CN211213711U - Controllable-caliber leakage-proof bracket for interventional TIPS (plastic surgery and surgical intervention) - Google Patents
Controllable-caliber leakage-proof bracket for interventional TIPS (plastic surgery and surgical intervention) Download PDFInfo
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- 238000002316 cosmetic surgery Methods 0.000 title 1
- 238000011477 surgical intervention Methods 0.000 title 1
- 238000001356 surgical procedure Methods 0.000 claims description 15
- 239000011248 coating agent Substances 0.000 claims description 12
- 238000000576 coating method Methods 0.000 claims description 12
- 239000003814 drug Substances 0.000 claims description 9
- 229940079593 drug Drugs 0.000 claims description 9
- 239000003805 procoagulant Substances 0.000 claims description 9
- 230000002265 prevention Effects 0.000 abstract 1
- 210000000013 bile duct Anatomy 0.000 description 8
- 238000000034 method Methods 0.000 description 7
- 239000008280 blood Substances 0.000 description 6
- 210000004369 blood Anatomy 0.000 description 6
- 230000017531 blood circulation Effects 0.000 description 5
- 230000000694 effects Effects 0.000 description 5
- 210000000941 bile Anatomy 0.000 description 4
- 201000010099 disease Diseases 0.000 description 4
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 4
- 238000002583 angiography Methods 0.000 description 3
- 210000003240 portal vein Anatomy 0.000 description 3
- 208000007536 Thrombosis Diseases 0.000 description 2
- 230000023555 blood coagulation Effects 0.000 description 2
- 208000007386 hepatic encephalopathy Diseases 0.000 description 2
- 210000002989 hepatic vein Anatomy 0.000 description 2
- 208000012671 Gastrointestinal haemorrhages Diseases 0.000 description 1
- 206010023126 Jaundice Diseases 0.000 description 1
- 230000000903 blocking effect Effects 0.000 description 1
- 210000004204 blood vessel Anatomy 0.000 description 1
- 208000019425 cirrhosis of liver Diseases 0.000 description 1
- 230000000295 complement effect Effects 0.000 description 1
- 238000010586 diagram Methods 0.000 description 1
- 208000030304 gastrointestinal bleeding Diseases 0.000 description 1
- 230000000004 hemodynamic effect Effects 0.000 description 1
- 238000002513 implantation Methods 0.000 description 1
- 210000003228 intrahepatic bile duct Anatomy 0.000 description 1
- 210000004731 jugular vein Anatomy 0.000 description 1
- 210000005228 liver tissue Anatomy 0.000 description 1
- 239000012528 membrane Substances 0.000 description 1
- 230000001681 protective effect Effects 0.000 description 1
- 208000024891 symptom Diseases 0.000 description 1
- 230000002792 vascular Effects 0.000 description 1
- 210000001631 vena cava inferior Anatomy 0.000 description 1
- 210000002620 vena cava superior Anatomy 0.000 description 1
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Abstract
Description
技术领域technical field
本实用新型涉及医疗器械技术领域,更具体地说它是介入TIPS手术用可控管径防漏支架。The utility model relates to the technical field of medical devices, in particular to a leak-proof stent with a controllable diameter for interventional TIPS surgery.
背景技术Background technique
介入TIPS(经颈静脉门体静脉分流术)是治疗因肝硬化导致消化道大出血的一种重要的手术方式。通过支架在肝内开通连接门静脉和肝静脉的血流通道是该手术最重要的环节。由于该手术方式发展时间较短,所用手术支架尚未十分成熟。在目前的临床实践中,若支架直径选择不合适,会导致血流通道狭窄不利于缓解病情,或者导致血流通道过宽引起严重的肝性脑病等并发症。Interventional TIPS (transjugular portosystemic shunt) is an important surgical method for the treatment of massive gastrointestinal bleeding due to liver cirrhosis. Opening the blood flow channel connecting the portal vein and the hepatic vein through the stent is the most important part of the operation. Due to the short development time of this surgical method, the surgical stent used is not yet very mature. In current clinical practice, if the diameter of the stent is not selected properly, it will lead to narrowing of the blood flow channel, which is not conducive to relieving the disease, or lead to excessive blood flow channel and cause serious complications such as hepatic encephalopathy.
目前的研究表明,用于TIPS的支架直径在6-10mm较为合适,但是存在以下几个问题:1)该研究结果局限于市场上常用支架直径的规格,还不够精确定量最佳直径;2)由于个体化的差异,上述研究结果不一定最适合于个体患者;3)术前根据术者预估的支架直径,在支架植入后只能对直径尺寸进行微调,若术后测压发现直径不合适,则该支架便不能有效缓解病情;4)在支架植入一段时间(数月至数年)后,支架内可能形成血栓堵塞支架内腔道导致病情再次加重;此时若因支架直径不可调整,则目前较好的治疗方式为再次行TIPS手术,但是再次TIPS手术的难度会大大增加,疗效也往往不如人意。The current research shows that the stent diameter of 6-10mm is suitable for TIPS, but there are several problems: 1) The results of this study are limited to the specifications of stent diameters commonly used in the market, and it is not enough to accurately quantify the optimal diameter; 2) Due to individual differences, the above research results may not be the most suitable for individual patients; 3) According to the stent diameter estimated by the surgeon before surgery, the diameter size can only be fine-tuned after stent implantation. If the stent is not suitable, the stent will not be able to effectively relieve the disease; 4) After the stent is implanted for a period of time (months to years), thrombus may form in the stent and block the lumen of the stent, causing the disease to worsen again; If it cannot be adjusted, the current better treatment method is to perform TIPS again.
由于肝内胆管和门静脉是紧密包裹在血管鞘内,穿刺血管建立通道过程中很可能会穿破胆管导致胆汁入血,引起黄疸等并发症。并且这种胆汁入血的并发症尚无很好的治疗方式。现阶段所用的支架包括覆膜支架,虽在一定程度上能缓解症状,但破裂的胆管并未得到有效处理。Since the intrahepatic bile duct and portal vein are tightly wrapped in the vascular sheath, the bile duct may be perforated during the process of puncturing the blood vessel to establish a channel, leading to bile into the blood, causing complications such as jaundice. And there is no good treatment for this complication of bile into the blood. The currently used stents include stent-grafts. Although the symptoms can be relieved to a certain extent, the ruptured bile duct has not been effectively treated.
基于以上背景,现亟需开发一种直径可依需要按不同梯度增加、且能治疗胆汁入血的介入TIPS手术用可控管径防漏支架。Based on the above background, there is an urgent need to develop a leak-proof stent with a controllable diameter for interventional TIPS surgery, which can be increased in diameter according to different gradients as required, and can treat bile intrusion.
发明内容SUMMARY OF THE INVENTION
本实用新型的目的是为了提供一种介入TIPS手术用可控管径防漏支架,直径可依需要按不同梯度增加,具有防漏功能,能有效缓解胆管破裂可能引起的并发症,结构精简,操作简便。The purpose of the utility model is to provide a leak-proof stent with a controllable diameter for interventional TIPS operation, the diameter can be increased according to different gradients as required, has a leak-proof function, can effectively alleviate the complications that may be caused by bile duct rupture, and has a simplified structure. Easy to operate.
为了实现上述目的,本实用新型的技术方案为:介入TIPS手术用可控管径防漏支架,包括网状结构支架主体,其特征在于:还包括可控环和覆膜;In order to achieve the above purpose, the technical scheme of the present utility model is as follows: a controllable diameter leak-proof stent for interventional TIPS operation, including a mesh structure stent body, and is characterized in that: it also includes a controllable ring and a membrane;
所述网状结构支架主体两端设有所述可控环;The controllable rings are provided at both ends of the main body of the mesh structure bracket;
所述可控环为空心环状体;所述可控环包括第一端部和第二端部;所述第一端部的孔径大于所述第二端部的孔径;The controllable ring is a hollow annular body; the controllable ring includes a first end and a second end; the aperture of the first end is larger than the aperture of the second end;
所述第二端部套在所述第一端部内。The second end is nested within the first end.
在上述技术方案中,有齿槽设于所述第一端部内壁上;所述齿槽有多个;In the above technical solution, tooth slots are provided on the inner wall of the first end portion; there are multiple tooth slots;
相邻二个所述齿槽的间距设置为πmm。The distance between two adjacent tooth slots is set to πmm.
在上述技术方案中,有齿凸设于所述第二端部外壁上;所述齿凸与所述齿槽配合连接。In the above technical solution, a toothed protrusion is provided on the outer wall of the second end portion; the toothed protrusion is matched and connected with the tooth groove.
在上述技术方案中,所述齿槽有七个;所述齿凸至少有一个。In the above technical solution, there are seven tooth slots and at least one tooth protrusion.
在上述技术方案中,所述覆膜贴附在所述网状结构支架主体外壁上;所述覆膜外侧设有促凝血药物涂层。In the above technical solution, the covering film is attached to the outer wall of the main body of the mesh structure stent; the outer side of the covering film is provided with a procoagulant drug coating.
本实用新型具有如下优点:The utility model has the following advantages:
(1)本实用新型结构精简,操作简便;(1) The utility model is simple in structure and easy to operate;
(2)本实用新型能提升TIPS手术效果,减小并发症出现的可能性;(2) the utility model can improve the TIPS operation effect and reduce the possibility of complications;
(3)本实用新型网状结构支架主体两端为圆形空心套环结构,基本不影响血流动力学;(3) The two ends of the main body of the mesh structure stent of the present invention are circular hollow collar structures, which basically do not affect the hemodynamics;
(4)本实用新型网状结构支架主体两端为圆形空心套环结构、且设有齿槽和齿凸结构,能够定量控制支架管径大小;可以实现从小管径开始操作,若小管径尚未达到缓解病情的最佳状态,可再次扩大管径,从而尽量减小肝性脑病等并发症的发生;(4) The two ends of the main body of the mesh structure stent of the present utility model are circular hollow collar structures, and are provided with tooth grooves and tooth convex structures, which can quantitatively control the diameter of the stent; If the diameter of the tube has not yet reached the optimal state for remission of the disease, the diameter of the tube can be expanded again to minimize the occurrence of complications such as hepatic encephalopathy;
(5)本实用新型在第一次术中可按需依次调整不同支架直径,且术后还可根据需要再次调整支架直径;克服了现有技术的介入TIPS手术用支架限于术前根据术者预估而选定的支架直径,仅能在第一次术中对管径进行微调的缺点;克服了现有技术中支架置入术后一段时间后发生堵塞,不易经原输送通道改善患者病情的缺点;(5) The utility model can adjust the diameter of different stents as needed in the first operation, and can adjust the diameter of the stent again after the operation; it overcomes the limitation of the stent for interventional TIPS operation in the prior art, which is limited by the operator before the operation. The estimated and selected stent diameter can only fine-tune the diameter of the tube in the first operation; it overcomes the blockage after a period of time after stent placement in the prior art, and it is not easy to improve the patient's condition through the original delivery channel Shortcomings;
(6)本实用新型的防漏功能通过支架主体上的覆膜及覆膜外侧面的促凝血药物涂层实现:第一,覆膜起到隔绝网状结构支架主体内外空间的作用,在一定程度上防止胆汁通过支架网眼入血;第二,促凝血药物涂层上的促凝血药物能促进血液凝固,凝固的血液将手术过程中穿破的临近胆道进行覆盖封堵,与覆膜作用互补,从而有效防止胆管破裂可能引起的并发症;(6) The leak-proof function of the present invention is realized by the coating on the main body of the stent and the procoagulant drug coating on the outer side of the coating. To a certain extent, it prevents bile from entering the blood through the stent mesh; secondly, the procoagulant drug on the procoagulant drug coating can promote blood coagulation, and the coagulated blood will cover and block the adjacent bile ducts that have been broken during the operation, which is complementary to the covering effect. , so as to effectively prevent the complications that may be caused by bile duct rupture;
本实用新型提供一种能针对个体患者病情的能定量控制管径的介入TIPS手术用可控管径防漏支架,具有如下功能:第一,本实用新型可依据患者术中或术后不同阶段的病情,调整支架的直径,或者在支架堵塞后再次经原输送通道扩大支架直径,能简便、有效地缓解患者病情;第二,本实用新型支架主体覆膜外的促凝血药物涂层,可通过凝固的血液封堵穿破的胆管,能有效防止胆管破裂可能引起的并发症;第三,将本实用新型详尽的直径数据及相应患者的治疗效果相匹配分析得到的研究数据,能为未来类似患者的治疗提供科学指导依据;本实用新型不仅能促进该手术方式的临床研究,更重要的是能最终为现在以及将来的患者实现最佳的治疗效果。The utility model provides a controllable diameter leak-proof stent for interventional TIPS surgery, which can quantitatively control the diameter of the tube according to the condition of the individual patient, and has the following functions: First, the present invention can be used according to the different stages of the patient during the operation or after the operation. Adjusting the diameter of the stent, or expanding the diameter of the stent through the original delivery channel after the stent is blocked, can easily and effectively relieve the patient's condition; Blocking the ruptured bile duct with coagulated blood can effectively prevent complications that may be caused by bile duct rupture; The treatment of similar patients provides scientific guidance basis; the utility model can not only promote the clinical research of the operation method, but more importantly, can finally achieve the best treatment effect for current and future patients.
附图说明Description of drawings
图1为本实用新型立体结构示意图。Figure 1 is a schematic diagram of the three-dimensional structure of the present invention.
图2为图1的A处放大图。FIG. 2 is an enlarged view of part A of FIG. 1 .
图中1-可控环,1.1-第一端部,1.11-齿槽,1.2-第二端部,1.21-齿凸,2-网状结构支架主体,3-覆膜,4-促凝血药物涂层,5-介入TIPS手术用可控管径防漏支架。In the figure, 1-controllable ring, 1.1-first end, 1.11-alveolar, 1.2-second end, 1.21-tooth convexity, 2-net structure stent body, 3-film, 4-procoagulant drug Coated, 5-controllable diameter leak-proof stent for interventional TIPS surgery.
具体实施方式Detailed ways
下面结合附图详细说明本实用新型的实施情况,但它们并不构成对本实用新型的限定,仅作举例而已。同时通过说明使本实用新型的优点更加清楚和容易理解。The implementation of the present utility model will be described in detail below with reference to the accompanying drawings, but they do not constitute a limitation to the present utility model, but only serve as examples. At the same time, the advantages of the present invention are made clearer and easier to understand through the description.
参阅附图可知:介入TIPS手术用可控管径防漏支架,包括网状结构支架主体2,还包括可控环1和覆膜3;Referring to the accompanying drawings, it can be known that the controllable diameter leak-proof stent for interventional TIPS operation includes a mesh structure
所述网状结构支架主体2上下两端设有所述可控环1;所述可控环1为空心环状体;所述可控环1包括第一端部1.1和第二端部1.2;所述第一端部1.1的孔径大于所述第二端部1.2的孔径;The
所述第二端部1.2套在所述第一端部1.1内(如图1所示)、并且可以向外拔出,从而扩大介入TIPS手术用可控管径防漏支架5的管径;本实用新型结构稳固,提升TIPS手术效果,减小并发症出现的可能性。The second end portion 1.2 is sheathed in the first end portion 1.1 (as shown in Figure 1), and can be pulled out, thereby expanding the diameter of the controllable diameter leak-
进一步地,有齿槽1.11设于所述第一端部1.1内壁上;所述齿槽1.11有多个;齿槽1.1.1为类直角三角形;但不限于此种形状,其性状只要能达到卡住的效果即可;Further, a toothed slot 1.11 is provided on the inner wall of the first end portion 1.1; there are multiple toothed slots 1.11; the toothed slot 1.1.1 is a right-angled triangle; The effect of being stuck can be;
相邻二个所述齿槽1.11的间距设置为πmm;本实用新型的直径可依需要按不同梯度增大,将本实用新型支架直径设置为5-11mm,周长为πd,直径每增加1mm,周长即增加πmm,相邻两个齿槽的间距也就为πmm;从5到11mm共设七个梯度,即5,6,7,8,9,10,11mm,因此齿槽也有七个;也可以根据实际需要设置为其他间距;克服了现常用支架直径为定值(为6-10mm),不能根据需要调节其大小的缺点。The spacing between two adjacent tooth slots 1.11 is set to πmm; the diameter of the utility model can be increased according to different gradients as required, the diameter of the utility model bracket is set to 5-11mm, the circumference is πd, and the diameter is increased by 1mm each time , the circumference is increased by πmm, and the distance between two adjacent tooth slots is also πmm; there are seven gradients from 5 to 11mm, namely 5, 6, 7, 8, 9, 10, 11mm, so there are also seven tooth slots. It can also be set to other distances according to actual needs; it overcomes the disadvantage that the diameter of the commonly used bracket is a fixed value (6-10mm), and its size cannot be adjusted according to needs.
进一步地,有齿凸1.21设于所述第二端部1.2外壁上;(如图2所示);该齿凸为与齿槽相匹配的类直角三角形;所述齿凸1.21与所述齿槽1.11配合连接;齿凸1.21与齿槽1.11紧密连接,防止介入TIPS手术用可控管径防漏支架5滑脱。Further, a toothed protrusion 1.21 is provided on the outer wall of the second end portion 1.2; (as shown in Figure 2); the toothed protrusion is a right-angled triangle that matches with the tooth slot; the toothed protrusion 1.21 and the toothed protrusion The groove 1.11 is matched and connected; the tooth protrusion 1.21 is closely connected with the tooth groove 1.11 to prevent the controllable diameter leak-
进一步地,所述齿槽1.11有七个;所述齿凸1.21至少有一个;齿槽1.11与齿凸1.21扣合紧密,防止介入TIPS手术用可控管径防漏支架5滑脱。Further, there are seven tooth grooves 1.11; at least one tooth convexity 1.21; tooth grooves 1.11 and tooth convexity 1.21 are tightly fastened to prevent slippage of the controllable diameter leak-
更进一步地,所述覆膜3贴附在所述网状结构支架主体2外壁上;所述覆膜3外侧涂敷促凝血药物涂层4(如图1所示);促凝血药物涂层4涂在覆膜3的外侧,即涂覆在覆膜3与肝组织穿刺道接触的一侧;Further, the
促凝血药物涂层可促进血液凝固,使在建立血流通道过程中产生的血液形成血栓,从而覆盖堵塞毗邻的受损胆管。The procoagulant drug coating promotes blood clotting, causing the blood produced during the establishment of blood flow channels to form a thrombus, covering the adjacent damaged bile duct.
如图1、图2所示:本实用新型所述的介入TIPS手术用可控管径防漏支架的工作过程如下:As shown in Figure 1 and Figure 2: the working process of the controllable diameter leak-proof stent for interventional TIPS operation described in the present invention is as follows:
步骤1:使用前,介入TIPS手术用可控管径防漏支架5常规压缩到最小直径后置于保护套内;Step 1: Before use, the controllable diameter leak-
步骤2:常规建立输送通道,将介入TIPS手术用可控管径防漏支架5系统输送至肝内输送通道的合适位置后释放;介入TIPS手术用可控管径防漏支架5的输送通道依次为:颈外静脉、上腔静脉、下腔静脉、肝静脉、肝内穿刺道、门静脉;Step 2: Routinely establish a delivery channel, transport the controllable diameter leak-
步骤3:当需要增大介入TIPS手术用可控管径防漏支架5的管径时,通过球囊将网状结构支架主体2管径扩张到较小程度(比初始管径稍大);Step 3: When it is necessary to increase the diameter of the leak-
步骤4:造影观察血流情况,若造影结果不满意,则再次使用球囊扩张网状结构支架主体2管径,直至影结果满意;Step 4: Observe the blood flow by angiography. If the angiography result is not satisfactory, use the balloon again to expand the diameter of the
步骤5:若介入TIPS手术用可控管径防漏支架5在一段时间后堵塞,可再次经步骤2所述的介入TIPS手术用可控管径防漏支架5的输送通道通过球囊对网状结构支架主体2管径进行扩大,直至满足临床需求。Step 5: If the controllable diameter leak-
实际使用中,本实用新型的各个部件可以根据需求改变直径。In actual use, the diameters of the various components of the present invention can be changed according to requirements.
其它未说明的部分均属于现有技术。Other unexplained parts belong to the prior art.
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Granted publication date: 20200811 Termination date: 20210906 |