技术领域technical field
本实用新型涉及一种经皮介入减缓心力衰竭的器械。The utility model relates to a device for slowing down heart failure by percutaneous intervention.
背景技术Background technique
心力衰竭是心脏类疾病的终末状态，此时患者的心脏无法泵出足够的血流来满足机体的需求。心力衰竭会对极大降低患者的生活质量，会引发例如呼吸短促、持续咳嗽或喘息、机体组织中过度积液(水肿)、疲乏、食欲减退或恶心、思维迟钝、心率加快等临床表现。2010-2030年，由于人口老龄化与人口增长，中国心血管疾病发生数上升幅度将超过50％。随着老龄化脚步加快，心力衰竭的患病率逐年增高，成为严重的公共卫生问题。据报道，每年全球有1700万人死于心血管疾病，其中一半以上死于急性心肌梗死，即使患者存活后也容易发展为慢性心力衰竭。据估计中国急性心肌梗死的发病率约为45万～55万，目前仍呈上升趋势，心力衰竭患病率为0.9％，病因中冠心病由1980年的36.8％上升至2000年的45.6％，居各种病因之首。急性心肌梗死后大约有20％～50％的患者会发展为心力衰竭，特别是前壁心肌梗死，心力衰竭为各种心脏病的严重阶段，其发病率高，5年存活率与恶性肿瘤相仿。心肌梗死后，部分左室心肌发生坏死，继而出现心脏增大、心脏泵血功能降低、心输出量减少，导致呼吸困难等心力衰竭症状。对于缺血性心力衰竭，尽管临床医生可采用药物治疗和心脏再同步治疗(CRT)等器械治疗，但由于病因未能得以纠正，大部分患者的病情仍无法缓解，甚至可能恶化，预后也不理想。Heart failure is an end state of heart disease in which the heart cannot pump enough blood to meet the body's needs. Heart failure can greatly reduce a patient's quality of life, causing clinical manifestations such as shortness of breath, persistent coughing or wheezing, excessive fluid accumulation in body tissues (edema), fatigue, loss of appetite or nausea, slowed thinking, and increased heart rate. From 2010 to 2030, due to population aging and population growth, the incidence of cardiovascular diseases in China will increase by more than 50%. With the accelerated pace of aging, the prevalence of heart failure is increasing year by year, becoming a serious public health problem. According to reports, 17 million people die from cardiovascular diseases in the world every year, and more than half of them die from acute myocardial infarction. Even if patients survive, they are prone to develop chronic heart failure. It is estimated that the incidence of acute myocardial infarction in China is about 450,000 to 550,000, and it is still on the rise. The prevalence of heart failure is 0.9%, and the etiology of coronary heart disease has increased from 36.8% in 1980 to 45.6% in 2000. Ranked first among various causes of disease. About 20% to 50% of patients after acute myocardial infarction will develop heart failure, especially anterior wall myocardial infarction. Heart failure is a serious stage of various heart diseases. Its incidence rate is high, and its 5-year survival rate is similar to that of malignant tumors. . After myocardial infarction, part of the left ventricular myocardium undergoes necrosis, followed by heart enlargement, reduced heart pumping function, and reduced cardiac output, leading to heart failure symptoms such as dyspnea. For ischemic heart failure, although clinicians can use drug therapy and cardiac resynchronization therapy (CRT) and other devices for treatment, due to the failure of the cause to be corrected, the condition of most patients still cannot be relieved, and may even worsen, and the prognosis is not good. ideal.
左心室减容装置是一项经皮介入用于隔离病变心肌的的微创治疗技术，将坏死的心脏部分与健康的、有功能的部分隔离开来，从而缩小左心室的总容积，恢复其形态和功能。临床数据显示，患者接受类似左心室减容装置器械治疗后，心功能和生活质量出现总体改善。至今，国际上唯一的左心室减容装置有美国的Cardiokinetix公司发明Parachute左心室减容装置。如发明专利US7887477B2，US2014/0179993A1，US2014/0296624A1和US2014/0343356A1所述，该发明涉及一个倒置的伞状结构，由膨体聚四氟乙烯(ePTFE)覆膜固定于一个展开的镍钛(NiTi)形状记忆金属骨架上。在底座部分有一个花瓣形的塑料底座。在放置时根据术前超声心动图检查选择合适大小的左心室减容装置。首先将输送长鞘沿动脉血管通道，经股动脉，主动脉，主动脉瓣，将输送长鞘放到左心室心尖位置，接着在体外与推送杆装配好后，沿输送长鞘将左心室减容装置推送至左心室心尖部。固定推送杆，回撤输送长鞘在左心室心尖位置释放左心室减容装置的底座，继续回撤输送长鞘直至左心室减容装置出长鞘。扩张推送杆远端的球囊，使膨体聚四氟乙烯覆膜被动锚定在心内膜心肌上。The left ventricular volume reduction device is a minimally invasive treatment technology for percutaneous intervention to isolate the diseased myocardium. It isolates the necrotic heart part from the healthy and functional part, thereby reducing the total volume of the left ventricle and restoring its form and function. Clinical data show that after patients receive treatment with a device similar to the left ventricular volume reduction device, there is an overall improvement in cardiac function and quality of life. So far, the only left ventricular volume reduction device in the world is the Parachute left ventricular volume reduction device invented by Cardiokinetix in the United States. As described in the invention patents US7887477B2, US2014/0179993A1, US2014/0296624A1 and US2014/0343356A1, the invention relates to an inverted umbrella structure, which is fixed by an expanded polytetrafluoroethylene (ePTFE) coating on an expanded nickel-titanium (NiTi ) shape memory metal skeleton. In the base part there is a petal-shaped plastic base. Choose an appropriate size left ventricular volume reduction device according to the preoperative echocardiographic examination during placement. First, place the long delivery sheath along the arterial vessel channel, through the femoral artery, aorta, and aortic valve, and place the long delivery sheath at the apex of the left ventricle. The container is pushed to the apex of the left ventricle. Fix the push rod, withdraw the delivery long sheath to release the base of the left ventricular volume reduction device at the apex of the left ventricle, and continue to withdraw the delivery long sheath until the left ventricular volume reduction device comes out of the long sheath. The balloon distal to the pusher rod is inflated to passively anchor the expanded polytetrafluoroethylene graft to the endomyocardium.
发明内容Contents of the invention
本实用新型的目的是提供一种经皮介入减缓心力衰竭的器械。The purpose of the utility model is to provide a device for slowing heart failure through percutaneous intervention.
为了达到上述目的，本实用新型提供了一种经皮介入减缓心力衰竭的器械，其特征在于，包括镍钛合金编织支架，所述的镍钛合金编织支架包括近端编织部分、远端编织部分以及形成于所述的近端编织部分、远端编织部分之间的连接腰部，所述的远端编织部分具有椭圆形横截面，所述的远端编织部分固定连接3～12根倒刺。In order to achieve the above purpose, the utility model provides a device for slowing heart failure through percutaneous intervention, which is characterized in that it includes a nickel-titanium alloy braided stent, and the nickel-titanium alloy braided stent includes a proximal braided part and a distal braided part And the connecting waist formed between the proximal braided part and the distal braided part, the distal braided part has an oval cross-section, and the distal braided part is fixedly connected with 3-12 barbs.
进一步地，所述的连接腰部的中轴线与所述的远端编织部分的椭圆形横截面的短轴位于同一平面上，所述的倒刺和连接腰部分别位于所述的远端编织部分的椭圆形横截面的长轴的两侧。Further, the central axis of the connecting waist is on the same plane as the short axis of the elliptical cross-section of the distal braided part, and the barbs and the connecting waist are respectively located at the ends of the distal braided part. Both sides of the major axis of an elliptical cross-section.
进一步地，所述的远端编织部分和所述的近端编织部分皆为盘形，所述的近端编织部分的横截面为圆形，所述的远端编织部分与近端编织部分所在的平面相互平行，所述的连接腰部为圆柱形，其中轴线与所述的远端编织部分所在的平面垂直。Further, the braided portion at the distal end and the braided portion at the proximal end are disc-shaped, the braided portion at the proximal end is circular in cross section, and the braided portion at the distal end and the braided portion at the proximal end are located The planes are parallel to each other, the connecting waist is cylindrical, and its axis is perpendicular to the plane where the braided part of the distal end is located.
更进一步地，所述的远端编织部分由两层编织网构成，所述的两层编织网在所述的远端编织部分的外周边缘处紧密贴合。Furthermore, the braided part at the distal end is composed of two layers of braided nets, and the two layers of braided nets are closely attached at the outer peripheral edge of the braided part at the distal end.
更进一步地，所述的两层编织网的紧密贴合部分的宽度为2～5mm。Furthermore, the width of the tightly bonded part of the two-layer woven net is 2-5 mm.
更进一步地，所述的远端编织部分的椭圆形横截面的圆心为点O，所述的连接腰部在所述的远端编织部分的椭圆形横截面上的投影为圆形，该圆形的经过点O的两条切线的夹角α为0～30°，不包括0。Furthermore, the center of the elliptical cross-section of the braided part at the distal end is point O, and the projection of the connecting waist on the elliptical cross-section of the braided part at the distal end is a circle, and the circle The angle α between the two tangent lines passing through the point O is 0-30°, 0 is not included.
更进一步地，位于两侧的所述的倒刺与所述的远端编织部分的连接点在所述的远端编织部分的椭圆形横截面上的投影与所述的远端编织部分的椭圆形横截面的圆心之间连线的夹角β不大于120°。Furthermore, the projection of the connection points between the barbs on both sides and the distal braided part on the elliptical cross-section of the distal braided part is the same as the ellipse of the distal braided part The included angle β of the line connecting the centers of the cross-sections is not greater than 120°.
进一步地，所述的远端编织部分具有月牙形的纵截面，所述的近端编织部分为圆盘形，所述的近端编织部分所在的平面与所述的远端编织部分的椭圆形横截面垂直设置。Further, the braided part at the distal end has a crescent-shaped longitudinal section, the braided part at the proximal end is disc-shaped, and the plane where the braided part at the proximal end is located is in line with the oval shape of the braided part at the distal end. The cross section is set vertically.
进一步地，所述的远端编织部分、近端编织部分和连接腰部的内部或外部固定有用于阻隔血流的膜片。Further, a membrane for blocking blood flow is fixed inside or outside the braided part at the distal end, the braided part at the proximal end and the connecting waist.
进一步地，所述的近端编织部分结扎用与推送器头端连接的钢套。Further, the braided part at the proximal end is ligated with a steel sheath connected with the head end of the pusher.
本实用新型可将坏死的心脏部分与健康的、有功能的部分隔离开来，从而缩小左心室的总容积，恢复其形态和泵血功能。对于心肌梗死后室壁运动不协调或室壁瘤形成患者，本实用新型可隔离失活心肌所在的心室腔可改善左心室几何构型，降低左心室容积，防止心脏扩大，减小室壁张力，从而可预防左心室进一步发生重构。The utility model can isolate the necrotic heart part from the healthy and functional part, thereby reducing the total volume of the left ventricle and restoring its shape and blood pumping function. For patients with incoordination of ventricular wall motion after myocardial infarction or aneurysm formation, the utility model can isolate the ventricular cavity where the inactivated myocardium is located, improve the geometric configuration of the left ventricle, reduce the volume of the left ventricle, prevent heart enlargement, and reduce wall tension , thereby preventing further remodeling of the left ventricle.
与现有技术相比，本实用新型的有益效果是：Compared with the prior art, the beneficial effects of the utility model are:
1，本实用新型的器械经皮介入，创伤小，恢复快，并发症少；1. The percutaneous intervention of the instrument of the present utility model has the advantages of small trauma, fast recovery and few complications;
2，本实用新型的器械可释放后回收，便于术中调整器械稳定位置，起到最好预期效果；2. The instrument of the present invention can be released and recovered, which is convenient for adjusting the stable position of the instrument during the operation and achieves the best expected effect;
3，本实用新型的器械可经肌部室缺到达病变位置，对已硬化脆化的的心尖部位无损伤；3. The instrument of the present utility model can reach the lesion site through the muscular ventricular septum, without damage to the hardened and brittle apex of the heart;
4，肌部室缺与左室壁倒钩同时固定本实用新型的器械，稳定不易移位；4. Muscle ventricular septum and left ventricular wall barb fix the device of the utility model at the same time, which is stable and not easy to shift;
5，椭圆状设计，更好覆盖病变后心腔，完全隔离坏死的心脏部分与健康的、有功能的部分；5. The elliptical design can better cover the heart cavity after the lesion, and completely isolate the necrotic heart part from the healthy and functional part;
6，网状编织结构设计，柔软易变性，随心脏跳动紧密贴合心室壁；6. Mesh weaving structure design, soft and variable, closely adheres to the ventricular wall with the beating of the heart;
7，装置上缝有一层用于阻隔血流的膜片，完全阻断流动血液穿过此器械。7. There is a layer of membrane used to block blood flow sewn on the device, completely blocking the flow of blood through the device.
8，与先心病用封堵器输送方法类似，便于推广应用。8. Similar to the delivery method of the occluder for congenital heart disease, it is easy to popularize and apply.
附图说明Description of drawings
图1a和1b为实施例1中的经皮介入减缓心力衰竭的器械俯视图和剖面图；Figures 1a and 1b are top views and cross-sectional views of the device for slowing heart failure by percutaneous intervention in Example 1;
图2a和2b为实施例2中的经皮介入减缓心力衰竭的器械俯视图和剖面图；Figures 2a and 2b are top views and cross-sectional views of the percutaneous interventional device for slowing heart failure in Example 2;
图3为实施例1中的经皮介入减缓心力衰竭的器械使用状态图；Fig. 3 is a diagram of the use state of the device for slowing heart failure by percutaneous intervention in Example 1;
图4为实施例2中的经皮介入减缓心力衰竭的器械使用状态图；Fig. 4 is the diagram of the use state of the apparatus for slowing heart failure by percutaneous intervention in Example 2;
具体实施方式detailed description
下面结合具体实施例，进一步阐述本实用新型。应理解，这些实施例仅用于说明本实用新型而不用于限制本实用新型的范围。此外应理解，在阅读了本实用新型讲授的内容之后，本领域技术人员可以对本实用新型作各种改动或修改，这些等价形式同样落于本申请所附权利要求书所限定的范围。Below in conjunction with specific embodiment, further set forth the utility model. It should be understood that these embodiments are only used to illustrate the present utility model and are not intended to limit the scope of the present utility model. In addition, it should be understood that after reading the content taught by the utility model, those skilled in the art can make various changes or modifications to the utility model, and these equivalent forms also fall within the scope defined by the appended claims of the application.
实施例1Example 1
如图1a和1b所示，本实用新型的经皮介入减缓心力衰竭的器械，包括镍钛合金编织支架1，所述的镍钛合金编织支架1呈H形，由近端编织部分11、远端编织部分13以及形成于所述的近端编织部分11、远端编织部分13之间的连接腰部12组成，所述的远端编织部分13具有椭圆形横截面，所述的远端编织部分13固定连接3根倒刺2。所述的连接腰部12的中轴线与所述的远端编织部分13的椭圆形横截面的短轴位于同一平面上，所述的倒刺2和连接腰部12分别位于所述的远端编织部分13的椭圆形横截面的长轴的两侧。As shown in Figures 1a and 1b, the percutaneous interventional device for slowing heart failure of the present invention includes a nickel-titanium alloy braided stent 1. An end braided part 13 and a connecting waist 12 formed between the proximal braided part 11 and the distal braided part 13 are composed, the distal braided part 13 has an oval cross-section, and the distal braided part 13 fixedly connect 3 barbs 2. The central axis of the connecting waist 12 is on the same plane as the minor axis of the oval cross-section of the distal braided part 13, and the barbs 2 and the connecting waist 12 are located at the distal braided part respectively. 13 sides of the major axis of the elliptical cross-section.
所述的远端编织部分13和所述的近端编织部分11皆为盘形，所述的近端编织部分11的横截面为圆形，如图2所示，所述的远端编织部分13与近端编织部分11所在的平面相互平行，所述的连接腰部12为圆柱形，其中轴线与所述的远端编织部分13所在的平面垂直。The distal braided part 13 and the proximal braided part 11 are all disc-shaped, and the cross section of the proximal braided part 11 is circular, as shown in Figure 2, the distal braided part 13 and the plane where the proximal braided part 11 is located are parallel to each other, and the connecting waist 12 is cylindrical, and its axis is perpendicular to the plane where the distal braided part 13 is located.
所述的远端编织部分13由两层编织网构成，所述的两层编织网在所述的远端编织部分13的外周边缘处紧密贴合，所述的两层编织网的紧密贴合部分的宽度为3mm。所述的远端编织部分13的椭圆形横截面的圆心为点O，所述的连接腰部12在所述的远端编织部分13的椭圆形横截面上的投影为圆形，该圆形的经过点O的两条切线的夹角α为30°。位于两侧的所述的倒刺2与所述的远端编织部分13的连接点在所述的远端编织部分13的椭圆形横截面上的投影与所述的远端编织部分13的椭圆形横截面的圆心之间连线的夹角β不大于120°。The distal braided part 13 is composed of two layers of braided nets, and the two layers of braided nets are closely attached at the outer peripheral edge of the distal braided part 13, and the tight fit of the two layers of braided nets The width of the section is 3 mm. The center of the elliptical cross-section of the distal weaving portion 13 is point O, and the projection of the connecting waist 12 on the oval cross-section of the distal weaving portion 13 is a circle. The angle α between the two tangents passing through the point O is 30°. The projection of the connection point between the barbs 2 on both sides and the distal braided part 13 on the elliptical cross section of the distal braided part 13 and the ellipse of the distal braided part 13 The included angle β of the line connecting the centers of the cross-sections is not greater than 120°.
所述的远端编织部分13外侧热合一层用于阻隔血流的膜片4，其材料可以是ePTFE、PET等材料，近端编织部分11和连接腰部12内部均缝有一层用于阻隔血流的膜片4。The outer side of the braided part 13 at the distal end is heat-bonded with a layer of membrane 4 for blocking blood flow, and its material can be ePTFE, PET and other materials. Diaphragm 4 for flow.
所述的近端编织部分11结扎用与推送器头端连接的钢套。所述的钢套包含螺纹，可与推送器头端连接，与先心病用封堵器输送方法类似，便于推广应用。The braided portion 11 at the proximal end is ligated with a steel sheath connected to the head end of the pusher. The steel sleeve includes threads and can be connected to the head end of the pusher, which is similar to the delivery method of the occluder for congenital heart disease, and is convenient for popularization and application.
如图3所示，为实施例1中的经皮介入减缓心力衰竭的器械使用状态图。本实用新型的经皮介入减缓心力衰竭的器械的工作过程为:As shown in FIG. 3 , it is a diagram of the state of use of the device for relieving heart failure by percutaneous intervention in Example 1. The working process of the device for slowing heart failure by percutaneous intervention of the present utility model is:
首先经皮穿刺使用穿刺针在肌部室缺人造室间隔缺损；Firstly, a percutaneous puncture needle is used to artificially create a ventricular septal defect in the muscular ventricular septum;
首先将输送长鞘沿动脉血管通道，经股动脉、右心房、三尖瓣、人造室间隔缺损到达左心室壁未纤维化、钙化区域，接着在体外将钢套与推送杆装配好后，沿输送长鞘将本实用新型的经皮介入减缓心力衰竭的器械推送至左心室壁未纤维化、钙化区域，固定推送杆，回撤输送长鞘使倒刺2释放刺进左室壁，继续回撤输送长鞘释放远端编织部分13，待远端编织部分13与左室壁贴合后，进一步回撤输送长鞘，待远端编织部分13短端卡在人造室间隔左室侧稳定后，继续回撤装置，使连接腰部12完全释放，贴合人造室间隔，再释放近端编织部分11使其释放卡在右心室间隔，此时本实用新型在远端倒刺和近端“工”字形共同作用下稳定固定在心脏中，同时本实用新型的网状编织结构使得它的远端编织部分与左心室壁贴合，远端编织部分上热合的膜片阻断血液流动到膨大病变的心尖位置。同时，本实用新型在心脏中工作时的形态与正常心脏心尖形态类似，血液经二尖瓣到主动脉瓣流出之间在左心室内流动状态不会造成大的影响，利于心脏功能的回复。最后将推送器与本实用新型的经皮介入减缓心力衰竭的器械通过旋拧的方式分离释放，推送器和输送长鞘经动脉血管通道撤出，从而完成动脉穿刺的介入治疗。Firstly, the long delivery sheath is delivered along the arterial channel, through the femoral artery, right atrium, tricuspid valve, and artificial ventricular septal defect to the non-fibrotic and calcified area of the left ventricular wall, and then the steel sheath and the push rod are assembled in vitro, along the Transport the long sheath to push the device for percutaneous intervention to relieve heart failure of the present utility model to the non-fibrosis and calcified area of the left ventricle wall, fix the push rod, withdraw the transport long sheath to release the barb 2 and penetrate into the left ventricle wall, and continue to return Withdraw the delivery long sheath to release the distal braided part 13, and after the distal braided part 13 fits with the left ventricular wall, further withdraw the delivery long sheath, and wait for the short end of the distal braided part 13 to be stuck on the left ventricular side of the artificial interventricular septum and stabilize , continue to withdraw the device, so that the connecting waist 12 is completely released to fit the artificial interventricular septum, and then the proximal braided part 11 is released to release it stuck in the right ventricular septum. "" under the joint action of the shape, it is stably fixed in the heart, and at the same time, the net-like braided structure of the utility model makes its distal braided part adhere to the wall of the left ventricle, and the heat-sealed diaphragm on the distal braided part blocks blood from flowing to the enlarged lesion the apical position of the heart. At the same time, the shape of the utility model when working in the heart is similar to that of the apex of the normal heart, and the flow state of the blood in the left ventricle between the mitral valve and the aortic valve will not cause a major impact, which is beneficial to the recovery of heart function. Finally, the pusher and the device for slowing heart failure by percutaneous intervention of the present utility model are separated and released by twisting, and the pusher and the long delivery sheath are withdrawn through the arterial vascular channel, thereby completing the interventional treatment of arterial puncture.
实施例2Example 2
如图2a和2b所示，本实施例中的经皮介入减缓心力衰竭的器械结构类似于实施例1，区别在于，所述的远端编织部分13的形状不同，本实施例的远端编织部分13具有月牙形的纵截面，所述的近端编织部分11为圆盘形，所述的近端编织部分11所在的平面与所述的远端编织部分13的椭圆形横截面垂直设置。As shown in Figures 2a and 2b, the structure of the device for slowing heart failure by percutaneous intervention in this embodiment is similar to Embodiment 1, the difference is that the shape of the distal braided part 13 is different, and the distal braided part 13 of this embodiment The part 13 has a crescent-shaped longitudinal section, the proximal braided part 11 is disc-shaped, and the plane where the proximal braided part 11 is located is perpendicular to the elliptical cross-section of the distal braided part 13 .
如图4所示，为实施例2中的经皮介入减缓心力衰竭的器械使用状态图。本实施例的经皮介入减缓心力衰竭的器械的工作过程与实施例1相同。As shown in FIG. 4 , it is a diagram of the state of use of the device for relieving heart failure by percutaneous intervention in Example 2. The working process of the device for slowing heart failure by percutaneous intervention in this embodiment is the same as that in Embodiment 1.
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201520912376.XUCN205339013U (en) | 2015-11-16 | 2015-11-16 | Apparatus that slows down heart failure is intervene to percutaneous |
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201520912376.XUCN205339013U (en) | 2015-11-16 | 2015-11-16 | Apparatus that slows down heart failure is intervene to percutaneous |
| Publication Number | Publication Date |
|---|---|
| CN205339013Utrue CN205339013U (en) | 2016-06-29 |
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201520912376.XUActiveCN205339013U (en) | 2015-11-16 | 2015-11-16 | Apparatus that slows down heart failure is intervene to percutaneous |
| Country | Link |
|---|---|
| CN (1) | CN205339013U (en) |
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| Date | Code | Title | Description |
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| C14 | Grant of patent or utility model | ||
| GR01 | Patent grant |