撑组件230、导管主体250，沿导管主体250延伸至导管主体250的近端260，进而使拉丝270的近端与手柄机构261相连。通过手柄机构261操作拉丝270带动端头211相对导管主体250运动，可控制支撑组件230的膨胀与收缩。The distal end of the
手柄机构261上设有注射针滑块263及鲁尔接头262。注射针滑块263与注射针241传动连接。该腔内注射导管装置200可通过注射针滑块263推送或回收注射针241。所述鲁尔接头262一端可与外部注射器连接，另一端则与注射针241流体相通，从而可将介质注射至注射针241内。The
图2b显示了该腔内注射导管装置200的注射机构220及导管主体250的部分结构，且所述注射机构220的支撑组件230在拉丝270的作用下，处于膨胀状态。FIG. 2 b shows a partial structure of the
导管主体250可设置为多腔管。在一实施方式中，如图2c所示为导管主体250沿图2b中A-A线的截面，在导管主体250内，包含三个供注射针241通行的注射针腔242及一个供拉丝270通行的拉丝腔271。拉丝腔271的纵向中心线与所述导管主体250的纵向中心轴线共线。注射针腔242沿导管主体250的中心轴线呈中心对称分布。The
支撑组件230的远端与端头211的近端连接，支撑组件230的近端与导管主体250的远端210连接。The distal end of the
所述支撑组件230包含近端连接环225、支撑杆221、支撑杆222、支撑杆223及远端连接环224。支撑杆221、222、223连接在近端连接环225与远端连接环224之间。近端连接环225与导管主体250采用合适的方式固定连接，例如可利用医用胶水粘连。远端连接环224与端头211采用合适的方式固定连接，例如可通过激光点焊焊接。The
支撑组件230可以由单根金属管经切割而形成。典型地，支撑组件230的材质为超弹性材料，例如镍钛材料，可在血管造影设备(DSA)中清晰地看到支撑组件230的轮廓。支撑组件230的支撑杆221、支撑杆222、支撑杆223在形状及结构上完全相同，彼此间隔120度，沿导管主体250的中心轴线202(图3a)呈中心对称分布。支撑杆221、222、223具有弹性，在外力作用下可弯折。支撑杆221、222、223上设有注射针导向孔226，支撑杆221的内表面连接有注射针导向管231，注射针导向管231内可通行注射针241，注射针导向孔226可供注射针241穿出。The
以支撑杆221为例，在输送状态，支撑杆221呈近似的直线；在膨胀状态，如图3a所示的支撑杆221的剖视图，支撑杆221的形状为近似的拱形，且注射针241被推出注射针导向孔226。支撑杆221包括近端倾斜部分279、顶部289及远端倾斜部分280。其中近端倾斜部分279包括底部弯折部281及直段282，远端倾斜部分280包括底部弯折部288及直段287，顶部289包括近端弯折部283、顶部直段284及远端弯折部286。弯折部的刚度要小于各直段的刚度，因此，当支撑杆221膨胀时，弯折部会先变形，而直段则在弯折部的拉动下运动，该设置有利于支撑杆221的变形，并且每次变形都能形成稳定一致的形状。本实施方式中，支撑杆221以其上的注射针导向孔226的中心垂线呈轴对称分布，因此不论腔内注射导管装置200处于何种状态，支撑杆221的顶部直段284都与中心轴线202近似的平行，顶部289位于支撑杆221的最高点。注射针导向孔226位于所述顶部289。更具体地，注射针导向孔226至少部分位于所述近端弯折部283及顶部直段284上。Taking the
图3b所示为支撑杆221装配结构的局部剖面图，此时腔内注射导管200的状态为，支撑杆221已膨胀，但注射针241还未被推送出注射针导向孔226。同时参考图3a和图3b，支撑杆221的近端倾斜部分279的内表面290上连接有注射针导向管231，注射针导向管231可由金属细管切割制成，例如不锈钢管、镍钛管等。注射针导向管231位于支撑杆221的近端倾斜部分279的内表面290，即，注射针导向管231位于支撑杆221与中心轴线202之间。3b shows a partial cross-sectional view of the assembly structure of the
注射针导向管231包括导向前孔292和导向后孔291。注射针241具有针尖293、穿刺段294、主体段295及注射内腔296。穿刺段294连接在主体段295的远端，针尖293设置在穿刺段294的远端，穿刺段294和主体段295内设置所述注射内腔296。主体段295在导管主体250内从远端向近端延伸，直至与手柄机构261的注射针滑块263相连，同时与手柄机构261上的鲁尔接头262流体连通。所述穿刺段294的外径小于或者等于所述主体段295的外径，以利于减小血管壁上的穿刺孔孔径，同时具有较大外径的主体段295也有利于注射针241的推送。The injection
可以理解的是，注射针导向管231的数量也可以小于支撑杆221的数量，可以根据需要来设计。还可以理解的是，注射针241的数量也可以小于导向管231的数量，可以根据需要来设计。在图3b所示的状态中，穿刺段294布置在注射针导向管231中，注射针241可在注射针导向管231内通行，但针尖293必不会超越注射针导向管231的导向后孔291。这可由手柄机构261上的注射针滑块263的行程限位来实现。It can be understood that, the number of the injection
支撑杆221在膨胀过程中，注射针导向管231亦随之运动，如图3c中所示，注射针导向管231中心轴线与导管主体250的中心轴线202之间的夹角θ，被定义为穿刺角度。支撑组件230能够获得的最大径向扩张直径，为支撑杆221近端倾斜部分279与中心轴线202垂直的时候，此时注射针导向管231与中心轴线202垂直，穿刺角度为90度。一般地，穿刺角度可在0～90度间变化。本实施方式的优选穿刺角度在30～90度之间。在该设置下，当针尖293抵达顶部289的下表面时，如图3b所示，针尖293的端面297位于注射针导向孔226的近端端面298的远端一侧；当针尖293超越顶部289的上表面时，如图3c所示，针尖293的端面297位于注射针导向孔226的远端端面299的近端一侧。因此，注射针241总能够穿过位于顶部289的注射针导向孔226，进而穿刺血管进行注射。During the expansion process of the
典型地，注射针导向孔226为跑道形，如图4a所示。在其他实施方式中，如图4b、图4c和图4d中所示，注射针导向孔226也可以是圆形，椭圆形或者其他狭长的形状。所述注射针导向孔226的轴向长度一般为0.2～5毫米，优选为1～2毫米；所述轴向长度为注射针导向孔226在平行于中心轴线202的方向上的最长长度。所述注射针导向孔226在垂直于中心轴线202的方向上的最大宽度一般为0.2～1毫米，优选为0.2～0.5毫米。Typically, the
图5为沿图3b中B-B线的截面示意图，示出支撑杆221的直段282的截面形状。直段282内表面的截面为自然的一段圆弧管227，有利于与注射针导向管231的固定。在本实施方式中，注射针导向管231与支撑杆221的固定方式采用锡焊，在注射针导向管231与支撑杆221内侧的缝隙内可填满焊锡228。FIG. 5 is a schematic cross-sectional view along the line B-B in FIG. 3 b , showing the cross-sectional shape of the
本实施方式中的腔内注射导管装置200不可通行导丝，在导丝与指引导管建立路径之后，指引导管到达注射针241穿刺点后，将导丝撤出指引导管，再沿指引导管推送该腔内注射导管装置200。The intraluminal
如图6a所示，一实施方式中的腔内注射导管装置200，其注射机构220的端头211为实心结构，端头211可通过激光点焊与注射机构220连接，具体地端头211可通过焊锡272与拉丝270固定连接。As shown in FIG. 6a, in an embodiment of the intracavity
如图6b所示，在另外的实施方式中，注射机构420中的端头411也可设置一个轴向的通孔412，拉丝470通过端头411朝远端伸出部分长度，作为腔内注射导管输送的导向段473。拉丝470仍通过焊锡472与端头411固定连接。所述导向段473表面附有保护层474，保护层474可以是亲水涂层或是柔软的硅胶层，以有利于减少对血管壁的伤害。As shown in Fig. 6b, in another embodiment, the
如图6c所示，在另外的实施方式中，注射机构520中的拉丝570也可不与端头511固定连接，而是采用另外的方式与端头511相连。所述端头511具有一轴向的通孔512，所述拉丝570在导向段573的近端设置一个限位球575，限位球575的直径大于通孔512的直径。当拉丝570朝近端拉动时，限位球575卡在端头511的通孔512内，注射机构520中的支撑组件受到拉丝570的作用而发生膨胀；当拉丝570朝远端运动时，则支撑组件恢复到初始收缩状态。所述限位球575一般为在DSA下可见的材质，例如铂金、铂合金等等。该设置有利于腔内注射导管装置在弯曲血管内的输送。As shown in FIG. 6c, in another embodiment, the
与上述实施方式中类似，所述导向段573表面也可附有保护层574。Similar to the above-mentioned embodiment, a
以下以图6c所示实施方式为例，结合图7a、图7b、图7c和图7d介绍本发明腔内注射导管装置500的操作过程。使用时，如图7a所示，操作者通过血管穿刺点建立输送路径，首先将导丝(未示出)送入肾动脉310，随后将指引导管/输送鞘320(guiding catheter)沿导丝输送入肾动脉口311，随后，将导丝撤出，送入带限位球575的拉丝570，此时拉丝570兼有导丝的导向作用，腔内注射导管装置500沿着拉丝570建立的路径，在指引导管320内输送。当腔内注射导管装置500在指引导管320内输送时，见图7a，注射机构520中的支撑组件530处于收缩状态。Taking the embodiment shown in Fig. 6c as an example, the operation process of the intraluminal
如图7b所示，当注射机构520中的支撑组件530被推出指引导管320时，支撑组件530仍处于收缩状态。操作者可在血管内继续推送腔内注射导管装置500，直至支撑组件530到达目标血管位置。此时，如果限位球575与端头511还有一定距离，可拉动拉丝570朝近端运动，直至限位球575卡在端头511的通孔512内；如果拉丝570的限位球575已卡在端头511的通孔512内，也即，若限位球575及端头511的位置关系如图7b中所示，则可直接拉动拉丝570，控制支撑组件530的膨胀。As shown in FIG. 7b, when the
图7c显示了支撑组件530的膨胀状态。如图7d中所示，膨胀后支撑组件530形成圆周的径向半径R2大于所定位处的血管半径R1，以提供径向支撑力。膨胀后支撑组件530所形成圆周的周向直径为腔内注射导管装置500的扩张尺寸。典型地，腔内注射导管装置500的扩张尺寸比目标血管直径要大0～4毫米，优选为2～4毫米。Figure 7c shows the
如图7d中所示，在支撑组件530处于膨胀状态下，推送注射针541，使得注射针541穿出相应的注射针导向孔226并抵达血管壁，继续推送注射针541，注射针541既可穿刺进入血管壁内膜层313、中膜层314及血管外壁315内，甚至可穿刺至血管外壁315外，到达交感神经330分布比较密集的部分，此时完成注射针541的推送。通过手柄机构上的鲁尔接头连接注射器，将注射器内的介质推入注射针541的注射内腔，介质进入血管组织并扩散，通过介质的神经毒性，消融血管壁312内及周围的神经。As shown in FIG. 7d, when the
与现有技术相比，本发明具有如下明显优势：Compared with the prior art, the present invention has the following obvious advantages:
(1)由于支撑组件为注射针提供引导及支撑，避免注射针在穿刺时偏移目标血管内皮位置，以利于可靠地完成注射针穿刺及介质注射。(1) Since the support assembly provides guidance and support for the injection needle, the injection needle can be prevented from deviating from the target vascular endothelium during puncture, so as to facilitate the reliable completion of the injection needle puncture and medium injection.
(2)支撑组件在拉丝作用下能够收缩和膨胀，且能够锁定在任一收缩或膨胀的状态，方便腔内注射导管装置的推送和取出。(2) The support assembly can be contracted and expanded under the action of wire drawing, and can be locked in any contracted or expanded state, which is convenient for pushing and taking out the intraluminal injection catheter device.
(3)本发明的腔内注射导管装置的导管主体设有互相隔离的注射针腔，可以有效地防止多根注射针在被推送时相互干扰。(3) The catheter body of the intraluminal injection catheter device of the present invention is provided with mutually isolated injection needle cavities, which can effectively prevent multiple injection needles from interfering with each other when being pushed.
(4)注射针导向孔位于支撑组件的支撑杆的顶部，当支撑组件膨胀时，注射针导向孔位于支撑杆的最高点，与血管壁接触，注射针导向管的导向前孔正对注射针导向孔，当注射针穿刺时，从注射针导向管的导向前孔推出即可进入注射针导向孔，从而可靠地完成血管壁穿刺及介质注射。(4) The injection needle guide hole is located at the top of the support rod of the support assembly. When the support assembly expands, the injection needle guide hole is located at the highest point of the support rod and is in contact with the blood vessel wall. The guide front hole of the injection needle guide tube faces the injection needle. The guide hole, when the injection needle is punctured, can be pushed out from the guide front hole of the injection needle guide tube to enter the injection needle guide hole, so as to reliably complete the puncture of the blood vessel wall and the injection of the medium.
以上所述实施方式的各技术特征可以进行任意的组合，为使描述简洁，未对上述实施方式中的各个技术特征所有可能的组合都进行描述，然而，只要这些技术特征的组合不存在矛盾，都应当认为是本说明书记载的范围。The technical features of the above-described embodiments can be combined arbitrarily. In order to simplify the description, all possible combinations of the technical features in the above-described embodiments are not described. However, as long as there is no contradiction between the combinations of these technical features, All should be regarded as the scope described in this specification.
以上所述实施方式仅表达了本发明的几种实施方式，其描述较为具体和详细，但并不能因此而理解为对发明专利范围的限制。应当指出的是，对于本领域的普通技术人员来说，在不脱离本发明构思的前提下，还可以做出若干变形和改进，这些都属于本发明的保护范围。因此，本发明专利的保护范围应以所附权利要求为准。The above-mentioned embodiments only represent several embodiments of the present invention, and the descriptions thereof are specific and detailed, but should not be construed as a limitation on the scope of the invention patent. It should be pointed out that for those of ordinary skill in the art, without departing from the concept of the present invention, several modifications and improvements can also be made, which all belong to the protection scope of the present invention. Therefore, the protection scope of the patent of the present invention should be subject to the appended claims.
Claims (15)
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