CN111820963A - New double-layer occluder - Google Patents
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- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
- A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
- A61B2017/00628—T-shaped occluders
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
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Abstract
Translated fromChinese
Description
Translated fromChinese技术领域technical field
本发明属于医疗设备技术领域，具体涉及一种用于瓣周漏、动脉导管未闭和室间隔缺损的经导管封堵的新型双层封堵器。The invention belongs to the technical field of medical equipment, and in particular relates to a novel double-layer occluder used for transcatheter occlusion of paravalvular leakage, patent ductus arteriosus and ventricular septal defect.
背景技术Background technique
瓣周漏是指经心脏瓣膜换瓣术后并发人工瓣膜周围漏，引起瓣膜反流，临床主要表现为与漏口及反流程度相关的溶血性贫血、心功能不全和感染性心内膜炎等。据美国的数据统计，约有2％-17％心脏瓣膜置换术后病人出现统计不同程度的瓣周漏。其中，二尖瓣瓣周漏(7％-17％)最为常见，主动脉瓣瓣周漏(2％-10％)次之，三尖瓣和肺动脉瓣瓣周漏较少发生。而既往观察性研究显示二尖瓣瓣周漏较主动脉瓣瓣周漏更易产生临床症状，且直径6mm-15mm的大型漏更易发生心功能不全，多发漏溶血几率更高。Paravalvular leakage refers to the leakage around the prosthetic valve after transcardiac valve replacement, which causes valve regurgitation. The main clinical manifestations are hemolytic anemia, cardiac insufficiency and infective endocarditis related to the degree of leakage and regurgitation. Wait. According to statistics from the United States, about 2%-17% of patients after heart valve replacement have statistical different degrees of paravalvular leakage. Among them, mitral valve paravalvular leakage (7%-17%) is the most common, followed by aortic valve paravalvular leakage (2%-10%), tricuspid valve and pulmonary valve paravalvular leakage occur less frequently. Previous observational studies have shown that mitral valve leakage is more likely to produce clinical symptoms than aortic paravalvular leakage, and large leakages with a diameter of 6mm-15mm are more prone to cardiac insufficiency, and the probability of multiple leakage hemolysis is higher.
瓣周漏治疗包括药物保守治疗、外科手术及经导管封堵。瓣周漏引起的溶血、贫血不严重，对血流动力学影响不明显，心功能良好者，可给予强心、利尿、抑制心脏重构等药物治疗，定期随访。除此之外的瓣周漏需要再次手术治疗，据统计产生临床症状、需要外科干预的瓣周漏发生率为1％-3％。既往对瓣周漏的治疗以外科手术为主，但外科再次手术风险较高，容易出现并发症，死亡率也相应增加，已行1次外科手术者死亡率13％，已行2次手术者15％，已行3次者37％。因此，于1992年由Hourihan等首次报道后，相继出现许多经导管封堵瓣周漏的报道，经导管瓣周漏封堵术逐渐成为临床治疗瓣周漏的首选策略。Paravalvular leak treatment includes conservative drug therapy, surgery, and transcatheter closure. Hemolysis and anemia caused by paravalvular leakage are not serious, and the effect on hemodynamics is not obvious. For those with good cardiac function, drug therapy such as cardiotonic, diuretic, and cardiac remodeling inhibition can be given, and regular follow-up is required. In addition, paravalvular leakage requires reoperation. According to statistics, the incidence of paravalvular leakage with clinical symptoms and requiring surgical intervention is 1%-3%. In the past, the treatment of paravalvular leakage was mainly surgery, but the risk of surgical reoperation was high, and complications were prone to occur, and the mortality rate also increased accordingly. 15%, 37% of those who have done it three times. Therefore, after the first report by Hourihan et al in 1992, there have been many reports of transcatheter paravalvular leak closure, and transcatheter paravalvular leak closure has gradually become the preferred strategy for clinical treatment of paravalvular leaks.
但是，目前瓣周漏封堵尚无专门的封堵器，临床常用有房缺封堵器、室缺封堵器、动脉导管未闭封堵器和血管塞封堵器等(如图1所示：A：血管塞封堵器I，B：血管塞封堵器II，C：动脉导管未闭封堵器，D：房缺封堵器，E：肌部室缺封堵器)。由于瓣周漏漏口形态多样，大小各异，距离人工瓣膜位置不一，并且不同瓣膜瓣周漏血流动力学不一致，使得目前临床应用的众多种类封堵器均存在缺陷，不能兼顾封堵器稳定性强、致溶血性弱和对人工瓣膜影响小等特性。理想的瓣周漏封堵器应该具有以下四种特征：1、自身径向支撑力强，释放后在瓣周漏位置稳定性强，不易脱落；2、器械变形能力强，适应于不同形态的瓣周漏；3、器械结构致密，红细胞不易通过，不易造成封堵器相关性溶血；4、器械变形固定后在瓣周漏上下残余部分不靠近人工瓣膜，不易影响人工瓣膜启闭。房缺封堵器伞盘大，虽然稳定性较强，封堵后残余漏较少，但容易影响人工瓣膜启闭，且房缺封堵器设计本是用于低压差的房间隔缺损，故用于高压差的瓣周漏封堵时，由于其内部结构不致密，非常容易引起机械性溶血。室缺封堵器和动脉导管未闭封堵器虽然较之房缺封堵器致密，减少了致溶血性，但在压差较高的二尖瓣瓣周漏封堵后仍有机械性溶血风险，再者，其伞盘小，稳定性降低，不易固定，变形性不足，容易有封堵后残余漏，且变形后伞盘容易影响人工瓣膜。血管塞封堵器I变形性好，适应于较多形态的瓣周漏，且没有伞盘，不易影响人工瓣膜，但是，减少伞盘导致其致密性降低，溶血发生率高。血管塞封堵器II由于特殊编织技术，伞体致密性高，大大减低致溶血性，且伞体变形性好，适应性强，但是其伞体径向支撑力差，稳定性不足，双侧伞盘大，容易影响人工瓣膜，具体特征比较见图2中的表1。However, at present, there is no special occluder for paravalvular leak closure. Commonly used clinically include atrial defect occluder, ventricular defect occluder, patent ductus arteriosus occluder and vascular plug occluder (Figure 1). Shown: A: Vascular plug occluder I, B: Vascular plug occluder II, C: Patent ductus arteriosus occluder, D: Atrial defect occluder, E: Muscular ventricular defect occluder). Due to the various shapes and sizes of paravalvular leaks, different positions from the prosthetic valve, and inconsistent hemodynamics of paravalvular leaks between different valves, many types of occluders currently used in clinical applications have defects and cannot take into account the occlusion. It has the characteristics of strong device stability, weak hemolysis and little impact on the artificial valve. An ideal paravalvular leak occluder should have the following four characteristics: 1. Strong radial support force, strong stability in the position of paravalvular leakage after release, and not easy to fall off; Paravalvular leakage; 3. The device structure is dense, red blood cells are not easy to pass, and it is not easy to cause occluder-related hemolysis; The umbrella disc of the atrial defect occluder is large, although it has strong stability and less residual leakage after occlusion, it is easy to affect the opening and closing of the artificial valve, and the atrial defect occluder is designed to be used for atrial septal defects with low pressure difference. When used for occlusion of paravalvular leaks with high pressure difference, it is very easy to cause mechanical hemolysis due to its non-dense internal structure. Although ventricular defect occluder and patent ductus arteriosus occluder are denser than atrial defect occluder and reduce hemolysis, they still have mechanical hemolysis after occlusion of mitral paravalvular leak with high pressure difference In addition, the umbrella disc is small, the stability is reduced, it is not easy to fix, the deformability is insufficient, and residual leakage after occlusion is likely to occur, and the deformed umbrella disc is likely to affect the artificial valve. Vascular plug occluder I has good deformability, is suitable for paravalvular leakage of many forms, and does not have umbrella disc, and is not easy to affect the artificial valve, but, reducing the umbrella disc causes its compactness to decrease, and the incidence of hemolysis is high. Due to the special weaving technology, the vascular plug occluder II has high compactness of the umbrella body, which greatly reduces hemolysis, and the umbrella body has good deformability and strong adaptability. However, the radial support force of the umbrella body is poor, the stability is insufficient, and the bilateral The umbrella disc is large and easily affects the artificial valve. The specific characteristics are compared in Table 1 in Figure 2.
动脉导管未闭和室间隔缺损均是常见的先天性心脏病，动脉导管未闭和室间隔缺损治疗的首选策略为微创经导管封堵术。由于通过动脉导管未闭和室间隔缺损的分流两端压力阶差大，既往动脉导管未闭和室间隔缺损封堵器封堵后存在溶血风险，同时由于动脉导管的形态各异，一些特殊形态病例(如长管型动脉导管)封堵器固定非常困难，没有针对长管型动脉导管未闭的合适封堵器。Both patent ductus arteriosus and ventricular septal defect are common congenital heart diseases. The preferred strategy for the treatment of patent ductus arteriosus and ventricular septal defect is minimally invasive transcatheter closure. Due to the large pressure gradient between the two ends of the shunt through patent ductus arteriosus and ventricular septal defect, there is a risk of hemolysis after occlusion of patent ductus arteriosus and ventricular septal defect occluder. Such as long-tube type ductus arteriosus) occluder fixation is very difficult, there is no suitable occluder for long-tube type patent ductus arteriosus.
发明内容SUMMARY OF THE INVENTION
有鉴于此，本发明的目的是提供一种新型双层封堵器，以解决现有技术中的不足。In view of this, the purpose of the present invention is to provide a novel double-layer occluder to solve the deficiencies in the prior art.
为了达到上述目的，本发明的目的是通过下述技术方案实现的：In order to achieve the above object, the purpose of the present invention is to realize through the following technical solutions:
提供一种新型双层封堵器，其中，包括封堵器体部，所述封堵器体部的上端设有固定器，所述封堵器体部的下端设有连接器，所述封堵器体部通过所述连接器连接外部输送钢缆，所述封堵器体部包括由金属丝构成的外层和内层，所述内层的金属丝和所述外层的金属丝的端部一头分别固定于所述固定器，另一头分别固定于所述连接器。A novel double-layer occluder is provided, which includes an occluder body, the upper end of the occluder body is provided with a fixer, the lower end of the occluder body is provided with a connector, and the occluder body is provided with a connector. The occluder body is connected to the external transmission steel cable through the connector, and the occluder body includes an outer layer and an inner layer composed of metal wires, and the metal wires of the inner layer and the metal wires of the outer layer are connected with each other. One end of the ends is respectively fixed to the holder, and the other end is respectively fixed to the connector.
上述新型双层封堵器，其中，所述内层的金属丝的直径大于所述外层的金属丝的直径，所述内层的金属丝的编织密度小于所述外层的金属丝的编织密度The above-mentioned novel double-layer occluder, wherein the diameter of the metal wire of the inner layer is larger than the diameter of the metal wire of the outer layer, and the weaving density of the metal wire of the inner layer is smaller than the weaving density of the metal wire of the outer layer density
上述新型双层封堵器，其中，所述内层的金属丝的直径为0.08mm，编织密度为72根丝，所述外层的金属丝的直径为0.04mm，编织密度为144-288根丝。The above-mentioned novel double-layer occluder, wherein the diameter of the metal wires of the inner layer is 0.08mm, the weaving density is 72 wires, the diameter of the metal wires of the outer layer is 0.04mm, and the weaving density is 144-288 wires Silk.
上述新型双层封堵器，其中，所述金属丝均为镍钛合金金属丝。In the above-mentioned novel double-layer occluder, the metal wires are all nickel-titanium alloy metal wires.
上述新型双层封堵器，其中，所述封堵器体部用于治疗瓣周漏且为纵向截面为矩形的圆柱型，所述封堵器体部的高度为15mm，所述封堵器体部的直径为6mm、8mm、10mm、12mm、14mm、16mm、18mm、20mm、22mm、24mm、26mm、28mm、30mm。The above-mentioned novel double-layer occluder, wherein the occluder body is used to treat paravalvular leakage and is a cylindrical shape with a rectangular longitudinal section, the height of the occluder body is 15 mm, and the occluder body is 15 mm. The diameter of the body is 6mm, 8mm, 10mm, 12mm, 14mm, 16mm, 18mm, 20mm, 22mm, 24mm, 26mm, 28mm, 30mm.
上述新型双层封堵器，其中，所述封堵器体部用于治疗动脉导管未闭且为纵向截面为“T”字形的圆柱型，所述封堵器体部包括上部和下部，所述封堵器体部的高度为7mm、9mm、11mm、13mm、15mm、17mm、19mm，所述封堵器体部的下部的直径为6mm、8mm、10mm、12mm、14mm、16mm、18mm、20mm、22mm、24mm、26mm、28mm。The above-mentioned novel double-layer occluder, wherein, the occluder body is used for the treatment of patent ductus arteriosus and is a cylindrical shape with a longitudinal cross-section of a "T" shape, and the occluder body includes an upper part and a lower part, so the The height of the occluder body is 7mm, 9mm, 11mm, 13mm, 15mm, 17mm, 19mm, and the diameter of the lower part of the occluder body is 6mm, 8mm, 10mm, 12mm, 14mm, 16mm, 18mm, 20mm , 22mm, 24mm, 26mm, 28mm.
上述新型双层封堵器，其中，所述封堵器体部用于治疗室间隔缺损且为纵向截面为“工”字形的圆柱型，所述封堵器体部包括上部、中部和下部，所述封堵器体部的高度为3mm、5mm、7mm、9mm，所述封堵器体部的中部的直径为4mm、5mm、6mm、7mm、8mm、9mm、10mm、11mm、12mm、13mm、14mm、15mm、16mm、17mm、18mm，所述封堵器体部的上部和中部的直径差为4mm、6mm、8mm、10mm，所述封堵器体部的下部的直径与所述封堵器体部的上部的直径相同。The above-mentioned novel double-layer occluder, wherein the occluder body is used for the treatment of ventricular septal defect and is a cylindrical shape with an "I"-shaped longitudinal section, and the occluder body includes an upper part, a middle part and a lower part, The height of the occluder body is 3mm, 5mm, 7mm, 9mm, and the diameter of the middle part of the occluder body is 4mm, 5mm, 6mm, 7mm, 8mm, 9mm, 10mm, 11mm, 12mm, 13mm, 14mm, 15mm, 16mm, 17mm, 18mm, the diameter difference between the upper part and the middle part of the occluder body is 4mm, 6mm, 8mm, 10mm, the diameter of the lower part of the occluder body is the same as the diameter of the occluder body The diameter of the upper part of the body is the same.
上述新型双层封堵器，其中，所述固定器为固定螺帽，所述连接器为连接螺帽，所述连接螺帽内部有螺纹卡口。In the above-mentioned novel double-layer occluder, the holder is a fixing nut, the connector is a connecting nut, and the connecting nut has a threaded bayonet inside.
本发明技术方案的有益效果是：The beneficial effects of the technical solution of the present invention are:
--具有稳定性好、解剖适应性强、不易溶血和瓣膜影响小的优势，以经导管介入方式完成瓣周漏、动脉导管未闭和室间隔缺损的封堵；--It has the advantages of good stability, strong anatomical adaptability, less hemolysis and less valve impact, and can complete the closure of paravalvular leakage, patent ductus arteriosus and ventricular septal defect by transcatheter intervention;
--自身径向支撑力强，释放后位置稳定性强，不易移位、脱落；-- Strong radial support force, strong position stability after release, not easy to shift or fall off;
--瓣周漏器械变形能力强，适应于不同形态的瓣周漏；-- The paravalvular leakage device has strong deformability and is suitable for different forms of paravalvular leakage;
--器械结构致密，红细胞不易通过，不易造成封堵器相关性溶血；--The structure of the device is dense, red blood cells are not easy to pass, and it is not easy to cause occluder-related hemolysis;
--器械变形固定后在瓣周漏上下残余部分少，不靠近人工瓣膜，不易影响人工瓣膜启闭；--After the device is deformed and fixed, there are few residual parts above and below the paravalvular leakage, not close to the artificial valve, and it is not easy to affect the opening and closing of the artificial valve;
--封堵器体部为纯镍钛合金丝结构，其内无需附加聚酯无纺布(PET)制成的阻流膜和缝线，因此压缩后直径更小，需要输送鞘的直径更小，对入路血管损伤小，血管并发症更少；--The body of the occluder is a pure nickel-titanium alloy wire structure, and there is no need for additional blocking films and sutures made of polyester non-woven fabric (PET), so the diameter after compression is smaller, and the diameter of the delivery sheath needs to be larger. Small, less damage to the access vessels, fewer vascular complications;
--动脉导管未闭封堵器的体部不同长度设计，适应长管型动脉导管解剖，让封堵更完全、稳定性强。--The patent ductus arteriosus occluder is designed with different body lengths, adapting to the anatomy of the long-tube ductus arteriosus, making the occlusion more complete and stable.
附图说明Description of drawings
图1为目前临床应用于经导管瓣周漏封堵的封堵器示意图；Fig. 1 is a schematic diagram of an occluder currently clinically applied to transcatheter paravalvular leak closure;
图2为现有临床应用于经导管瓣周漏封堵的封堵器的具体特征比较示意表格；Fig. 2 is a schematic table showing the comparison of the specific features of the occluder used for transcatheter paravalvular leakage occlusion in an existing clinical practice;
图3为本发明实施例一结构示意图；3 is a schematic structural diagram of
图4为本发明实施例二结构示意图；4 is a schematic structural diagram of
图5为本发明实施例三结构示意图；5 is a schematic structural diagram of
其中：1、封堵器体部；2、固定器；3、连接器；4、螺纹卡口；5、上部；6、下部；7、中部；11、外层；12、内层。Among them: 1. occluder body; 2. fixer; 3. connector; 4. threaded bayonet; 5. upper part; 6. lower part; 7. middle part; 11. outer layer; 12. inner layer.
具体实施方式Detailed ways
下面结合附图和具体实施例对本发明作进一步说明，但不作为本发明的限定。The present invention will be further described below with reference to the accompanying drawings and specific embodiments, but it is not intended to limit the present invention.
参看图3、图4和图5所示，本发明新型双层封堵器包括封堵器体部1，封堵器体部1的上端设有固定器2，封堵器体部1的下端设有连接器3，封堵器体部1通过连接器3连接外部输送钢缆，封堵器体部1包括由金属丝构成的外层11和内层12，内层12的金属丝和外层11的金属丝的端部一头分别固定于固定器2，另一头分别固定于连接器3。3, 4 and 5, the novel double-layer occluder of the present invention includes an
具体实施例中，封堵器体部1金属丝构成的外层11和内层12均由镍钛合金金属丝制成，内层12的镍钛金属丝较粗，直径为0.08mm，编织密度较稀疏，为72根丝，外层11的镍钛金属丝较细，直径为0.04mm，编织密度较密集，为144-288根丝。In the specific embodiment, the
进一步优选的方案中，固定器2为固定螺帽，连接器3为连接螺帽，固定螺帽和连接螺帽均由不锈钢制成，其中连接螺帽内部有螺纹卡口4，供输送钢缆连接。In a further preferred solution, the
使用时，将本封堵器通过连接螺帽与输送钢缆连接，通过输送钢缆在体外装载收入输送连接鞘，输送连接鞘与输送鞘连接后，通过推送钢缆来控制封堵器在输送鞘内及体内的位置。When in use, the occluder is connected to the delivery cable through the connecting nut, and the delivery cable is loaded into the delivery sheath outside the body. After the delivery sheath is connected to the delivery sheath, the occluder is controlled by pushing the cable. Intrathecal and in vivo location.
继续参看图3所示瓣周漏双层封堵器，封堵器体部1为纵向截面为矩形的圆柱型，封堵器体部1的高度为15mm，封堵器体部1的直径为6mm、8mm、10mm、12mm、14mm、16mm、18mm、20mm、22mm、24mm、26mm、28mm、30mm。Continue to refer to the paravalvular leakage double-layer occluder shown in FIG. 3, the
人工主动脉瓣瓣周漏封堵的简要手术步骤：①穿刺股动脉，并置入6F血管鞘，经股动脉送入导管及超滑导丝至升主动脉；②在导丝辅助下将导管通过人工主动脉瓣瓣周漏送入左室，再经导管交换入超硬支撑导丝至左室；③沿超硬支撑导丝送入输送鞘至左室；④沿输送鞘送入封堵器至输送鞘口，固定输送钢缆，回撤输送鞘，封堵器部分露出输送鞘；⑤继续回撤输送鞘，此时不固定输送钢缆，连同部分露出的封堵器一起退至瓣周漏位置；⑥固定输送钢缆，回撤输送鞘，使封堵器剩余部分全部露出输送鞘，并固定于瓣周漏的位置；⑦轻轻牵拉、推送输送钢缆，观察封堵器的稳定性；⑧确认封堵器稳定后，逆时针转动输送钢缆，使输送钢缆与封堵器脱离；⑨将输送钢缆回撤至输送鞘内，连同输送鞘一起撤出体外；⑩利用血管缝合器缝合股动脉穿刺口。人工二尖瓣瓣周漏封堵的简要手术步骤：①穿刺股动脉，并置入6F血管鞘，经股动脉送入导管及超滑导丝至左心室；②在导丝辅助下将导管通过人工二尖瓣瓣周漏送入左心房，再经导管交换入超硬支撑导丝至左房；③沿超硬支撑导丝送入输送鞘至左房；④沿输送鞘送入封堵器至输送鞘口，固定输送钢缆，回撤输送鞘，封堵器部分露出输送鞘；⑤继续回撤输送鞘，此时不固定输送钢缆，连同部分露出的封堵器一起退至瓣周漏位置；⑥固定输送钢缆，回撤输送鞘，使封堵器剩余部分全部露出输送鞘，并固定于瓣周漏的位置；⑦轻轻牵拉、推送输送钢缆，观察封堵器的稳定性；⑧确认封堵器稳定后，逆时针转动输送钢缆，使输送钢缆与封堵器脱离；⑨将输送钢缆回撤至输送鞘内，连同输送鞘一起撤出体外；⑩利用血管缝合器缝合股动脉穿刺口。A brief surgical procedure for occlusion of paravalvular leakage of prosthetic aortic valve: ①Puncture the femoral artery, insert a 6F vascular sheath, and send the catheter through the femoral artery and a super-sliding guidewire to the ascending aorta; ②Attach the catheter with the help of the guidewire The paravalvular leakage of the prosthetic aortic valve is sent into the left ventricle, and then the super-stiff support guide wire is exchanged through the catheter to the left ventricle; ③ The delivery sheath is sent along the super-stiff support guide wire to the left ventricle; Move the device to the delivery sheath mouth, fix the delivery wire cable, withdraw the delivery sheath, and the occluder partially exposes the delivery sheath; Perivalvular leakage position; ⑥Fix the delivery wire, withdraw the delivery sheath, so that the remaining part of the occluder is exposed to the delivery sheath, and fix it at the position of the paravalvular leakage; ⑦ Gently pull and push the delivery wire to observe the occluder ⑧ After confirming that the occluder is stable, turn the delivery cable counterclockwise to disengage the delivery cable from the occluder; ⑨ withdraw the delivery cable into the delivery sheath, and withdraw it from the body together with the delivery sheath; ⑩ Suture the femoral artery puncture port with a vascular stapler. A brief surgical procedure for occlusion of paravalvular leakage of the prosthetic mitral valve: ①Puncture the femoral artery, place a 6F vascular sheath, and deliver a catheter and a superslid guide wire to the left ventricle through the femoral artery; ② Pass the catheter through the guide wire with the help of the guide wire The paravalvular leakage of the prosthetic mitral valve is sent into the left atrium, and then the super-hard support guide wire is exchanged through the catheter to the left atrium; ③ The delivery sheath is sent to the left atrium along the super-hard support guide wire; ④ The occluder is sent along the delivery sheath To the delivery sheath mouth, fix the delivery wire cable, withdraw the delivery sheath, and the occluder partially exposes the delivery sheath; Leakage position; ⑥Fix the delivery wire, withdraw the delivery sheath, so that the remaining part of the occluder is exposed to the delivery sheath, and fixed at the position of the paravalvular leakage; ⑦ Gently pull and push the delivery wire, observe the occluder Stability; ⑧ After confirming that the occluder is stable, turn the delivery cable counterclockwise to separate the delivery cable from the occluder; ⑨ Retract the delivery cable into the delivery sheath, and withdraw it from the body together with the delivery sheath; ⑩ Use The vascular stapler sutures the femoral artery puncture.
继续参看图4所示动脉导管未闭双层封堵器，封堵器体部1为纵向截面为“T”字形的圆柱型，封堵器体部1包括上部5和下部6，封堵器体部1的高度为7mm、9mm、11mm、13mm、15mm、17mm、19mm，封堵器体部1的下部6的直径为6mm、8mm、10mm、12mm、14mm、16mm、18mm、20mm、22mm、24mm、26mm、28mm。Continue to refer to the patent ductus arteriosus double-layer occluder shown in Figure 4, the
动脉导管未闭封堵的简要手术步骤：①穿刺股动脉和股静脉，并分别置入6F血管鞘；②经股动脉送入导管及超滑导丝，将超滑导丝穿过动脉导管至肺动脉；③经股静脉送入圈套器，先后经右心房、右心室进入肺动脉，于肺动脉处圈套住超滑导丝，并将其拉出股静脉；④沿超滑导丝股静脉侧送入输送鞘至主动脉，并经输送鞘送入装载在输送钢缆上的封堵器；⑤通过回撤输送鞘，将封堵器释放在动脉导管处；⑥轻轻牵拉、推送输送钢缆，观察封堵器的稳定性；⑦自动脉侧造影确认封堵器位置、形态合适并且稳定后，逆时针转动输送钢缆，使输送钢缆与封堵器脱离；⑧将输送钢缆回撤至输送鞘内，连同输送鞘一起撤出体外；⑨利用血管缝合器缝合股动脉穿刺口，股静脉穿刺处压迫止血。Brief surgical steps for patent ductus arteriosus closure: ① puncture the femoral artery and femoral vein, and place 6F vascular sheaths respectively; ② send the catheter and super-sliding guide wire through the femoral artery, and pass the super-sliding guide wire through the ductus arteriosus to the ductus arteriosus. Pulmonary artery; ③Sent the snare through the femoral vein, enter the pulmonary artery successively through the right atrium and right ventricle, snare the super-sliding guide wire at the pulmonary artery, and pull it out of the femoral vein; The delivery sheath is sent to the aorta, and the occluder loaded on the delivery wire is sent through the delivery sheath; ⑤ The occluder is released at the arterial duct by retracting the delivery sheath; ⑥ Gently pull and push the delivery wire , observe the stability of the occluder; ⑦ After confirming the position, shape and stability of the occluder from the arterial angiography, turn the delivery cable counterclockwise to separate the delivery cable from the occluder; ⑧ withdraw the delivery cable into the delivery sheath and withdraw from the body together with the delivery sheath; ⑨ suture the puncture port of the femoral artery with a vascular stapler, and compress the puncture site of the femoral vein to stop the bleeding.
继续参看图5所示室间隔缺损双层封堵器，封堵器体部1为纵向截面为“工”字形的圆柱型，封堵器体部1包括上部5、中部7和下部6，封堵器体部1的高度为3mm、5mm、7mm、9mm，封堵器体部1的中部7的直径为4mm、5mm、6mm、7mm、8mm、9mm、10mm、11mm、12mm、13mm、14mm、15mm、16mm、17mm、18mm，封堵器体部1的上部5和中部7的直径差为4mm、6mm、8mm、10mm，封堵器体部1的下部6的直径与封堵器体部1的上部5的直径相同。Continue to refer to the double-layer occluder for ventricular septal defect shown in Fig. 5, the
室间隔缺损封堵的简要手术步骤：①穿刺股动脉和股静脉，并分别置入6F血管鞘；②经股动脉送入导管及超滑导丝，将超滑导丝穿过室间隔缺损至右心室，再达肺动脉；③经股静脉送入圈套器，先后经右心房、右心室进入肺动脉，于肺动脉处圈套住超滑导丝，并将其拉出股静脉；④沿超滑导丝股静脉侧送入输送鞘至主动脉，并经输送鞘送入装载在输送钢缆上的封堵器；⑤通过回撤输送鞘，将封堵器释放在室间隔缺损处；⑥轻轻牵拉、推送输送钢缆，观察封堵器的稳定性；⑦自左心室侧造影确认封堵器位置、形态合适并且稳定后，逆时针转动输送钢缆，使输送钢缆与封堵器脱离；⑧将输送钢缆回撤至输送鞘内，连同输送鞘一起撤出体外；⑨利用血管缝合器缝合股动脉穿刺口，股静脉穿刺处压迫止血。Brief surgical steps for ventricular septal defect closure: ① puncture the femoral artery and femoral vein, and place 6F vascular sheaths respectively; ② send the catheter and super-sliding guide wire through the femoral artery, and pass the super-sliding guide wire through the ventricular septal defect to the ventricular septal defect. Right ventricle, and then reach the pulmonary artery; ③ send the snare through the femoral vein, enter the pulmonary artery through the right atrium and the right ventricle successively, snare the super-smooth guide wire at the pulmonary artery, and pull it out of the femoral vein; ④ along the super-smooth guide wire The delivery sheath is sent to the aorta from the side of the femoral vein, and the occluder loaded on the delivery cable is sent through the delivery sheath; ⑤ The occluder is released at the ventricular septal defect by retracting the delivery sheath; ⑥ Gently pull Pull and push the delivery wire to observe the stability of the occluder; ⑦ After confirming the position, shape and stability of the occluder from left ventricular angiography, turn the delivery wire counterclockwise to separate the delivery wire from the occluder; ⑧ Withdraw the delivery wire cable into the delivery sheath, and withdraw from the body together with the delivery sheath; ⑨ Use a vascular stapler to suture the puncture port of the femoral artery, and compress the puncture site of the femoral vein to stop the bleeding.
以上仅为本发明较佳的实施例，并非因此限制本发明的实施方式及保护范围，对于本领域技术人员而言，应当能够意识到凡运用本发明说明书及图示内容所作出的等同替换和显而易见的变化所得到的方案，均应当包含在本发明的保护范围内。The above are only preferred embodiments of the present invention, and are not intended to limit the embodiments and protection scope of the present invention. For those skilled in the art, they should be aware of the equivalent replacement and Solutions obtained by obvious changes shall all be included in the protection scope of the present invention.
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