技术领域technical field
本发明涉及医疗器械技术领域，更具体地说，涉及一种用于治疗支架内再狭窄的药物球囊。The invention relates to the technical field of medical devices, and more specifically relates to a drug balloon for treating restenosis in a stent.
背景技术Background technique
心脑血管疾病已经成为全世界第一大死因。目前，针对缺血性心脏病的治疗方法主要有三种：使用药物的基础治疗、进行冠脉搭桥的手术治疗、通过置入冠脉支架等从而解除冠脉狭窄的介入治疗。上述几种治疗方法在治疗冠状动脉狭窄方面都取得了明显的效果，但各自仍存在一些显著的问题。Cardiovascular and cerebrovascular diseases have become the number one cause of death in the world. At present, there are three main treatment methods for ischemic heart disease: basic treatment with drugs, surgical treatment with coronary artery bypass grafting, and interventional treatment for relieving coronary stenosis by placing coronary stents. The above-mentioned several treatment methods have achieved obvious effects in the treatment of coronary artery stenosis, but each still has some significant problems.
其中，冠脉支架植入术是将支架系统通过穿刺介入的方式输送到目标区域，球囊扩张释放支架，撑开狭窄病变血管，恢复血供，治疗缺血性心脏病。然而支架长期处于人体内，会刺激机体产生免疫排斥反应，平滑肌细胞过度增生造成内膜增厚，引起管腔丢失、降低管腔通畅率，进而影响血供，威胁患者的生命健康安全。为此，针对支架内再狭窄病变，需要对患者进行二次介入手术，重新支撑起再狭窄病变血管，恢复血流畅通，挽救患者生命。Among them, coronary stent implantation is to deliver the stent system to the target area through puncture and intervention, and the balloon expands to release the stent, open the narrowed and diseased blood vessel, restore the blood supply, and treat ischemic heart disease. However, if the stent stays in the human body for a long time, it will stimulate the body to produce immune rejection. The excessive proliferation of smooth muscle cells will cause the thickening of the intima, cause the loss of the lumen, reduce the patency of the lumen, and then affect the blood supply, threatening the life, health and safety of patients. Therefore, for in-stent restenosis, it is necessary to perform a second interventional operation on the patient to re-support the restenotic vessel, restore blood flow, and save the patient's life.
目前临床上针对支架再狭窄病变的治疗方式主要包括传统PTA球囊、血管支架和药物球囊等方式。At present, the clinical treatment methods for stent restenosis mainly include traditional PTA balloons, vascular stents, and drug balloons.
药物球囊在传统PTA球囊的表面覆盖了用于抑制平滑肌细胞过度增生的药物，降低再狭窄发生率，但目前的药物球囊针对支架内再狭窄病变给药药物含量过低，则对平滑肌细胞的抑制作用不足，远期管腔通畅率下降；药物含量过高，则机体的药物总量会造成毒性反应。The surface of the traditional PTA balloon is covered with drugs for inhibiting the excessive proliferation of smooth muscle cells to reduce the incidence of restenosis. If the inhibitory effect of cells is insufficient, the long-term lumen patency rate will decrease; if the drug content is too high, the total amount of drugs in the body will cause toxic reactions.
综上所述，对支架内再狭窄病变而言，采用药物球囊时，如何更有效地抑制支架近端和/或远端平滑肌细胞过度增生，提高远期管腔通畅率，保证治疗效果，同时降低整段病变的药物总含量，进而减小机体药物毒性和不良反应，是目前本领域技术人员急需解决的问题。In summary, for in-stent restenosis, how to more effectively inhibit the excessive proliferation of smooth muscle cells at the proximal and/or distal end of the stent when using drug balloons, improve the long-term lumen patency rate, and ensure the therapeutic effect, Simultaneously reducing the total drug content of the entire lesion, thereby reducing drug toxicity and adverse reactions in the body, is an urgent problem to be solved by those skilled in the art.
发明内容Contents of the invention
有鉴于此，本发明的目的在于提供一种治疗支架内再狭窄的药物球囊，该药物球囊的结构设计可以有效地解决现有药物球囊植入人体后，针对支架内再狭窄病变给药，药物含量过低，对平滑肌细胞的抑制作用不足，远期管腔通畅率下降；药物含量过高，则机体的药物总量会造成毒性反应的问题。In view of this, the object of the present invention is to provide a drug balloon for treating in-stent restenosis. If the drug content is too low, the inhibitory effect on smooth muscle cells will be insufficient, and the long-term lumen patency rate will decrease; if the drug content is too high, the total amount of drugs in the body will cause the problem of toxic reactions.
为了达到上述目的，本发明提供如下技术方案：In order to achieve the above object, the present invention provides the following technical solutions:
一种药物球囊，包括球囊和位于所述球囊表面的药物涂层，所述药物涂层包括药物和赋形剂；所述药物涂层包括近端涂层、中段涂层和远端涂层，所述近端涂层与所述远端涂层中一者的载药密度大于所述中段涂层的载药密度，另一者的载药密度不小于所述中段涂层的载药密度。A drug balloon, comprising a balloon and a drug coating on the surface of the balloon, the drug coating includes a drug and an excipient; the drug coating includes a proximal coating, a middle coating and a distal coating coating, the drug-loading density of one of the proximal coating and the distal coating is greater than the drug-loading density of the middle coating, and the drug-loading density of the other is not less than that of the middle coating. drug density.
优选地，上述药物球囊中，所述近端涂层、所述中段涂层和所述远端涂层顺序连接，分布于所述球囊外表面。Preferably, in the above drug balloon, the proximal coating, the middle coating and the distal coating are sequentially connected and distributed on the outer surface of the balloon.
优选地，上述药物球囊中，所述药物为紫杉醇、多烯紫杉醇、雷帕霉素、雷帕霉素及其衍生物、他汀类药物、阿司匹林、华法林、肝素、低分子肝素和西洛它唑中的一种或几种。Preferably, in the above drug balloon, the drug is paclitaxel, docetaxel, rapamycin, rapamycin and its derivatives, statins, aspirin, warfarin, heparin, low molecular weight heparin and western medicine One or more of lotazol.
优选地，上述药物球囊中，所述赋形剂为碘海醇、硬脂酸镁、碘普罗胺、尿素、聚乙二醇、聚山梨酯、山梨糖醇、丁酰基三己基柠檬酸酯、乙酰基柠檬酸三丁酯、有机酯、虫胶和月桂酸中的一种或几种。Preferably, in the above drug balloon, the excipients are iohexol, magnesium stearate, iopromide, urea, polyethylene glycol, polysorbate, sorbitol, butyryl trihexyl citrate , one or more of acetyl tributyl citrate, organic esters, shellac and lauric acid.
优选地，上述药物球囊中，所述药物涂层的载药密度为0.1-9.0ug/mm2。Preferably, in the above-mentioned drug balloon, the drug-loading density of the drug coating is 0.1-9.0 ug/mm2 .
优选地，上述药物球囊中，所述药物涂层的厚度为1-100um。Preferably, in the above drug balloon, the thickness of the drug coating is 1-100um.
优选地，上述药物球囊中，所述药物涂层的厚度为2-50um。Preferably, in the above drug balloon, the thickness of the drug coating is 2-50um.
优选地，上述药物球囊中，所述球囊采用尼龙、改性尼龙、尼龙弹性体和线形低密度聚乙烯几种材料中的一种或几种。Preferably, in the above drug balloon, the balloon is made of one or more materials selected from nylon, modified nylon, nylon elastomer and linear low-density polyethylene.
优选地，上述药物球囊中，所述药物涂层为将药物和赋形剂与四氢呋喃、乙醇和乙腈中的一种或几种进行混合，通过喷涂、浸渍、液滴、刷涂的方式将混合液涂覆在球囊表面，经过风干获得药物涂层。Preferably, in the above drug balloon, the drug coating is to mix the drug and excipients with one or more of tetrahydrofuran, ethanol and acetonitrile, and apply the drug by spraying, dipping, droplet, or brushing. The mixed solution is coated on the surface of the balloon and air-dried to obtain a drug coating.
优选地，上述药物球囊中，所述球囊包括顺次连接的球囊近端部、球囊中段部和球囊远端部，所述近端涂层位于所述球囊近端部表面、所述中段涂层位于所述球囊中段部表面、所述远端涂层位于所述球囊远端部表面，且充压状态下，所述球囊近端部与所述球囊远端部中一者的直径大于所述球囊中段部的直径，另一者的直径不小于所述球囊中段部的直径。Preferably, in the above drug balloon, the balloon includes a balloon proximal portion, a balloon mid-section, and a balloon distal portion connected in sequence, and the proximal coating is located on the surface of the balloon proximal portion , the middle coating is located on the surface of the middle section of the balloon, the distal coating is located on the surface of the distal end of the balloon, and in a pressurized state, the proximal end of the balloon and the distal end of the balloon One of the ends has a diameter greater than that of the midsection of the balloon, and the other has a diameter not smaller than that of the midsection of the balloon.
本发明提供的药物球囊包括球囊和药物涂层，药物涂层涂覆于球囊表面，包括药物和赋形剂。其中，药物涂层包括位于球囊近端的近端涂层、位于球囊中段的中段涂层和位于球囊远端的远端涂层。近端涂层与远端涂层中一者的载药密度大于中段涂层的载药密度，另一者的载药密度不小于中段涂层的载药密度。The drug balloon provided by the invention includes a balloon and a drug coating, and the drug coating is coated on the surface of the balloon and includes drugs and excipients. Wherein, the drug coating includes a proximal coating located at the proximal end of the balloon, a mid-section coating located at the middle section of the balloon, and a distal coating located at the distal end of the balloon. The drug-loading density of one of the proximal coating and the distal coating is greater than that of the middle coating, and the drug-loading density of the other is not less than that of the middle coating.
支架内再狭窄病变中，支架近端和/或远端部分的血管平滑肌细胞增生最为严重，来自血管的径向载荷最大。本发明提供的药物球囊，近端涂层与远端涂层中一者的载药密度大于中段涂层的载药密度，另一者的载药密度不小于中段涂层的载药密度。因而，根据影像学反馈，判断严重再狭窄发生在病变近端或远端中的一处或两处，选择本发明中的药物球囊进行充压，对重点区域选择性给药，保证支架近端和/或远端的严重病变处的药物含量相对更高，更有效地抑制平滑肌细胞过度增生，提高远期管腔通畅率，保证治疗效果，同时降低整段病变的药物总含量，进而减小机体药物毒性和不良反应。In stent restenosis lesions, the proliferation of vascular smooth muscle cells in the proximal and/or distal parts of the stent is the most serious, and the radial load from the blood vessel is the largest. In the drug balloon provided by the present invention, the drug-loading density of one of the proximal coating and the distal coating is greater than that of the middle coating, and the drug-loading density of the other is not less than that of the middle coating. Therefore, according to imaging feedback, it is judged that severe restenosis occurs at one or two of the proximal end or the distal end of the lesion, and the drug balloon in the present invention is selected for inflation, and selective administration of drugs is given to key areas to ensure that the stent is close to the lesion. The drug content in severe lesions at the distal end and/or distal end is relatively higher, which can more effectively inhibit the excessive proliferation of smooth muscle cells, improve the long-term lumen patency rate, ensure the therapeutic effect, and reduce the total drug content of the entire lesion, thereby reducing the Small body drug toxicity and adverse effects.
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 more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the following will briefly introduce the drawings that need to be used in the description of the embodiments or the prior art. Obviously, the accompanying drawings in the following description are only These are some embodiments of the present invention. Those skilled in the art can also obtain other drawings based on these drawings without creative work.
图1(a)-(b)分别是本发明实施例一和实施例二中药物球囊的结构示意图；Fig. 1 (a)-(b) are respectively the structural schematic diagrams of the drug balloon in the first embodiment and the second embodiment of the present invention;
图2(a)-(b)分别是本发明实施例一和实施例二中药物涂层的结构示意图；Fig. 2 (a)-(b) are respectively the structural representations of the drug coating in Embodiment 1 and Embodiment 2 of the present invention;
图3是本发明实施例一和实施例二中药物球囊横截面的结构示意图；Fig. 3 is a schematic structural view of the cross-section of the drug balloon in Embodiment 1 and Embodiment 2 of the present invention;
图4(a)-(b)分别是本发明实施例一和实施例二中支架内再狭窄病变的结构示意图；Figure 4(a)-(b) are the structural schematic diagrams of in-stent restenosis lesions in Embodiment 1 and Embodiment 2 of the present invention, respectively;
图5(a)-(b)分别是本发明实施例一和实施例二中，药物球囊被输送到支架内再狭窄病变处的结构示意图；Figure 5(a)-(b) are respectively the structural schematic diagrams of the drug balloon being delivered to the restenosis lesion in the stent in Embodiment 1 and Embodiment 2 of the present invention;
图6(a)-(b)分别是本发明实施例一和实施例二，药物球囊在支架内再狭窄病变处充压时的结构示意图。Fig. 6(a)-(b) are respectively the schematic diagrams of the structure of the drug balloon inflating the in-stent restenosis lesion in Embodiment 1 and Embodiment 2 of the present invention.
附图中标记如下：The markings in the attached drawings are as follows:
药物球囊-1；支架内再狭窄病变-2；球囊-10；药物涂层-11；近端涂层-110；中段涂层-111；远端涂层-112；药物-113；赋形剂-114；支架内再狭窄病变近端-20；支架内再狭窄病变中段-21；支架内再狭窄病变远端-22；原植入的支架-23。Drug-Balloon-1; In-Stent Restenosis-2; Balloon-10; Drug-Coating-11; Proximal Coating-110; Mid-Coating-111; Distal Coating-112; Formulation-114; proximal end of in-stent restenosis lesion-20; mid-section of in-stent restenosis lesion-21; distal end of in-stent restenosis lesion-22; original implanted stent-23.
具体实施方式Detailed ways
本发明实施例公开了一种药物球囊，以更有效地抑制支架近端和/或远端平滑肌细胞过度增生，提高远期管腔通畅率，保证治疗效果，同时降低整段病变的药物总含量，进而减小机体药物毒性和不良反应。The embodiment of the present invention discloses a drug balloon, which can more effectively inhibit the excessive proliferation of smooth muscle cells at the proximal end and/or distal end of the stent, improve the long-term lumen patency rate, ensure the therapeutic effect, and reduce the total amount of drugs for the entire lesion. content, thereby reducing the body's drug toxicity and adverse reactions.
下面将结合本发明实施例中的附图，对本发明实施例中的技术方案进行清楚、完整地描述，显然，所描述的实施例仅仅是本发明一部分实施例，而不是全部的实施例。基于本发明中的实施例，本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例，都属于本发明保护的范围。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。The following will clearly and completely describe the technical solutions in the embodiments of the present invention with reference to the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are only some, not all, embodiments of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by persons of ordinary skill in the art without making creative efforts belong to the protection scope of the present invention. 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.
本申请的核心思想为通过对药物球囊的结构改进，不同位置药物涂层对病变区域选择性给药。使用时，根据影像学反馈，判断严重再狭窄发生在病变近端或远端中的一处或两处，选择本发明中的药物球囊进行充压，对重点区域选择性给药，保证支架近端和/或远端的严重病变处的药物含量相对更高，更有效地抑制平滑肌细胞过度增生，提高远期管腔通畅率，保证治疗效果，同时降低整段病变的药物总含量，进而减小机体药物毒性和不良反应。The core idea of the present application is to improve the structure of the drug balloon, and the drug coating at different positions can selectively administer drugs to the lesion area. When in use, according to imaging feedback, it is judged that severe restenosis occurs at one or two of the proximal end or the distal end of the lesion, and the drug balloon in the present invention is selected for inflation, and selective administration is made to key areas to ensure that the stent The drug content in severe proximal and/or distal lesions is relatively higher, which can more effectively inhibit the excessive proliferation of smooth muscle cells, improve the long-term lumen patency rate, ensure the therapeutic effect, and reduce the total drug content of the entire lesion, thereby Reduce drug toxicity and adverse reactions in the body.
以下以两个具体的实施例进行说明。Two specific examples are used for description below.
实施例(一)Embodiment (1)
请参考图1(a)，2(a)和图3。图1(a)为本发明实施例一中药物球囊1的结构示意图；图2(a)为药物涂层11的结构示意图；图3为药物球囊1横截面的结构示意图。该实施中，药物球囊1包括球囊10和药物涂层11。Please refer to Figure 1(a), 2(a) and Figure 3. Figure 1(a) is a schematic structural view of the drug balloon 1 in Example 1 of the present invention; Figure 2(a) is a schematic structural view of the drug coating 11; Figure 3 is a schematic structural view of the cross section of the drug balloon 1. In this implementation, the drug balloon 1 includes a balloon 10 and a drug coating 11 .
其中，药物涂层11位于球囊表面，包括药物113和赋形剂114。药物涂层11包括近端涂层110、中段涂层111和远端涂层112，且近端涂层110、中段涂层111和远端涂层112顺序排布连接，分布于球囊10的外表面。近端涂层110中的载药密度大于中段涂层中111的载药密度，远端涂层112中的载药密度大于中段涂层111中的载药密度。需要说明的是，近端涂层110和远端涂层112分别位于中段涂层111的两端，具体近端与远端仅为了区分中段涂层111相对的两端，并无绝对远近关系的限定。在该实施例中，近端涂层110和远端涂层112的载药密度均大于中段涂层111的载药密度，具体二者的载药密度可以相等。根据需要，也包括近端涂层110和远端涂层112的载药密度均大于中段涂层111的载药密度，但二者的载药密度不相等，以适用于支架内再狭窄病变两端平滑肌细胞增生程度不同的情况。在其他实施例中，近端涂层110、中段涂层111和远端涂层112也可以呈不连接的间断式结构。Wherein, the drug coating 11 is located on the surface of the balloon and includes a drug 113 and an excipient 114 . The drug coating 11 includes a proximal coating 110, a middle coating 111 and a distal coating 112, and the proximal coating 110, the middle coating 111 and the distal coating 112 are sequentially arranged and connected, distributed on the balloon 10 The outer surface. The drug loading density in the proximal coating 110 is greater than that in the middle coating 111 , and the drug loading density in the distal coating 112 is greater than that in the middle coating 111 . It should be noted that the proximal coating 110 and the distal coating 112 are respectively located at the two ends of the middle coating 111, and the specific proximal and distal are only for distinguishing the opposite ends of the middle coating 111, and there is no absolute distance relationship. limited. In this embodiment, the drug-loading densities of the proximal coating 110 and the distal coating 112 are both greater than that of the middle coating 111 , specifically, the drug-loading densities of the two may be equal. According to requirements, the drug-loading density of the proximal coating 110 and the distal coating 112 is greater than that of the middle coating 111, but the drug-loading densities of the two are not equal, so as to be suitable for both in-stent restenosis lesions. Different degrees of smooth muscle cell proliferation. In other embodiments, the near-end coating 110 , the middle-section coating 111 and the distal coating 112 may also be in an intermittent structure that is not connected.
具体的，球囊10采用尼龙弹性体材料。根据需要，球囊也可以为尼龙、改性尼龙和线形低密度聚乙烯几种材料中的一种或几种。Specifically, the balloon 10 is made of nylon elastomer material. According to requirements, the balloon can also be one or more of several materials including nylon, modified nylon and linear low-density polyethylene.
具体的，药物涂层11中，药物113为雷帕霉素。根据需要，也可以为紫杉醇、多烯紫杉醇、雷帕霉素衍生物、他汀类药物、阿司匹林、华法林、肝素、低分子肝素和西洛它唑中的一种或几种。Specifically, in the drug coating 11, the drug 113 is rapamycin. According to needs, it can also be one or more of paclitaxel, docetaxel, rapamycin derivatives, statins, aspirin, warfarin, heparin, low molecular weight heparin and cilostazol.
具体的，药物涂层11中，赋形剂114为聚山梨酯。根据需要，也可以为碘海醇、硬脂酸镁、碘普罗胺、尿素、聚乙二醇、山梨糖醇、丁酰基三己基柠檬酸酯、乙酰基柠檬酸三丁酯、有机酯、虫胶和月桂酸中的一种或几种Specifically, in the drug coating 11, the excipient 114 is polysorbate. If necessary, iohexol, magnesium stearate, iopromide, urea, polyethylene glycol, sorbitol, butyryl trihexyl citrate, acetyl tributyl citrate, organic esters, insecticides One or more of gum and lauric acid
具体的，药物涂层11中，药物涂层11的载药密度为0.1-9.0ug/mm2，优选为0.5-5.0ug/mm2，最优选为2.0-4.0ug/mm2。需要说明的是，近端涂层110、中段涂层111和远端涂层112均应满足上述数值范围，且近端涂层110中的载药密度大于中段涂层中111的载药密度，远端涂层112中的载药密度大于中段涂层111中的载药密度。Specifically, in the drug coating 11, the drug loading density of the drug coating 11 is 0.1-9.0 ug/mm2 , preferably 0.5-5.0 ug/mm2 , most preferably 2.0-4.0 ug/mm2 . It should be noted that the proximal coating 110, the middle coating 111 and the distal coating 112 should all meet the above numerical range, and the drug-loading density in the proximal coating 110 is greater than the drug-loading density in the middle coating 111, The drug loading density in the distal coating 112 is greater than that in the middle coating 111 .
具体的，药物涂层11中，药物涂层11的厚度为1-100um，优选为2-50um，最优选为5-20um。Specifically, in the drug coating 11, the thickness of the drug coating 11 is 1-100 um, preferably 2-50 um, most preferably 5-20 um.
上述药物球囊1，具体可以通过下述方式制备。将药物113和赋形剂114与四氢呋喃进行混合，得到混合液。首先通过喷涂的方式将混合液均匀涂覆在球囊10的表面，经过风干获得载药密度均匀的药物涂层。随后，在均匀的近端涂层110和远端涂层112表面再喷涂一层混合溶液，经过风干获得近端涂层110中的载药密度大于中段涂层111中的载药密度，远端涂层112中的载药密度大于中段涂层111中的载药密度的药物球囊1。最后将药物球囊1进行折叠压握，轮廓状态呈三翼。The above drug balloon 1 can be specifically prepared in the following manner. The drug 113 and the excipient 114 are mixed with tetrahydrofuran to obtain a mixed solution. Firstly, the mixed solution is evenly coated on the surface of the balloon 10 by spraying, and then air-dried to obtain a drug coating with uniform drug loading density. Subsequently, spray a layer of mixed solution on the surface of the uniform near-end coating 110 and the far-end coating 112, and obtain the drug-loading density in the near-end coating 110 greater than the drug-loading density in the middle coating 111 through air-drying, and the far-end The drug balloon 1 in which the drug-loaded density in the coating 112 is greater than the drug-loaded density in the middle coating 111 . Finally, the drug balloon 1 is folded and pressed, and the contour state is three-winged.
请参考图4(a)，为支架内再狭窄病变2的结构示意图。植入的支架23造成的支架内再狭窄病变2包括：支架内再狭窄病变近端20、支架内再狭窄病变中段21和支架内再狭窄病变远端22。其中，再狭窄病变近端20和再狭窄病变远端22的平滑肌细胞增生更严重，管腔通畅率更低，狭窄程度更大。Please refer to FIG. 4( a ), which is a schematic structural diagram of an in-stent restenosis lesion 2 . The in-stent restenosis lesion 2 caused by the implanted stent 23 includes: the proximal end 20 of the in-stent restenosis lesion, the middle section 21 of the in-stent restenosis lesion, and the distal end 22 of the in-stent restenosis lesion. Among them, the proliferation of smooth muscle cells in the proximal 20 and distal 22 restenotic lesions is more serious, the lumen patency rate is lower, and the degree of stenosis is greater.
请参考图5(a)，为收缩状态下的药物球囊1被输送到支架内再狭窄病变2内的结构示意图。在目标部位，确保收缩状态下，近端涂层110与再狭窄病变近端20对应，中段涂层111与再狭窄病变中段21对应，远端涂层112与再狭窄病变远端22对应。Please refer to FIG. 5( a ), which is a schematic structural diagram of the drug balloon 1 being delivered into the in-stent restenosis lesion 2 in a deflated state. At the target site, under contraction state, the proximal coating 110 corresponds to the proximal end 20 of the restenotic lesion, the middle coating 111 corresponds to the middle section 21 of the restenotic lesion, and the distal coating 112 corresponds to the distal end 22 of the restenotic lesion.
请参考图6(a)，为对药物球囊1充压，使其支撑起支架内再狭窄病变2的结构示意图。对药物球囊1充压时，近端涂层110对病变近端20进行扩张时释放的药物113的量更大，具有更强的抑制平滑肌细胞增生的作用。支撑并释放药物完成后，对药物球囊1泄压，将其撤出体外。Please refer to FIG. 6( a ), which is a structural schematic view of inflating a drug balloon 1 to support an in-stent restenosis lesion 2 . When the drug balloon 1 is inflated, the amount of the drug 113 released when the proximal coating 110 expands the proximal lesion 20 is larger, and has a stronger effect of inhibiting smooth muscle cell proliferation. After supporting and releasing the medicine, the medicine balloon 1 is depressurized and withdrawn from the body.
实施例(二)Embodiment (2)
请参考图1(b)，2(b)和图3。图1(b)为本发明实施例二中药物球囊1的结构示意图；图2(b)为药物涂层11的结构示意图；图3为药物球囊1的横截面的结构示意图。该实施例中，药物球囊1包括球囊10和药物涂层11。Please refer to Figure 1(b), 2(b) and Figure 3. Figure 1(b) is a schematic structural view of the drug balloon 1 in Example 2 of the present invention; Figure 2(b) is a schematic structural view of the drug coating 11; Figure 3 is a schematic structural view of the cross section of the drug balloon 1. In this embodiment, the drug balloon 1 includes a balloon 10 and a drug coating 11 .
其中，药物涂层11位于球囊表面，包括近端涂层110、中段涂层111和远端涂层112，且近端涂层110、中段涂层111和远端涂层112顺序排布连接。药物涂层11包括药物113和赋形剂114。近端涂层110中的载药密度大于中段涂层中111的载药密度，远端涂层112中的载药密度等于中段涂层111中的载药密度。在其他实施例中，近端涂层110、中段涂层111和远端涂层112也可以呈不连接的间断式结构。Wherein, the drug coating 11 is located on the surface of the balloon, including a proximal coating 110, a middle coating 111 and a distal coating 112, and the proximal coating 110, the middle coating 111 and the distal coating 112 are sequentially arranged and connected . Drug coating 11 includes drug 113 and excipient 114 . The drug loading density in the proximal coating 110 is greater than that in the middle coating 111 , and the drug loading density in the distal coating 112 is equal to the drug loading density in the middle coating 111 . In other embodiments, the near-end coating 110 , the middle-section coating 111 and the distal coating 112 may also be in an intermittent structure that is not connected.
具体的，球囊10采用尼龙材料。根据需要，球囊也可以采用改性尼龙、尼龙弹性体和线形低密度聚乙烯几种材料中的一种或几种。Specifically, the balloon 10 is made of nylon material. According to needs, the balloon can also use one or more of several materials including modified nylon, nylon elastomer and linear low-density polyethylene.
具体的，药物涂层11中，药物113为紫杉醇。根据需要，药物也可以为多烯紫杉醇、雷帕霉素及其衍生物、他汀类药物、阿司匹林、华法林、肝素、低分子肝素和西洛它唑中的一种或几种。Specifically, in the drug coating 11, the drug 113 is paclitaxel. According to needs, the drug can also be one or more of docetaxel, rapamycin and its derivatives, statins, aspirin, warfarin, heparin, low molecular weight heparin and cilostazol.
具体的，药物涂层11中，赋形剂114为聚乙二醇。根据需要，赋形剂也可以为碘海醇、硬脂酸镁、碘普罗胺、尿素、聚山梨酯、山梨糖醇、丁酰基三己基柠檬酸酯、乙酰基柠檬酸三丁酯、有机酯、虫胶和月桂酸中的一种或几种。Specifically, in the drug coating 11, the excipient 114 is polyethylene glycol. As required, excipients can also be iohexol, magnesium stearate, iopromide, urea, polysorbate, sorbitol, butyryl trihexyl citrate, acetyl tributyl citrate, organic esters One or more of , shellac and lauric acid.
具体的，药物涂层11中，药物涂层11的载药密度为0.1-9.0ug/mm2，优选为0.5-5.0ug/mm2，最优选为2.0-4.0ug/mm2。Specifically, in the drug coating 11, the drug loading density of the drug coating 11 is 0.1-9.0 ug/mm2 , preferably 0.5-5.0 ug/mm2 , most preferably 2.0-4.0 ug/mm2 .
具体的，药物涂层11中，药物涂层11的厚度为1-100um，优选为2-50um，最优选为5-20um。Specifically, in the drug coating 11, the thickness of the drug coating 11 is 1-100 um, preferably 2-50 um, most preferably 5-20 um.
上述药物球囊1，具体可以通过下述方式制备。将药物113和赋形剂114与四氢呋喃进行混合，得到药物含量不同的两种混合液。首先通过喷涂的方式将低浓度混合液均匀涂覆在球囊10的中段和远端表面，获得中段涂层111和远端涂层112。随后，通过喷涂的方式将高药物浓度混合液均匀涂覆在球囊10的近端表面，获得近端涂层110。接下来，将药物球囊1进行风干处理，获得近端涂层110中的载药密度大于中段涂层111中的载药密度等于远端涂层112种的载药密度的药物球囊1。最后将药物球囊1进行折叠压握，轮廓状态呈六翼。The above drug balloon 1 can be specifically prepared in the following manner. The drug 113 and the excipient 114 are mixed with tetrahydrofuran to obtain two mixed solutions with different drug contents. Firstly, the low-concentration mixed solution is evenly coated on the middle section and the distal surface of the balloon 10 by spraying, so as to obtain the middle section coating 111 and the distal end coating 112 . Subsequently, the mixture solution with high drug concentration is evenly coated on the proximal surface of the balloon 10 by spraying to obtain the proximal coating 110 . Next, the drug balloon 1 is air-dried to obtain a drug balloon 1 whose drug-loading density in the proximal coating 110 is greater than that in the middle coating 111 and equal to the drug-loading density of the distal coating 112 . Finally, the drug balloon 1 is folded and pressed, and the contour state is six-winged.
请参考图4(b)，为支架内再狭窄病变2的结构示意图。植入的支架23造成的支架内再狭窄病变2包括：支架内再狭窄病变近端20、支架内再狭窄病变中段21和支架内再狭窄病变远端22。其中，再狭窄病变近端20的平滑肌细胞增生更严重，管腔通畅率更低，狭窄程度更大。Please refer to FIG. 4( b ), which is a schematic structural diagram of an in-stent restenosis lesion 2 . The in-stent restenosis lesion 2 caused by the implanted stent 23 includes: the proximal end 20 of the in-stent restenosis lesion, the middle section 21 of the in-stent restenosis lesion, and the distal end 22 of the in-stent restenosis lesion. Among them, the proliferation of smooth muscle cells in the proximal 20 of the restenotic lesion was more serious, the lumen patency rate was lower, and the degree of stenosis was greater.
请参考图5(b)，为收缩状态下的药物球囊1被输送到支架内再狭窄病变2内的结构示意图。在目标部位，确保收缩状态下，近端涂层110与再狭窄病变近端20对应，中段涂层111与再狭窄病变中段21对应，远端涂层112与再狭窄病变远端22对应。Please refer to FIG. 5( b ), which is a schematic structural diagram of the drug balloon 1 being delivered into the in-stent restenosis lesion 2 in a deflated state. At the target site, under contraction state, the proximal coating 110 corresponds to the proximal end 20 of the restenotic lesion, the middle coating 111 corresponds to the middle section 21 of the restenotic lesion, and the distal coating 112 corresponds to the distal end 22 of the restenotic lesion.
请参考图6(b)，为对药物球囊1充压，使其支撑起支架内再狭窄病变2的结构示意图。对药物球囊1充压时，近端涂层110对病变近端20进行扩张时释放的药物113的量更大，具有更强的抑制平滑肌细胞增生的作用。支撑并释放药物完成后，对药物球囊1泄压，将其撤出体外。Please refer to FIG. 6( b ), which is a schematic structural diagram of inflating a drug balloon 1 to support an in-stent restenosis lesion 2 . When the drug balloon 1 is inflated, the amount of the drug 113 released when the proximal coating 110 expands the proximal lesion 20 is larger, and has a stronger effect of inhibiting smooth muscle cell proliferation. After supporting and releasing the medicine, the medicine balloon 1 is depressurized and withdrawn from the body.
在上述各实施例中，球囊包括顺次连接的球囊近端部、球囊中段部和球囊远端部，球囊包括顺次连接的球囊近端部、球囊中段部和球囊远端部，近端涂层位于球囊近端部表面、中段涂层位于球囊中段部表面、远端涂层位于球囊远端部表面，且充压状态下，球囊近端部与球囊远端部中一者的直径大于球囊中段部的直径，另一者的直径不小于所述球囊中段部的直径。也就是既包括球囊近端部和球囊远端部的直径均大于球囊中段部的直径，且二者的直径相等；在其他实施中，也包括球囊近端部和球囊远端部的直径均大于球囊中段部的直径，但二者的直径不相等；还包括球囊近端部的直径大于球囊中段部的直径，球囊远端部的直径等于球囊中段部的直径，或者球囊近端部的直径等于球囊中段部的直径，球囊远端部的直径大于球囊中段部的直径，进而能够适用于支架内再狭窄病变两端平滑肌细胞增生程度不同的情况。根据球囊近端部、球囊中段部和球囊远端部形状的不同，若球囊近端部、球囊中段部或球囊远端部的直径有变化，则球囊近端部和球囊远端部的最大直径大于球囊中段部的最大直径。优选的，球囊近端部、球囊中段部和球囊远端部之间平滑过渡连接。In each of the above embodiments, the balloon comprises a balloon proximal part, a balloon midsection and a balloon distal part which are sequentially connected, and the balloon comprises a sequentially connected balloon proximal part, a balloon midsection and a balloon The distal part of the balloon, the proximal coating is located on the surface of the proximal part of the balloon, the middle coating is located on the surface of the middle part of the balloon, and the distal coating is located on the surface of the distal part of the balloon. The diameter of one of the distal end of the balloon is larger than the diameter of the middle section of the balloon, and the diameter of the other is not smaller than the diameter of the middle section of the balloon. That is to say, both the diameters of the proximal end of the balloon and the distal end of the balloon are larger than the diameter of the middle section of the balloon, and the diameters of the two are equal; in other implementations, the proximal end of the balloon and the distal end of the balloon are also included. The diameters of both parts are larger than the diameter of the middle part of the balloon, but the diameters of the two are not equal; the diameter of the proximal part of the balloon is larger than the diameter of the middle part of the balloon, and the diameter of the distal part of the balloon is equal to that of the middle part of the balloon. diameter, or the diameter of the proximal part of the balloon is equal to the diameter of the middle part of the balloon, and the diameter of the distal part of the balloon is larger than the diameter of the middle part of the balloon, so that it can be applied to patients with different degrees of smooth muscle cell proliferation at both ends of in-stent restenosis lesions Happening. According to the difference in the shape of the proximal part of the balloon, the middle part of the balloon and the distal part of the balloon, if the diameter of the proximal part of the balloon, the middle part of the balloon or the distal part of the balloon changes, the proximal part of the balloon and the diameter of the distal part of the balloon change. The maximum diameter of the distal portion of the balloon is greater than the maximum diameter of the mid-section of the balloon. Preferably, there is a smooth transition connection between the proximal end of the balloon, the middle section of the balloon and the distal end of the balloon.
支架内再狭窄病变中，支架近端和/或远端部分的血管平滑肌细胞增生最为严重，来自血管的径向载荷最大。本发明提供的药物球囊，近端涂层与远端涂层中一者的载药密度大于中段涂层的载药密度，另一者的载药密度不小于中段涂层的载药密度。对于对应的设置充压状态下，球囊近端部与球囊远端部中一者的直径大于球囊中段部的直径，另一者的直径不小于所述球囊中段部的直径。例如：在近端涂层的载药密度大于中段涂层的载药密度，远端涂层的载药密度不小于中段涂层的载药密度时，球囊近端部的直径大于球囊中段部的直径，球囊远端部的直径不小于球囊中段部的直径。进而一方面能够对重点区域选择性给药，保证支架近端和/或远端的严重病变处的药物含量相对更高。另一方面，充压状态下，球囊对近端或远端严重狭窄处的支撑作用更加强劲，具有更强的抑制平滑肌细胞增生的作用。In stent restenosis lesions, the proliferation of vascular smooth muscle cells in the proximal and/or distal parts of the stent is the most serious, and the radial load from the blood vessel is the largest. In the drug balloon provided by the present invention, the drug-loading density of one of the proximal coating and the distal coating is greater than that of the middle coating, and the drug-loading density of the other is not less than that of the middle coating. For a corresponding setting and inflated state, the diameter of one of the proximal end and the distal end of the balloon is larger than the diameter of the middle section of the balloon, and the diameter of the other is not smaller than the diameter of the middle section of the balloon. For example: when the drug-loading density of the proximal coating is greater than that of the middle coating, and the drug-loading density of the distal coating is not less than that of the middle coating, the diameter of the proximal portion of the balloon is greater than that of the middle portion of the balloon. The diameter of the distal end of the balloon is not smaller than the diameter of the middle section of the balloon. Furthermore, on the one hand, it can selectively administer drugs to key areas to ensure that the drug content in severe lesions at the proximal end and/or distal end of the stent is relatively higher. On the other hand, under the inflated state, the balloon has a stronger support effect on the proximal or distal severe stenosis, and has a stronger effect of inhibiting the proliferation of smooth muscle cells.
具体的，球囊近端部包括顺次连接的球囊近端部近端、球囊近端部中段和球囊近端部远端，球囊近端部近端的直径由远离球囊近端部中段的一端向另一端逐渐增大。球囊近端部近端的直径由远离球囊近端部中段的一端向另一端(也就是靠近球囊近端部中段的一端)逐渐增大，优选的，逐渐增大至与球囊近端部中段的直径相等。也就是球囊近端部的端部直径是过渡的，从而便于介入球囊的移动。Specifically, the proximal end of the balloon includes the proximal end of the proximal end of the balloon, the middle section of the proximal end of the balloon, and the distal end of the proximal end of the balloon. One end of the middle section of the end gradually increases toward the other end. The diameter of the proximal end of the proximal end of the balloon gradually increases from one end far away from the middle section of the proximal end of the balloon to the other end (that is, the end near the middle section of the proximal end of the balloon), preferably, gradually increases to the diameter close to the balloon. The diameters of the end midsections are equal. That is, the end diameter of the proximal end of the balloon is transitional, thereby facilitating the movement of the interventional balloon.
进一步地，球囊近端部近端的轮廓呈斜直线形、正余弦线形、双曲线形、指数线形或对数线形中的一种；球囊近端部中段呈圆柱形或圆锥形；球囊近端部远端的轮廓呈水平线形、斜直线形、正余弦线形、双曲线形、指数线形或对数线形中的一种。Further, the contour of the proximal end of the proximal end of the balloon is one of oblique linear, sinusoidal, hyperbolic, exponential or logarithmic; the middle section of the proximal end of the balloon is cylindrical or conical; The contour of the distal end of the proximal end of the capsule is one of horizontal linear, oblique linear, sinusoidal, hyperbolic, exponential or logarithmic linear.
更进一步地，球囊中段部呈圆柱形或圆锥形。Furthermore, the middle section of the balloon is cylindrical or conical.
具体的，球囊远端部包括顺次连接的球囊远端部近端、球囊远端部中段和球囊远端部远端，球囊远端部远端的直径由远离球囊远端部中段的一端向另一端逐渐增大。也就是球囊远端部12的端部直径是过渡的，从而便于介入球囊的移动。Specifically, the distal end of the balloon includes the proximal end of the distal end of the balloon, the middle section of the distal end of the balloon, and the distal end of the distal end of the balloon. One end of the middle section of the end gradually increases toward the other end. That is, the end diameter of the distal end portion 12 of the balloon is transitional, so as to facilitate the movement of the interventional balloon.
进一步地，球囊远端部近端轮廓呈水平线形、斜直线形、正余弦线形、双曲线形、指数线形或对数线形中的一种；球囊远端部中段呈圆柱形或圆锥形；球囊远端部远端轮廓呈斜直线形、正余弦线形、双曲线形、指数线形或对数线形中的一种。Further, the proximal contour of the distal end of the balloon is one of horizontal linear, oblique linear, sinusoidal, hyperbolic, exponential or logarithmic linear; the middle section of the distal end of the balloon is cylindrical or conical ; The distal contour of the distal end of the balloon is one of oblique linear shape, sinusoidal linear shape, hyperbolic shape, exponential linear shape or logarithmic linear shape.
综上，在本发明所提供治疗支架内再狭窄的药物球囊1包括球囊10和位于球囊表面的药物涂层11，药物涂层11包括近端涂层110、中段涂层111和远端涂层112，所有药物涂层11包括药物113和赋形剂114，近端涂层110与远端涂层112中一者的载药密度大于中段涂层111中的载药密度，另一者的载药密度不小于中段涂层111的载药密度。In summary, the drug balloon 1 for treating in-stent restenosis provided by the present invention includes a balloon 10 and a drug coating 11 on the surface of the balloon. The drug coating 11 includes a proximal coating 110, a middle coating 111 and a distal End coating 112, all drug coatings 11 include medicines 113 and excipients 114, the drug loading density of one of the proximal coating 110 and the distal coating 112 is greater than the drug loading density in the middle coating 111, the other The drug-loading density of those is not less than the drug-loading density of the middle coating 111.
本申请的技术方案通过对药物球囊的结构、加工和使用方法设计，根据影像学反馈，判断严重再狭窄发生在病变近端或远端中的一处或两处，选择本发明中的药物球囊进行充压，对重点区域选择性给药，保证支架近端和/或远端的严重病变处的药物含量相对更高，更有效地抑制平滑肌细胞过度增生，提高远期管腔通畅率，保证治疗效果，同时降低整段病变的药物总含量，进而减小机体药物毒性和不良反应。The technical solution of the present application designs the structure, processing and use method of the drug balloon, and according to imaging feedback, it is judged that severe restenosis occurs at one or two of the proximal end or the distal end of the lesion, and the drug in the present invention is selected. The balloon is inflated, and the drug is selectively administered to key areas to ensure that the drug content in the severe lesions at the proximal end and/or distal end of the stent is relatively higher, which can more effectively inhibit the excessive proliferation of smooth muscle cells and improve the long-term lumen patency rate , to ensure the therapeutic effect, and at the same time reduce the total drug content of the entire lesion, thereby reducing drug toxicity and adverse reactions in the body.
本说明书中各个实施例采用递进的方式描述，每个实施例重点说明的都是与其他实施例的不同之处，各个实施例之间相同相似部分互相参见即可。Each embodiment in this specification is described in a progressive manner, each embodiment focuses on the difference from other embodiments, and the same and similar parts of each embodiment can be referred to each other.
对所公开的实施例的上述说明，使本领域专业技术人员能够实现或使用本发明。对这些实施例的多种修改对本领域的专业技术人员来说将是显而易见的，本文中所定义的一般原理可以在不脱离本发明的精神或范围的情况下，在其它实施例中实现。因此，本发明将不会被限制于本文所示的这些实施例，而是要符合与本文所公开的原理和新颖特点相一致的最宽的范围。The above description of the disclosed embodiments is provided to enable any person skilled in the art to make or use the invention. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the general principles defined herein may be implemented in other embodiments without departing from the spirit or scope of the invention. Therefore, the present invention will not be limited to the embodiments shown herein, but is to be accorded the widest scope consistent with the principles and novel features disclosed herein.
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201810399893.XACN108378964A (en) | 2018-04-28 | 2018-04-28 | A kind of medicinal balloon |
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201810399893.XACN108378964A (en) | 2018-04-28 | 2018-04-28 | A kind of medicinal balloon |
| Publication Number | Publication Date |
|---|---|
| CN108378964Atrue CN108378964A (en) | 2018-08-10 |
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201810399893.XAPendingCN108378964A (en) | 2018-04-28 | 2018-04-28 | A kind of medicinal balloon |
| Country | Link |
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| CN (1) | CN108378964A (en) |
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| CN111701081A (en)* | 2020-06-23 | 2020-09-25 | 首都医科大学 | A kind of drug coating liquid for drug coating balloon, drug coating balloon |
| CN116370803A (en)* | 2023-03-20 | 2023-07-04 | 北京先瑞达医疗科技有限公司 | Drug coating conveying device |
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| Date | Code | Title | Description |
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| PB01 | Publication | ||
| PB01 | Publication | ||
| SE01 | Entry into force of request for substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| RJ01 | Rejection of invention patent application after publication | Application publication date:20180810 | |
| RJ01 | Rejection of invention patent application after publication |