CN210078552U - Delivery and application system for local anesthesia sustained-release drug-coated stents - Google Patents
Delivery and application system for local anesthesia sustained-release drug-coated stents Download PDFInfo
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Abstract
Description
技术领域technical field
本实用新型涉及医疗器械领域,具体而言,涉及一种局麻缓释药物涂层支架的输送敷贴系统。The utility model relates to the field of medical devices, in particular to a delivery and application system for a local anesthesia sustained-release drug-coated stent.
背景技术Background technique
超范围外科切除术仍然是腔道肿瘤(管腔癌,胆管癌,肠道内肿瘤,气管内肿瘤,血管内癌栓,输尿管癌等)的唯一根治性方法。但大部分患者就诊时已经发生局部浸润及远隔脏器的转移。对于此类患者,提高生活质量延长生存期成为主要的治疗目标。比如腔道内植入金属支架开通狭窄管腔以姑息性缓解患者临床症状,植入的金属支架往往需要超过肿瘤组织两端至少2cm以上。支架物理性膨胀将肿瘤组织挤压至管壁外侧。金属支架的持续膨胀导致部分患者出现局部不适症状,比如气管支架导致患者持续的咳嗽,尤其是夜间无法入眠,严重影响生活质量。高位管腔支架导致患者出现严重的异物感,肠道支架导致患者出现严重的腹痛,输尿管支架导致患者出现腰骶部严重的不适感。局麻药物(比如布比卡因/利多卡呀)的使用能明显降低患者的局部不适提高生活质量。采用现代化的涂膜载药技术,比如PGLA,纳米涂层,石墨烯等作为载体,将局部药物载支架的外膜中,释放金属支架后,通过局麻药物的缓慢释放来降低支架植入压迫肿瘤所引起的相关不适等症状,由于药物为局部持续低剂量释放,因此不会引起药物蓄积等相关并发症,值得临床进一步推广。Surgical resection is still the only radical approach for luminal tumors (luminal cancer, cholangiocarcinoma, intestinal tumor, intratracheal tumor, intravascular tumor thrombus, ureteral cancer, etc.). However, local infiltration and metastasis of distant organs have already occurred in most patients. For such patients, improving the quality of life and prolonging the survival period has become the main treatment goal. For example, metal stents are implanted in the lumen to open the narrow lumen to palliatively relieve the clinical symptoms of patients. The implanted metal stents often need to exceed the two ends of the tumor tissue by at least 2 cm. The physical expansion of the stent pushes the tumor tissue to the outside of the tube wall. The continuous expansion of metal stents leads to local discomfort in some patients. For example, tracheal stents cause continuous coughing, especially at night, which seriously affects the quality of life. The high-level luminal stent causes severe foreign body sensation in the patient, the intestinal stent causes the patient to experience severe abdominal pain, and the ureteral stent causes the patient to experience severe discomfort in the lumbosacral region. The use of local anesthetics (such as bupivacaine/lidoca) can significantly reduce the local discomfort of patients and improve the quality of life. Using modern coating drug-loading technology, such as PGLA, nano-coating, graphene, etc. as the carrier, the outer membrane of the local drug-carrying stent is released. After the metal stent is released, the local anesthetic drug is slowly released to reduce the stent implantation compression For symptoms such as related discomfort caused by tumors, because the drug is locally and continuously released in low doses, it will not cause related complications such as drug accumulation, which is worthy of further clinical promotion.
除此之外,肝癌也是临床上常见的恶性肿瘤,肝癌的患者常常因肿瘤侵犯门静脉而形成门静脉癌栓导致疾病迅速进展,远期生存极差。因此门静脉癌栓的处理对肝癌患者的远期生存具有决定性意义作用。临床上常常采用外放疗治疗门静脉癌栓,但由于癌栓波及范围广,且沿着弯曲的血管系统分布导致定位放疗困难,且由于呼吸运动导致患者肝脏运动,为了覆盖肿瘤范围需要扩大外放疗照射范围进而对肝脏造成较大损伤。临床上姑息性治疗方案主要围绕开通门静脉管腔,恢复入肝血流,进而提高患者生活质量。需要采用介入微创穿刺技术,植入门静脉支架开通血管,但支架仅能开通管腔,对肿瘤无治疗作用,伴随着肿瘤的进展,3个月内超过50%以上的患者会发生支架内再堵塞发生。因此国内有学者采用近距离放射性粒子串成链状结构,并使用介入技术将125I粒子链压在支架外,通过粒子的近距离放射治疗控制部分癌栓,从而延长支架的通畅时间。但由于植入的粒子链具有随机性,经常粒子链植入到了非肿瘤一次导致近距离放疗失败。而且临床研究表明,使用粒子链仅能延长2-3月的通畅时间。分析原因如下:粒子的数量少,导致剂量冷区过多;粒子链位于肿瘤组织对侧,加上支架膨胀后,粒子距离肿瘤更远,无法发挥更好的抗肿瘤作用。因此,迫切需要研发一整套螺旋状125I粒子植入系统,一方面解决剂量分布不均的问题,减少剂量冷区。一方面,能够使得肿瘤与粒子充分接触,提高近距离放疗疗效。In addition, liver cancer is also a common clinical malignant tumor. Patients with liver cancer often form portal vein tumor thrombus due to tumor invasion of the portal vein, resulting in rapid disease progression and poor long-term survival. Therefore, the treatment of portal vein tumor thrombus plays a decisive role in the long-term survival of patients with liver cancer. External radiotherapy is often used clinically to treat portal vein tumor thrombi. However, due to the wide spread of tumor thrombus and its distribution along the tortuous vascular system, it is difficult to locate radiotherapy, and the patient’s liver moves due to breathing motion. In order to cover the tumor, it is necessary to expand external radiotherapy exposure. range and cause greater damage to the liver. Clinically, the palliative treatment plan mainly focuses on opening the portal vein lumen to restore the blood flow into the liver, thereby improving the quality of life of patients. It is necessary to use minimally invasive puncture techniques to implant portal vein stents to open blood vessels, but the stents can only open the lumen and have no therapeutic effect on the tumor. With the progress of the tumor, more than 50% of patients will have intra-stent resection within 3 months. Blockage occurs. Therefore, some domestic scholars use the short-range radioactive particles to form a chain structure, and use the interventional technology to press the 125I particle chain outside the stent, and control part of the tumor thrombus through the brachytherapy of the particles, thereby prolonging the patency time of the stent. However, due to the randomness of the implanted particle chains, often the particle chains are implanted into a non-tumor once, resulting in failure of brachytherapy. And clinical studies have shown that the use of particle chains can only prolong the patency time of 2-3 months. The reasons for the analysis are as follows: the number of particles is small, resulting in excessive dose cold zone; the particle chain is located on the opposite side of the tumor tissue, and after the stent is expanded, the particles are farther away from the tumor and cannot exert a better anti-tumor effect. Therefore, it is urgent to develop a complete set of helical 125I seed implantation system, on the one hand, to solve the problem of uneven dose distribution and reduce the dose cold zone. On the one hand, the tumor can be fully contacted with the particles, and the curative effect of brachytherapy can be improved.
发明内容SUMMARY OF THE INVENTION
为解决上述问题,本实用新型的目的在于提供一种局麻缓释药物涂层支架的输送敷贴系统,其通过导管机构内第二套管和第三套管的伸长,将套于其间的覆膜层拉开贴在支架上,利用覆膜层上的药物敷贴层上缓释麻醉剂进行麻醉和粒子仓层内的放射粒子进行放射治疗,无需进行取出原有支架并更换碘125粒子支架,不会造成二次伤害。In order to solve the above-mentioned problems, the purpose of this utility model is to provide a delivery and application system for a local anesthesia sustained-release drug-coated stent, which, through the elongation of the second cannula and the third cannula in the catheter mechanism, will be sleeved therebetween. The coating layer is pulled and attached to the stent, and the sustained-release anesthetic on the drug application layer on the coating layer is used for anesthesia and the radioactive particles in the particle chamber layer for radiotherapy without removing the original stent and replacing the iodine 125 particles. The bracket will not cause secondary damage.
本实用新型的目的是通过以下技术方案实现的:The purpose of this utility model is to realize through the following technical solutions:
本实用新型提供的一种局麻缓释药物涂层支架的输送敷贴系统,其中,包括用于紧贴在支架的覆膜层及用于将所述覆膜层输送至管腔内紧贴在支架的导管机构;所述覆膜层上均匀分布设置有用于附着固态的缓释麻醉剂的药物敷贴层和用于装载放射粒子的粒子仓层;所述导管机构包括第一套管、套接在所述第一套管内的第二套管及套接在所述第二套管内的第三套管,所述第三套管内贯穿有导丝,所述覆膜层套设在所述第一套管内且处于所述第二套管与所述第三套管之间,所述第三套管从所述第二套管伸出后将所述覆膜层拉开贴在支架上。The utility model provides a delivery and application system for a local anesthesia sustained-release drug-coated stent, which comprises a film covering layer for tightly adhering to the stent and a film covering layer used for transporting the film covering layer into the lumen to be closely adhered In the catheter mechanism of the stent; the coating layer is evenly distributed with a drug application layer for attaching solid sustained-release anesthetics and a particle warehouse layer for loading radioactive particles; the catheter mechanism includes a first sleeve, a sleeve A second sleeve connected to the first sleeve and a third sleeve sleeved to the second sleeve, a guide wire is inserted through the third sleeve, and the coating layer is sleeved on the second sleeve. Inside the first sleeve and between the second sleeve and the third sleeve, after the third sleeve protrudes from the second sleeve, the coating layer is pulled apart and attached to the stent .
作为本实用新型的一种改进,所述第一套管内设置有收拢腔,所述第二套管的下端外壁上连接有上层球囊,所述第三套管的下端外壁上连接有下层球囊,所述收拢腔可收拢所述上层球囊和下层球囊;所述第一套管内设置有第一气道,所述第一气道内设置有第一充气管,所述上层球囊通过所述第一充气管与第一充气单向阀接头连通;所述第三套管内设置有第二气道,所述第二气道内设置有第二充气管,所述下层球囊通过所述第二充气管与第二充气单向阀接头连通。As an improvement of the present invention, the first sleeve is provided with a retraction cavity, the outer wall of the lower end of the second sleeve is connected with an upper layer balloon, and the outer wall of the lower end of the third sleeve is connected with a lower layer balloon The upper layer balloon and the lower layer balloon can be folded in the retracting cavity; a first airway is arranged in the first sleeve, a first inflation tube is arranged in the first airway, and the upper layer balloon passes through The first inflatable tube is communicated with the first inflatable one-way valve joint; the third sleeve is provided with a second airway, the second airway is provided with a second inflatable tube, and the lower-layer balloon passes through the The second inflation tube communicates with the second inflation check valve joint.
作为本实用新型的进一步改进,所述上层球囊与所述下层球囊均设置有两个球囊腔。As a further improvement of the present invention, both the upper-layer balloon and the lower-layer balloon are provided with two balloon cavities.
作为本实用新型的更进一步改进,所述覆膜层的上下两端均设置有卡圈,所述卡圈上设置有用于卡在支架上的支架夹紧槽。As a further improvement of the present invention, the upper and lower ends of the coating layer are provided with clamp rings, and the clamp rings are provided with bracket clamping grooves for being clamped on the support.
作为本实用新型的更进一步改进,所述卡圈上设置有两个用于储存缓释麻醉剂的缓释麻醉药腔,所述缓释麻醉药腔上设置有卡圈渗透孔。As a further improvement of the present utility model, two sustained-release anesthetic chambers for storing sustained-release anesthetics are provided on the collar, and a collar penetration hole is provided on the sustained-release anesthetic chambers.
作为本实用新型的更进一步改进,两个所述缓释麻醉药腔通过连通槽相通。As a further improvement of the present invention, the two sustained-release anesthetic chambers are communicated through a communication groove.
作为本实用新型的更进一步改进,所述卡圈上设置有斜面,所述上层球囊与所述下层球囊的外圈设置有与所述斜面吻合的让位槽面。As a further improvement of the present invention, the collar is provided with an inclined surface, and the outer rings of the upper-layer balloon and the lower-layer balloon are provided with a receding groove surface matching the inclined surface.
作为本实用新型的更进一步改进,所述药物敷贴层上设置有若干个覆膜渗透孔。As a further improvement of the present invention, the drug application layer is provided with a plurality of membrane permeable holes.
作为本实用新型的更进一步改进,所述第一套管内设置有螺旋收拢管,所述第三套管的下端设置有导管头,所述导管头上同轴连接有束紧套,所述第二套管与所述束紧套之间套有夹紧支架,所述螺旋收拢管可套住所述夹紧支架,所述夹紧支架与所述螺旋收拢管之间套住所述覆膜层。As a further improvement of the present invention, the first sleeve is provided with a helical retracting tube, the lower end of the third sleeve is provided with a catheter head, and a tightening sleeve is coaxially connected to the catheter head, and the first sleeve is A clamping bracket is sheathed between the two sleeves and the tightening sleeve, the helical retracting tube can sheath the clamping bracket, and the coating layer is sheathed between the clamping bracket and the spiral retracting tube.
作为本实用新型的更进一步改进,所述第一套管、第二套管与第三套管均设置有手柄端。As a further improvement of the present invention, the first sleeve, the second sleeve and the third sleeve are all provided with handle ends.
在本实用新型中,通过导管机构内第二套管和第三套管的伸长,将套于其间的覆膜层拉开贴在支架上,利用覆膜层上的药物敷贴层上缓释麻醉剂进行麻醉和粒子仓层内的放射粒子进行放射治疗,无需进行取出原有支架并更换碘粒子支架,不会造成二次伤害。In the present utility model, through the extension of the second sleeve and the third sleeve in the catheter mechanism, the film covering between them is pulled apart and attached to the stent, and the drug application layer on the film is used to slow down the Release anesthesia for anesthesia and radioactive particles in the particle compartment layer for radiotherapy without removing the original stent and replacing the iodine particle stent, which will not cause secondary damage.
附图说明Description of drawings
此处所说明的附图用来提供对本实用新型的进一步理解,构成本申请的一部分,本实用新型的示意性实施例及其说明用于解释本实用新型,并不构成对本实用新型的不当限定。在附图中:The accompanying drawings described here are used to provide further understanding of the present invention and constitute a part of the present application. The schematic embodiments and descriptions of the present invention are used to explain the present invention and do not constitute an improper limitation of the present invention. In the attached image:
图1为本实用新型的结构示意图;Fig. 1 is the structural representation of the utility model;
图2为本实用新型的正视图;Fig. 2 is the front view of the utility model;
图3为本实用新型的覆膜层与支架的紧贴结构示意图一;FIG. 3 is a schematic diagram 1 of the close contact structure between the coating layer and the stent of the present invention;
图4为本实用新型的覆膜层与支架的紧贴结构示意图二;FIG. 4 is a second schematic diagram of the close contact structure between the coating layer and the stent of the present invention;
图5为本实用新型的覆膜层的结构示意图一;Fig. 5 is the first structural schematic diagram of the coating layer of the present invention;
图6为本实用新型的卡圈的结构示意图一;Fig. 6 is the structural schematic diagram 1 of the collar of the utility model;
图7为本实用新型的卡圈的结构示意图二;Fig. 7 is the
图8为本实用新型的覆膜层的结构示意图二;8 is a second structural schematic diagram of the coating layer of the present invention;
图9为本实用新型的覆膜层的结构示意图三;Fig. 9 is the structural schematic diagram three of the coating layer of the present invention;
图10为本实用新型的导管机构的内部结构示意图一;10 is a schematic diagram 1 of the internal structure of the catheter mechanism of the present invention;
图11为本实用新型的导管机构的内部结构示意图二;11 is a second schematic diagram of the internal structure of the catheter mechanism of the present invention;
图12为本实用新型的导管机构的内部结构示意图三;12 is a schematic diagram three of the internal structure of the catheter mechanism of the present invention;
图13为本实用新型的导管机构的内部结构示意图四;13 is a schematic diagram 4 of the internal structure of the catheter mechanism of the present invention;
图14为本实用新型的导管机构的内部结构示意图五;14 is a schematic diagram five of the internal structure of the catheter mechanism of the present invention;
图15为本实用新型的上层球囊与卡圈的连接结构示意图;15 is a schematic diagram of the connection structure of the upper layer balloon and the collar of the present invention;
图16为本实用新型的实施例一的结构示意图一;16 is a schematic structural diagram 1 of
图17为本实用新型的实施例一的结构示意图二;17 is a second schematic structural diagram of
图18为本实用新型的实施例一的展开示意图一;FIG. 18 is a schematic diagram 1 of the development of
图19为本实用新型的实施例一的展开示意图二;Fig. 19 is the expanded schematic diagram 2 of
图20为本实用新型的夹紧支架与支架的连接结构示意图;20 is a schematic diagram of the connection structure of the clamping bracket and the bracket of the present invention;
图21为本实用新型的夹紧支架的连接结构示意图一;FIG. 21 is a schematic diagram 1 of the connection structure of the clamping bracket of the present invention;
图22为本实用新型的夹紧支架的连接结构示意图二;Figure 22 is a second schematic diagram of the connection structure of the clamping bracket of the present invention;
图23为本实用新型的夹紧支架的夹紧支架、覆膜层和支架的结构示意图一;Fig. 23 is the first structural schematic diagram of the clamping bracket, the coating layer and the bracket of the clamping bracket of the present invention;
图24为本实用新型的夹紧支架的夹紧支架、覆膜层和支架的结构示意图二;24 is a second structural schematic diagram of the clamping bracket, the coating layer and the bracket of the clamping bracket of the present invention;
图25为本实用新型的夹紧支架的夹紧支架、覆膜层和支架的连接结构爆炸示意图;25 is an exploded schematic diagram of the connection structure of the clamping bracket, the coating layer and the bracket of the clamping bracket of the present invention;
图26为本实用新型的螺旋收拢管的结构示意图一;Figure 26 is the first structural schematic diagram of the spiral retractable tube of the present invention;
图27为本实用新型的螺旋收拢管的结构示意图二;Fig. 27 is the second structural schematic diagram of the helical retracting tube of the present invention;
图28为本实用新型的螺旋收拢管的内部示意图。Fig. 28 is an internal schematic view of the helical retracting tube of the present invention.
其中附图标记为:1-覆膜层,11-药物敷贴层,111-覆膜渗透孔,12-粒子仓层,13-卡圈,131-支架夹紧槽,132-缓释麻醉药腔,133-连通槽,134-斜面,135-卡圈渗透孔,2-导管机构,21-第一套管,211-收拢腔,212-第一气道,213-第一充气管,214-第一充气单向阀接头,215-第二气道,216-第二充气管,217-第二充气单向阀接头,218-螺旋收拢管,22-第二套管,221-上层球囊,222-球囊腔,223-让位槽面,23-第三套管,231-下层球囊,24-导丝,25-手柄端,3-支架。The reference numerals are: 1-coating layer, 11-drug application layer, 111-membrane permeation hole, 12-particle storage layer, 13-clamping ring, 131-support clamping groove, 132-sustained-release anesthetic Cavity, 133-communication groove, 134-bevel, 135-collar penetration hole, 2-catheter mechanism, 21-first sleeve, 211-retraction cavity, 212-first airway, 213-first inflation tube, 214 -The first inflatable one-way valve joint, 215-the second airway, 216-the second inflatable tube, 217-the second inflatable one-way valve joint, 218-spiral retracting tube, 22-the second sleeve, 221-the upper ball Balloon, 222-Balloon cavity, 223-Give way groove surface, 23-Third cannula, 231-Lower balloon, 24-Guide wire, 25-Handle end, 3-Stand.
具体实施方式Detailed ways
为了使本技术领域的人员更好地理解本实用新型方案,下面将结合本实用新型实施例中的附图,对本实用新型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实用新型一部分的实施例,而不是全部的实施例。基于本实用新型中的实施例,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,都应当属于本实用新型保护的范围。In order to enable those skilled in the art to better understand the solutions of the present invention, the technical solutions in the embodiments of the present invention will be described clearly and completely below with reference to the accompanying drawings in the embodiments of the present invention. Obviously, the described The embodiments are only some of the embodiments of the present invention, but not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by persons of ordinary skill in the art without creative work shall fall within the protection scope of the present invention.
如图1至图28所示,本实用新型的一种局麻缓释药物涂层支架的输送敷贴系统,包括用于紧贴在支架3的覆膜层1及用于将覆膜层1输送至管腔内紧贴在支架3的导管机构2。As shown in Fig. 1 to Fig. 28 , a delivery and application system for a local anesthesia sustained-release drug-coated stent of the present invention includes a
如图5所示,覆膜层1上均匀分布设置有用于附着固态的缓释麻醉剂的药物敷贴层11和用于装载放射粒子的粒子仓层12。As shown in FIG. 5 , a
导管机构2包括第一套管21、套接在第一套管21内的第二套管22及套接在第二套管22内的第三套管23,第三套管23内贯穿有导丝24,覆膜层1套设在第一套管21内且处于第二套管22与第三套管23之间,第三套管23从第二套管22伸出后将覆膜层1拉开贴在支架3上。The
在本实用新型中,通过导管机构2内第二套管22和第三套管23的伸长,将套于其间的覆膜层1拉开贴在支架3上,利用覆膜层1上的药物敷贴层11上缓释麻醉剂进行麻醉和粒子仓层12内的放射粒子进行放射治疗,无需进行取出原有支架并更换碘125粒子支架,不会造成二次伤害。In the present invention, through the elongation of the
支架3为原本存在于患者管腔内壁起通道作用,支架3结构采用编织型,支架3的编织型丝网采用镍钛合金材质制成。与支架3长度与圆周吻合的有覆膜层1,覆膜层1为圆筒形张开时可与支架3内侧紧贴,覆膜层1为高分子柔性材质形成。在支架3网孔的覆膜层1上圆周间隔设置有药物敷贴层11与粒子仓层12。药物敷贴层11与粒子仓层12均在支架3网孔的覆膜沿支架外壁轴向若干条圆周螺旋均匀分布。在粒子仓层12内部装载有条形的碘125粒子,在药物敷贴层11内部附着有固态的缓释麻醉剂,缓释麻醉剂呈圆饼状,可以使得表面最大限度贴合于患者管腔壁上进行麻醉。粒子仓层12采用单条螺旋在支架3网孔处螺旋均匀分布,此设计可以使得支架覆膜的药物与碘125粒子可以圆周整体对管腔区域的肿瘤部位进行放射治疗与药物辅助治疗;且在覆膜层1的药物敷贴层11外层设置有若干的覆膜渗透孔111,覆膜渗透孔111有助于对药物的渗透,使得更加方便对管腔区域肿瘤的药物治疗作用。The
如图3、图6和图7所示,覆膜层1的上下两端均设置有卡圈13,卡圈13上设置有用于卡在支架3上的支架夹紧槽131;卡圈13上设置有两个用于储存缓释麻醉剂的缓释麻醉药腔132,缓释麻醉药腔132上设置有卡圈渗透孔135;两个缓释麻醉药腔132通过连通槽133相通;药物敷贴层11上设置有若干个覆膜渗透孔111;具体地讲,在筒状的覆膜层1上下端端口连接有环形的卡圈13,卡圈13为具有弹性变形特性的医用高分子材料制成。卡圈13朝向支架3上下端面的对应端面上圆周设置有环形的支架夹紧槽131,支架夹紧槽131朝向支架3上下端面的朝向面圆周设置有豁口,且支架夹紧槽131夹紧截面超过半圆区域且与支架3的编织网丝粗细吻合,使得支架夹紧槽131可以对支架3上下端口的支架网丝进行卡紧,当覆膜层1上下端的卡圈13对支架3上下端口卡紧后可以将覆膜层1拉紧使其紧贴合于支架3内侧壁;如图6和图7所示,在卡圈13内部的支架夹紧槽131的靠外侧与上侧斜角处分别设计有环形的空腔为缓释麻醉药腔132,缓释麻醉药腔132内部装有缓释麻醉药,在两个环形的缓释麻醉药腔132的外侧壁上圆周均匀开有若干卡圈渗透孔135,卡圈渗透孔135可使内部的缓释麻醉药渗透出至患者管腔壁以起到麻醉效果。在卡圈13斜角内和外侧壁内的两个缓释麻醉药腔135之间设置有间隔,且间隔面上圆周均匀设置有若干连通槽133,便于两个缓释麻醉药腔132内部液态缓释麻醉药液能够相互渗透连通,防止其中一腔药液干涸无法对管腔壁进行麻醉。As shown in FIG. 3 , FIG. 6 and FIG. 7 , the upper and lower ends of the
如图10至图14所示,第一套管21内设置有收拢腔211,第二套管22的下端外壁上连接有上层球囊221,第三套管23的下端外壁上连接有下层球囊231,收拢腔211可收拢上层球囊221和下层球囊231;第一套管21内设置有第一气道212,第一气道212内设置有第一充气管213,上层球囊221通过第一充气管213与第一充气单向阀接头214连通;第三套管21内设置有第二气道215,第二气道215内设置有第二充气管216,下层球囊231通过第二充气管216与第二充气单向阀接头217连通;如图10和图15所示,上层球囊221与下层球囊231均设置有两个球囊腔222;具体地讲,导管机构2最外层为第一套管21,第一套管21下端面沿轴向向上设置有一定深度盲孔的收拢腔211,收拢腔211内部便于收拢上层球囊221与下层球囊231。在第一套管21上端端头处外壁上固定设置有一字型的手柄端25,手柄端25便于手持控制推拉以及防转作用。在第一套管21的轴心处贯通孔处套接有第二套管22,第二套管22上端端头外壁上设置有与第一套管21相同的手柄端25,在第二套管22下端端口处外壁上设置有上层球囊221,上层球囊221膨胀充盈时为圆饼状,上层球囊221内部中间高度处设置有间隔层使其分隔为两个球囊腔222,分别为上层球囊一腔和上层球囊二腔。通过间隔层设置为两个腔的目的在于可以通过间隔层的支撑,使得上层球囊221在充盈后的外圈中间位置具有一定的强度,不会像上层球囊221其他区域在触压后容易凹陷变形。在第一套管21的侧壁内部沿轴向开有第一气道212,第一气道212下端在上层球囊一腔与二腔分别设置有通气孔,在第一套管21上端第一气道212端口处连接有第一充气管213,在第一充气管213端头处连接有第一充气单向阀接头214,通过第一充气单向阀接头214可以对上层气囊221内部两个腔同步进行充气。在第二套管22内部套接有第三套管23,在第三套管23上端端头侧壁上同样设置有一字型手柄端25,在第三套管23下端端头外壁设置有下层球囊231,下层球囊231结构与上层球囊221相同,下层球囊231同样通过中间的间隔层分为两个腔,且当下层球囊231膨胀充盈后外圈圆周让位槽面223同样可以卡在下方的卡圈13斜面134处。第一套管21下端的收拢腔211具有一定长度可以将上层球囊221、覆膜层1相关结构、下层球囊231依次收支其中。在第三套管23管壁内部轴向设置有第二气道215,第二气道215在下层球囊231两个腔的管壁处开有小孔作为通气孔,在第三套管23的上端连接有第二充气管216与第二充气单向阀接头217用于对下层球囊231进行充气。在第三套管23轴心处内部贯穿有导丝24,用于在导管在体内推进的时候起到引导作用。As shown in FIG. 10 to FIG. 14 , a
在本实用新型中,卡圈13上设置有斜面134,上层球囊221与下层球囊231的外圈设置有与斜面134吻合的让位槽面223;具体地讲,在卡圈13与支架3端口远离的端面角度设置为斜面134,且外侧长内侧短使得斜面134为外侧向内侧倾斜。在上层球囊221圆周外圈设计为与卡圈13斜面134吻合的让位槽面223,使得上层球囊221在充盈后可以对卡圈13进行嵌合胀紧卡紧,且上层球囊223的间隔层正位于圆周凹槽面高度可以对卡圈起到稳固作用。In the present utility model, the
当需要对患者管腔内部支架3处进行碘125粒子放射治疗时,初始状态第一套管21、第二套管22、第三套管23、导丝25依次套入,同时将第一套管21下段收拢腔内部收拢的上层球囊221与下层球囊231之间填入覆膜层1相关结构,向导管机构2输送至患者支架3位置时,向上拉起第一套管21使得第二套管22与第三套管23的下端均能够露出。先对第二充气单向阀接头217进行充气,气体通过第三套管23管壁内部的第二气道215进入至下层球囊231使其膨胀充盈,下层球囊231带动下方卡圈13撑至圆周形状,并将卡圈13的支架夹紧槽131卡紧在支架3的端口处。当下方的卡圈13卡紧支架3下端时,在通过上述相同操作将上方上层球囊221充气充盈并将上方的卡圈13卡紧在支架3上端的端口处,在卡圈13卡紧固定的过程中需注意将覆膜层1的粒子仓12与药物敷贴层11对应支架3的编织网网孔处,使得粒子仓层12与药物敷贴层11能够接触管腔壁组织从而对其周围肿瘤进行粒子放射治疗与麻醉缓释效果。上下卡圈13均卡紧固定后覆膜层1能够紧贴于支架内壁,上下相向卡紧配合使得整个结构固定更加稳固。上下方卡圈13的缓释麻醉药腔132在卡紧稳固的同时能够始终对患者管腔壁释放麻醉药液,配合覆膜层1的药物敷贴层11中固态的缓释麻醉剂配合粒子仓层12中碘125对肿瘤进行治疗。When it is necessary to perform iodine 125 particle radiation therapy on 3 parts of the stent inside the patient's lumen, the
该局麻缓释药物涂层支架的输送敷贴系统,具有如下优点:The delivery and application system of the local anesthesia sustained-release drug-coated stent has the following advantages:
1、覆膜层1脱离支架3单独存在,使得患者无需更换支架3即可通过覆膜层1与原有支架3保持相对固定对管腔内壁处肿瘤进行治疗,从而避免了更换支架3过程中对患者造成不必要的伤害以及手术治疗费用的增加;同时此设计也使得覆膜层1能够方便更换或者撤出,为后续手术操作提供了极大的方便。覆膜层1上圆周均匀分布的若干螺旋排布的粒子仓层12与设计有若干覆膜渗透孔111的药物敷贴层11可以装载碘125粒子与缓释麻醉药剂对肿瘤进行治疗。1. The
2、覆膜层1上下端连接的卡圈13设置的支架夹紧槽131方便对支架3的上下端口处进行卡紧从而使得覆膜层1与支架3相向卡紧固定无法松脱,卡圈13靠外侧上下位置设计的两个相互连通的缓释麻醉药腔132通过外侧壁的卡圈渗透孔135使得药腔内部的缓释麻醉药剂持续稳定的对管腔内壁起到缓释麻醉作用。2. The
3、上下两个卡圈13端口处的斜面134设计配合充盈后的上层球囊221与下层球囊231中间外圈圆周的让位槽面223嵌合卡紧可将卡圈13撑开,便于卡圈13卡紧于支架3端口处。通过间隔层设置为两个腔的目的在于可以通过间隔层的支撑,使得上层球囊221在充盈后的外圈中间位置具有一定的强度,不会像上层球囊231其他区域在触压后容易凹陷变形。3. The
在本实用新型中,如图15至图28所示,本实用新型提供一个实施例一,在该实施例一中,第一套管21内设置有螺旋收拢管218,第三套管23的下端设置有导管头232,导管头232上同轴连接有束紧套233,第二套管22与束紧套233之间套有夹紧支架224,螺旋收拢管218可套住夹紧支架224,夹紧支架224与螺旋收拢管218之间套住覆膜层1;第一套管21、第二套管22与第三套管23均设置有手柄端25;具体地讲,导管机构2从外至内同样为第一套管21依次套有第二套管22与第三套管23,第一套管21、第二套管22和第三套管23后方操纵端设置的一字型手柄端25均与前述的导管机构2一致。第一套管21下端的收拢腔211内部设置有螺旋收拢管218,螺旋收拢管218整体为圆筒状,在螺旋收拢管218内壁为若干圆周均匀分布的向轴线方向螺旋脊线式尖角形状。该螺旋收拢管218长度长于呈细长束紧状态的夹紧支架224,使得夹紧支架224能够完全被收至螺旋收拢管218内部。在第一套管21内部套置的第二套管22前端端口处内壁至向内的一定深度区域设计为台阶状结构,使得第二套管22前端端口处内壁的壁厚小于其余位置。在第二套管22内部套有第三套管23,第三套管23前段可延伸出第二套管22并延伸一定距离,在第三套管23前端端口处同轴固定连接有圆锥形的导管头232,在导管头232后端面同轴固定有束紧套233,束紧套233整体呈套筒状,且束紧套233间隙配合套于第三套管23上,内壁与第三套管23管壁有间距。套于第三套管23的第二套管22前段与束紧套233的内壁和第三套管23管壁之间套有夹紧支架224,夹紧支架224长度长于支架3。第二套管22前端与束紧套233分别束紧于夹紧支架224的两端,当第一套管21向前推动顶至导管头232时,第一套管21前端的螺旋收拢管218可套于夹紧支架224的外部。当螺旋收拢管218后撤将夹紧支架224段露出时,通过手持控制第二套管22与第三套管23的手柄端加大第二套管22与束紧套233之间的相对距离可以将夹紧支架224释放。在夹紧支架224与螺旋收拢管218之间套有覆膜层1,该实施例一的覆膜层1与前述的覆膜层1结构一致不多赘述。In the present invention, as shown in FIGS. 15 to 28 , the present invention provides a first embodiment. In the first embodiment, the
在该实施例一中,初始状态先将夹紧支架224拉至细长并将两端分别束套于第二套管22前段与导管头232后端束紧套内部,将覆膜层1套裹于夹紧支架224外周,并将第一套管21向前推动使得夹紧支架224与覆膜层1均收拢内套于螺旋收拢管218内部。螺旋收拢管218内壁的若干圆周均匀分布的向轴线方向螺旋脊线式尖角可以防止覆膜层1与夹紧支架224发生相对滑移甚至滑脱等情况出现,当第一套管21相对于第二套管22与第三套管23向后拉动带动螺旋收拢管218对覆膜层1与夹紧支架224逐渐释放时,可以始终通过螺旋收拢管218内壁的螺旋脊线式尖角对未释放段的覆膜层1与夹紧支架224起到稳固作用,能够在覆膜层1与夹紧支架224在完全脱离螺旋收拢管218之前始终能保持上述两者的相对固定。当螺旋收拢管218跟随第一套管21后拉完全释放束紧套与夹紧支架224后,只剩第二套管22前端台阶段与束紧套233对夹紧支架224的两端束紧,向前推动第二套管22的同时向后拉动第三套管23,使得第二套管22与束紧套233相对距离变小,在第二套管22台阶段端面与束紧套233前端导管头232后端面的顶推作用下使得夹紧支架224中间段膨胀隆起,从而夹紧支架223整体形成两头细中间粗的形状,夹紧支架224的中间段将覆膜层1撑至与管腔内部支架3紧贴。当覆膜层1与支架3的相对位置确定无误之后,向前推动第三套管23,第三套管23带动束紧套233向前推送使得夹紧支架224的前端端口逐渐脱离束紧233套,最终夹紧支架224的前端完全释放顶撑至管腔内壁上使得夹紧支架224与管腔壁相对固定。此时向后拉动第二套管22,释放夹紧支架224的另一端使得夹紧支架224完成顶撑至管腔内壁上,覆膜层1在支架3与夹紧支架224之间被完全夹紧固定,使得覆膜层1圆饼状的固态缓释麻醉药剂配合碘125粒子对管腔内壁的肿瘤进行治疗。In the first embodiment, in the initial state, the clamping
该实施例一具备如下优点:The first embodiment has the following advantages:
1、采用长度长于支架3的夹紧支架224将覆膜层1夹紧于支架3与夹紧支架224之间,使得覆膜层1完全固定从而对管腔内壁进行放射治疗,此种方式可以根据原有支架3的长度与规格任意更换对应的夹紧支架,具有通用型便于医生进行治疗,出现常规覆膜式支架紧贴于原有支架上因为长度覆膜支架过短治疗不充分或覆膜支架过长造成药剂悬空无法贴合至管腔内壁无法充分治疗。1. Use the
2、第二套管22的台阶段与束紧套233束紧夹紧支架224两端,螺旋收拢管218对夹紧支架224的中间段进行收拢束紧,使得夹紧支架224能够完全束紧,且螺旋收拢管218内壁的螺旋脊线式尖角对未释放段的覆膜层与夹紧支架224起到稳固作用,能够在覆膜层1与夹紧支架224在完全脱离螺旋收拢管218之前始终能保持上述两者的相对固定,便于夹紧支架224控制覆膜层1贴合至支架3准确位置,第二套管22台阶段端面与束紧套233前端导管头后端面起顶推作用。2. The stage stage of the
3、采用可以在释放时控制夹紧支架224中间段膨胀隆起,从而夹紧支架224整体形成两头细中间粗的形状,夹紧支架224的中间段将覆膜层1撑至与管腔内部支架3紧贴,使得覆膜层1紧贴找正位置后后续再完全释放,具有很高的容错率,避免出现像传统支架释放方式直接由细长束紧状态释放,位置出现偏差后无法滑移。3. The middle section of the
以上所述仅是本实用新型的优选实施方式,应当指出,对于本技术领域的普通技术人员来说,在不脱离本实用新型原理的前提下,还可以做出若干改进和润饰,这些改进和润饰也应视为本实用新型的保护范围。The above are only the preferred embodiments of the present invention. It should be pointed out that for those skilled in the art, without departing from the principles of the present invention, several improvements and modifications can be made. These improvements and Retouching should also be regarded as the protection scope of the present invention.
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