CN114569868A - Novel double-layer medicine balloon - Google Patents
Novel double-layer medicine balloonDownload PDFInfo
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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
- A61M25/0045—Catheters; Hollow probes characterised by structural features multi-layered, e.g. coated
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M25/104—Balloon catheters used for angioplasty
- 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
- A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
- A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
- 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
- A61M2025/0057—Catheters delivering medicament other than through a conventional lumen, e.g. porous walls or hydrogel coatings
- 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
- A61M2025/006—Catheters; Hollow probes characterised by structural features having a special surface topography or special surface properties, e.g. roughened or knurled surface
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M25/1011—Multiple balloon catheters
- A61M2025/1013—Multiple balloon catheters with concentrically mounted balloons, e.g. being independently inflatable
- 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
- A61M2025/105—Balloon catheters with special features or adapted for special applications having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
- 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
- A61M2025/1086—Balloon catheters with special features or adapted for special applications having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves
- 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
- A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
- A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
- A61M2037/0023—Drug applicators using microneedles
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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技术领域，尤其涉及一种新型双层药物球囊。The invention relates to the technical field of medical devices, in particular to a novel double-layer drug balloon.
背景技术Background technique
目前，冠状动脉手术基本用球囊替代支架，通常是两个球囊，一个是扩张球囊，一个是药物球囊，手术时扩张球囊通过充入特定物质对冠状动脉血管进行扩张，然后再用药物球囊进行上药。At present, balloons are basically used instead of stents in coronary surgery, usually two balloons, one is a dilation balloon and the other is a drug balloon. Dosing with a drug balloon.
但是，扩张球囊扩张血管一定时间后，由于惯性原因血管会收缩，而药物球囊的扩张作用目前适应症为：直径较小(2mm)冠脉病变，支架内再狭窄病变等，存在几点缺陷：1、药物球囊外层为固体药物涂层，弯曲能力小，通过弯曲角度大的冠脉血管的能力差；2、药物球囊到达目的部位后，扩张到一定直径大小持续60秒后撤压撤除，因此药物涂在特定部位的量不能确定，容易受血流和局部血管钙化等情况影响，给药剂量无法估计定量；3、药物球囊只能用一次，对于多处小冠脉血管病变不能做到反复给药，因此，药物球囊不具备较好的扩张功能，不能进行持续上药，影响治疗效果。However, after the expansion balloon dilates the blood vessel for a certain period of time, the blood vessel will contract due to inertia, and the current indications for the expansion of the drug balloon are: coronary artery disease with a small diameter (2mm), in-stent restenosis disease, etc. There are several points Defects: 1. The outer layer of the drug balloon is a solid drug coating, which has small bending ability and poor ability to pass through coronary vessels with a large bending angle; 2. After the drug balloon reaches the target site, it expands to a certain diameter for 60 seconds. The amount of the drug applied to a specific part cannot be determined, and it is easily affected by blood flow and local vascular calcification. Vascular lesions cannot be administered repeatedly. Therefore, the drug balloon does not have a good expansion function and cannot be continuously administered, which affects the therapeutic effect.
发明内容SUMMARY OF THE INVENTION
本发明的目的在于提供一种新型双层药物球囊，旨在解决现有技术中的扩张球囊扩张血管一定时间后，由于惯性原因血管会收缩，而药物球囊没有较好的扩张功能，因此不能进行持续上药，影响治疗效果的技术问题。The purpose of the present invention is to provide a novel double-layer drug balloon, which aims to solve the problem that after the expansion balloon in the prior art dilates the blood vessel for a certain period of time, the blood vessel will shrink due to inertia, and the drug balloon does not have a good expansion function. Therefore, continuous application of the drug cannot be carried out, which affects the technical problem of the therapeutic effect.
为实现上述目的，本发明采用的一种新型双层药物球囊，包括连通组件、扩张球囊、药物球囊、微针和疏通组件；In order to achieve the above object, a novel double-layer drug balloon adopted in the present invention includes a communication component, an expansion balloon, a drug balloon, a microneedle and a dredging component;
所述连通组件与所述药物球囊连通，所述扩张球囊位于所述药物球囊的内部，所述微针与所述药物球囊固定连接，并位于所述药物球囊的外壁，且与所述药物球囊的内部连通，所述疏通组件与所述药物球囊固定连接。The communication component is communicated with the drug balloon, the expansion balloon is located inside the drug balloon, the microneedle is fixedly connected with the drug balloon, and is located on the outer wall of the drug balloon, and In communication with the inside of the drug balloon, the dredging component is fixedly connected with the drug balloon.
所述连通组件用于向所述扩张球囊输送药物，并向所述扩张球囊输送特定物质，使所述扩张球囊扩张，所述扩张球囊位于所述药物球囊的内壁，进而带动所述药物球囊扩张，所述药物球囊外壁上具有所述微针，所述微针跟随所述药物球囊扩张，所述微针可以刺入血管一半的深度，进而药物可以注射入血管的内部，上药效果更佳，同时，由于所述扩张球囊在所述药物球囊的内部，边上药边扩张，进行持续上药，上药时间可控，促使治疗效果更佳。The communication component is used to deliver medicine to the expansion balloon, and to deliver a specific substance to the expansion balloon to expand the expansion balloon, and the expansion balloon is located on the inner wall of the medicine balloon, thereby driving The drug balloon is expanded, the outer wall of the drug balloon has the microneedle, the microneedle expands following the drug balloon, the microneedle can penetrate half the depth of the blood vessel, and the drug can be injected into the blood vessel In the inner part of the device, the effect of drug application is better, and at the same time, because the expansion balloon is inside the drug balloon, the drug is expanded while the drug is applied, and continuous drug application is performed, the drug application time is controllable, and the treatment effect is better.
其中，所述微针具有通孔，所述通孔贯穿所述微针，并与所述药物球囊的内部连通。Wherein, the microneedle has a through hole, and the through hole penetrates the microneedle and communicates with the inside of the drug balloon.
所述通孔供所述药物球囊中的药物输出。The through hole is used for outputting the medicine in the medicine balloon.
其中，所述扩张球囊具有多个内凹通道，多个所述内凹通道位于所述扩张球囊的表壁。Wherein, the expansion balloon has a plurality of concave channels, and the plurality of concave channels are located on the surface wall of the expansion balloon.
所述内凹通道使所述药物球囊和所述扩张球囊之间形成可供药物流通的通道。The concave channel forms a channel for drug circulation between the drug balloon and the dilation balloon.
其中，所述连通组件包括药物管道和扩充构件，所述药物管道与所述药物球囊连通；所述扩充构件与所述扩张球囊连通。Wherein, the communication assembly includes a drug pipeline and an expansion member, the drug pipeline communicates with the drug balloon; the expansion member communicates with the expansion balloon.
所述药物管道向所述药物球囊输送药物，所述扩张构件辅助所述扩张球囊扩张。The drug conduit delivers the drug to the drug balloon, and the expansion member assists in the expansion of the expansion balloon.
其中，所述扩充构件包括物质管道和控制部件，所述物质管道与所述扩张球囊连通，并伸入所述药物管道的内部；所述控制部件与所述药物管道连通。Wherein, the expansion member includes a substance pipeline and a control part, the substance pipeline communicates with the expansion balloon and extends into the inside of the drug pipeline; the control part communicates with the drug pipeline.
所述物质管道向所述扩张球囊内输送特定物质，使所述扩张球囊膨胀，进而带动所述药物球囊膨胀，扩张血管，所述控制部件用于控制特定物质的输送量。The substance pipeline transports a specific substance into the expansion balloon, so that the expansion balloon is inflated, and further drives the expansion of the drug balloon to dilate the blood vessel, and the control component is used to control the delivery amount of the specific substance.
其中，所述疏通组件包括前端管和导丝，所述前端管与所述药物球囊固定连接，并位于所述药物球囊远离所述药物管道的一侧；所述导丝与所述扩张球囊固定连接，并伸入所述前端管的内部。Wherein, the dredging assembly includes a front end tube and a guide wire, the front end tube is fixedly connected with the drug balloon, and is located on the side of the drug balloon away from the drug pipeline; the guide wire and the expansion The balloon is fixedly attached and extends into the interior of the front end tube.
所述前端管方便进入血管中，操作所述导丝为前端管的进入提供动力。The front-end tube facilitates entry into the blood vessel, and manipulation of the guide wire provides power for the entry of the front-end tube.
其中，所述新型双层药物球囊还包括加强筋，所述加强筋与所述药物管道固定连接，并位于所述药物管道的内壁。Wherein, the novel double-layer drug balloon further includes a reinforcing rib, which is fixedly connected with the drug pipeline and located on the inner wall of the drug pipeline.
所述加强筋增强所述药物管道的结构强度。The reinforcing rib enhances the structural strength of the drug pipeline.
本发明的新型双层药物球囊，通过所述连通组件向所述扩张球囊输送特定物质，使所述扩张球囊膨胀，所述扩张球囊设置在所述药物球囊的内部，进而带动所述药物球囊膨胀，使血管扩张，所述微针设置在所述药物球囊的外壁，跟随所述药物球囊膨胀，刺入血管一般的深度，再通过所述连通组件向所述药物球囊输送药物，进而药物通过所述微针注射入血管的内部，上药效果更佳，同时，所述扩张球囊设置在所述药物球囊的内部，实现边扩张边上药，持续上药，并上药时间可控，促使治疗效果更佳。In the novel double-layer drug balloon of the present invention, a specific substance is delivered to the expansion balloon through the communication component to inflate the expansion balloon, and the expansion balloon is arranged inside the drug balloon, thereby driving the expansion The drug balloon is inflated to dilate the blood vessel. The microneedles are arranged on the outer wall of the drug balloon, follow the expansion of the drug balloon, pierce the blood vessel to a general depth, and then pass the communication component to the drug. The medicine is delivered by the balloon, and then the medicine is injected into the inside of the blood vessel through the microneedle, and the effect of applying medicine is better. Drugs, and the time of drug application is controllable, so that the treatment effect is better.
附图说明Description of drawings
为了更清楚地说明本发明实施例或现有技术中的技术方案，下面将对实施例或现有技术描述中所需要使用的附图作简单地介绍，显而易见地，下面描述中的附图仅仅是本发明的一些实施例，对于本领域普通技术人员来讲，在不付出创造性劳动的前提下，还可以根据这些附图获得其他的附图。In order to illustrate the embodiments of the present invention or the technical solutions in the prior art more clearly, the following briefly introduces the accompanying drawings that need to be used in the description of the embodiments or the prior art. Obviously, the drawings in the following description are only These are some embodiments of the present invention. For those of ordinary skill in the art, other drawings can also be obtained according to these drawings without creative efforts.
图1是本发明的新型双层药物球囊的结构示意图。FIG. 1 is a schematic structural diagram of the novel double-layer drug balloon of the present invention.
图2是本发明的新型双层药物球囊的剖视图。Figure 2 is a cross-sectional view of the novel bilayer drug balloon of the present invention.
图3是本发明的扩张球囊的结构示意图。FIG. 3 is a schematic structural diagram of the expansion balloon of the present invention.
图4是本发明的图2的A处放大图。Fig. 4 is an enlarged view of part A of Fig. 2 of the present invention.
图5是本发明的图2的B处放大图。FIG. 5 is an enlarged view of part B of FIG. 2 of the present invention.
图6是本发明的通孔的放大图。FIG. 6 is an enlarged view of the through hole of the present invention.
1-扩张球囊、2-药物球囊、3-微针、4-加强筋、10-连通组件、11-药物管道、12-扩充构件、20-疏通组件、21-前端管、22-导丝、100-新型双层药物球囊、101-内凹通道、121-物质管道、122-控制部件、123-伸缩罩、301-通孔、1221-输送管、1222-阀门。1-Dilation Balloon, 2-Drug Balloon, 3-Microneedle, 4-Reinforcing Rib, 10-Connecting Component, 11-Drug Pipeline, 12-Expansion Member, 20-Dredging Component, 21-Front End Tube, 22-Guide Silk, 100-new double-layer drug balloon, 101-concave channel, 121-substance pipeline, 122-control part, 123-expandable cover, 301-through hole, 1221-delivery tube, 1222-valve.
具体实施方式Detailed ways
下面详细描述本发明的实施例，所述实施例的示例在附图中示出，其中自始至终相同或类似的标号表示相同或类似的元件或具有相同或类似功能的元件。下面通过参考附图描述的实施例是示例性的，旨在用于解释本发明，而不能理解为对本发明的限制。The following describes in detail the embodiments of the present invention, examples of which are illustrated in the accompanying drawings, wherein the same or similar reference numerals refer to the same or similar elements or elements having the same or similar functions throughout. The embodiments described below with reference to the accompanying drawings are exemplary, and are intended to explain the present invention and should not be construed as limiting the present invention.
在本发明的描述中，需要理解的是，术语“长度”、“宽度”、“上”、“下”、“前”、“后”、“左”、“右”、“竖直”、“水平”、“顶”、“底”“内”、“外”等指示的方位或位置关系为基于附图所示的方位或位置关系，仅是为了便于描述本发明和简化描述，而不是指示或暗示所指的装置或元件必须具有特定的方位、以特定的方位构造和操作，因此不能理解为对本发明的限制。此外，在本发明的描述中，“多个”的含义是两个或两个以上，除非另有明确具体的限定。In the description of the present invention, it should be understood that the terms "length", "width", "upper", "lower", "front", "rear", "left", "right", "vertical", The orientations or positional relationships indicated by "horizontal", "top", "bottom", "inside", "outside", etc. are based on the orientations or positional relationships shown in the accompanying drawings, which are only for the convenience of describing the present invention and simplifying the description, rather than An indication or implication that the referred device or element must have a particular orientation, be constructed and operate in a particular orientation, is not to be construed as a limitation of the invention. In addition, in the description of the present invention, "plurality" means two or more, unless otherwise expressly and specifically defined.
请参阅图1、图3、图5和图6，本发明提供了一种新型双层药物球囊100，包括连通组件10、扩张球囊1、药物球囊2、微针3和疏通组件20；Please refer to FIG. 1 , FIG. 3 , FIG. 5 and FIG. 6 , the present invention provides a novel double-
所述连通组件10与所述药物球囊2连通，所述扩张球囊1位于所述药物球囊2的内部，所述微针3与所述药物球囊2固定连接，并位于所述药物球囊2的外壁，且与所述药物球囊2的内部连通，所述疏通组件20与所述药物球囊2固定连接。The
进一步地，请参阅图5和图6，所述微针3具有通孔301，所述通孔301贯穿所述微针3，并与所述药物球囊2的内部连通。Further, please refer to FIG. 5 and FIG. 6 , the
进一步地，请参阅图3，所述扩张球囊1具有多个内凹通道101，多个所述内凹通道101位于所述扩张球囊1的表壁。Further, please refer to FIG. 3 , the
在本实施方式中，所述连通组件10向所述药物球囊2输送药物，并向所述扩张球囊1输送特定物质，所述扩张球囊1设置在所述药物球囊2的内部，因输送进特定物质而膨胀，带动所述药物球囊2膨胀，所述微针3设置在所述药物球囊2的外壁，跟随所述药物球囊2扩张，进入血管的一半位置，再利用所述连通组件10向所述药物球囊2输送药物，所述扩张球囊1上具有的多个所述内凹通道101，使所述药物球囊2和所述扩张球囊1之间形成可供药物流通的通道，进而药物进入所述微针3中，因所述微针3具有的所述通孔301流出，注射入血管内部，促使上药效果更佳，同时，因所述扩张球囊1设置在所述药物球囊2内部，实现边扩张边上药，上药时间可控，促使治疗效果更佳，所述疏通组件20辅助球囊进入血管中，有利于上药，在目前所述扩张球囊1基础上外层加上给药途径，包括所述连通组件10、所述药物球囊2、所述微针3，这样可以利用目前球囊的特定实现球囊定位扩张，也可以实现给药量化、重复给药、不惧弯曲给药等优点。In this embodiment, the
进一步地，请参阅图1和图5，所述连通组件10包括药物管道11和扩充构件12，所述药物管道11与所述药物球囊2连通；所述扩充构件12与所述扩张球囊1连通。Further, please refer to FIG. 1 and FIG. 5 , the
进一步地，请参阅图1、图3、图4和图5，所述扩充构件12包括物质管道121和控制部件122，所述物质管道121与所述扩张球囊1连通，并伸入所述药物管道11的内部；所述控制部件122与所述药物管道11连通。Further, please refer to FIG. 1 , FIG. 3 , FIG. 4 and FIG. 5 , the expansion member 12 includes a
进一步地，请参阅图1和图4，所述控制部件122包括输送管1221和阀门1222，所述输送管1221与所述物质管道121连通，并位于所述物质管道121远离所述药物管道11的一侧；所述阀门1222与所述输送管1221固定连接，并位于所述输送管1221远离所述物质管道121的一侧。Further, please refer to FIG. 1 and FIG. 4 , the
进一步地，请参阅图5，所述扩充构件12还包括伸缩罩123，所述伸缩罩123位于所述药物球囊2与所述扩张球囊1之间。Further, referring to FIG. 5 , the expansion member 12 further includes a
在本实施方式中，所述药物管道11与所述药物球囊2连通，向所述药物球囊2中输送药物，所述物质管道121伸入所述药物管道11中，并与所述扩张球囊1连通，用于输送特定物质，使所述扩张球囊1膨胀，进而带动所述药物球囊2膨胀，扩张血管，方便上药，所述输送管1221与所述物质管道121连通，位于所述物质管道121远离所述药物管道11的一端，利用所述输送管1221，方便向所述物质管道121输送特定物质，所述阀门1222型号为KTS-F，控制所述输送管1221的开启和关闭，方便控制特定物质的输送量，有利于调节所述扩张球囊1的碰撞大小，促使上药效果更佳；所述伸缩罩123采用多根镍钛合金丝制成，编织成具有菱形通孔301的环形网状，相交的两根镍钛合金丝可活动，罩设在所述扩张球囊1的外侧，跟随所述扩张球囊1膨胀和收缩，增大所述扩张球囊1的扩张强度，进而带动所述药物球囊2更好的扩张，有利于提高上药效果，促使治疗效果更佳。In this embodiment, the
进一步地，请参阅图1、图4和图5，所述疏通组件20包括前端管21和导丝22，所述前端管21与所述药物球囊2固定连接，并位于所述药物球囊2远离所述药物管道11的一侧；所述导丝22与所述扩张球囊1固定连接，并伸入所述前端管21的内部。Further, please refer to FIG. 1 , FIG. 4 and FIG. 5 , the
在本实施方式中，所述前端管21固定在所述药物球囊2的前端，并呈锥状，方便进入血管中，所述导丝22伸入所述物质管道121中，穿过所述扩张球囊1，与所述扩张球囊1固定连接，并伸入所述前端管21中，为所述前端管21的进入提供动力，使所述药物球囊2更方便到达设定位置，进而有利于上药，促使治疗效果更佳。In this embodiment, the
进一步地，请参阅图4和图5，所述新型双层药物球囊100还包括加强筋4，所述加强筋4与所述药物管道11固定连接，并位于所述药物管道11的内壁。Further, please refer to FIG. 4 and FIG. 5 , the novel double-
在本实施方式中，所述加强筋4嵌设在所述药物管道11的内壁，增强所述药物管道11的结构强度，并所述药物管道11与所述物质管道121之间具有容置空间，供药物流通，有利于上药，促使治疗效果更佳。In this embodiment, the reinforcing
以上所揭露的仅为本发明一种较佳实施例而已，当然不能以此来限定本发明之权利范围，本领域普通技术人员可以理解实现上述实施例的全部或部分流程，并依本发明权利要求所作的等同变化，仍属于发明所涵盖的范围。The above disclosure is only a preferred embodiment of the present invention, and of course, it cannot limit the scope of rights of the present invention. Those of ordinary skill in the art can understand that all or part of the process of implementing the above embodiment can be realized according to the rights of the present invention. The equivalent changes required to be made still belong to the scope covered by the invention.
Claims (7)
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