技术领域technical field
本发明涉及医疗器械领域，特别是一种主动脉覆膜分支支架。The invention relates to the field of medical devices, in particular to an aortic covered branch stent.
背景技术Background technique
心血管疾病是目前威胁国人健康的第一杀手，主动脉瘤是最凶险的急、重症心血管疾病之一，临床上形象的称为“定时炸弹”。目前，治疗主动脉病变包括药物治疗、外科手术治疗、介入治疗等方法。药物治疗方面主要是通过严格控制血压来降低动脉瘤继续扩大或破裂的发生率。外科手术治疗方面主要是动脉瘤切除与人造或同种血管移植术，目前腹主动脉瘤的手术死亡率低于5％，但年龄过大，有心、脑、肾或其它内脏损害者，手术死亡可超过25％。胸主动脉瘤的手术死亡率在30％，以主动脉弓动脉瘤的手术危险性最大。但手术在深低温体外循环下进行，并存在脊髓、大脑及重要脏器缺血坏死的风险，很多老年患者由于存在高危因素无法耐受开胸下外科手术治疗而丧失治疗机会。Cardiovascular disease is currently the number one killer threatening the health of Chinese people. Aortic aneurysm is one of the most dangerous acute and severe cardiovascular diseases. It is clinically called a "time bomb". At present, the treatment of aortic lesions includes drug therapy, surgical treatment, interventional therapy and other methods. Drug treatment is mainly to reduce the incidence of aneurysm expansion or rupture through strict control of blood pressure. Surgical treatment is mainly aneurysm resection and artificial or homovascular grafting. At present, the surgical mortality rate of abdominal aortic aneurysm is less than 5%. Can exceed 25%. The surgical mortality rate of thoracic aortic aneurysm is 30%, and the surgical risk of aortic arch aneurysm is the greatest. However, the operation is performed under deep hypothermic extracorporeal circulation, and there is a risk of ischemic necrosis of the spinal cord, brain, and important organs. Many elderly patients are unable to tolerate surgical treatment under open thoracotomy due to high risk factors and lose the opportunity for treatment.
随着介入材料的发展进步与广泛应用，覆膜支架应用越来越广泛，传统的覆膜支架主要由金属丝及覆盖在其上的覆膜组成，这种支架可以发生形变，在常态下支架是直的，但支架一旦被植入主动脉中时，便是可以弯曲，使之能够与呈弓形的主动脉相适应，支架一旦弯曲势必会产生使之恢复成原来形状的力，这个力会给主动脉带来一定的压力，有时会导致主动脉的损伤。另外，现在市面上还出现了许多带分支架的覆膜支架，这种覆膜支架的分支架与主支架的侧壁连接并与主支架联通，因为设有分支架，所以这种带分支架的覆膜支架在植入主动脉中时，操作起来更加不便，一旦在释放压缩的覆膜支架时，如果分支架没有对齐相应的血管，就会出现封堵血管的情况，可能出现患者死亡的情况。综上所述，有必要设计出一种形状与弓形主动脉形状相适应的覆膜支架，且该覆膜支架所设有的分支架是可伸缩的，这种支架不仅不会给主动脉带来压力，而且能够更便捷的植入主动脉中。With the development, progress and wide application of interventional materials, covered stents are more and more widely used. Traditional covered stents are mainly composed of metal wires and covering films on them. This kind of stent can be deformed. It is straight, but once the stent is implanted in the aorta, it can be bent so that it can adapt to the arched aorta. Once the stent is bent, it will inevitably produce a force to restore it to its original shape. This force will Putting pressure on the aorta can sometimes lead to damage to the aorta. In addition, there are many covered stents with sub-stents on the market. The sub-stents of this covered stent are connected to the side wall of the main stent and communicate with the main stent. Because there are sub-stents, this kind of sub-stent When the covered stent graft is implanted in the aorta, it is more inconvenient to operate. Once the compressed covered stent graft is released, if the sub-stent is not aligned with the corresponding blood vessel, the blood vessel will be blocked, and the patient may die. Condition. In summary, it is necessary to design a stent graft whose shape is compatible with the shape of the arcuate aorta, and the sub-stents of the stent graft are scalable, and this stent will not bring the aorta To reduce pressure, and can be more easily implanted in the aorta.
发明内容Contents of the invention
本发明的目的在于提供一种结构简单、操作便捷且不会对主动脉带来压力的主动脉覆膜分支支架。The object of the present invention is to provide an aortic graft graft stent with simple structure, convenient operation and no pressure on the aorta.
本发明的目的通过如下技术方案实现：一种主动脉覆膜分支支架，它包括放于主动脉中的主支架以及设于主支架侧壁外侧并与主支架联通的分支架，所述的主支架包括覆膜以及支撑覆膜的若干圈波形环状物，波形环状物的波距以及相邻波峰与波谷之间的距离由弓弧形的内侧向外侧逐渐递增，使得主支架自然展开后的形状呈弓弧形，分支架包括分支架覆膜以及支撑分支架覆膜伸缩式的弹簧结构，分支架的底端与主支架侧壁外侧连接，波形环状物使得主支架能够通过若干个收紧装置使主支架收紧至口径缩小并维持收紧的状态；弹簧结构使分支架能够通过一压缩装置使分支架压缩并维持压缩状态。The object of the present invention is achieved through the following technical solutions: a branch stent graft of the aorta, which includes a main stent placed in the aorta and a sub-stent located outside the side wall of the main stent and communicated with the main stent, the main stent The stent consists of a membrane and a number of wave-shaped rings supporting the membrane. The wave distance of the wave-shaped ring and the distance between adjacent peaks and troughs gradually increase from the inside to the outside of the arch, so that after the main stent is naturally deployed The shape of the sub-stent is arc-shaped. The sub-stent includes the sub-stent coating and the telescopic spring structure supporting the sub-stent coating. The bottom end of the sub-stent is connected to the outside of the side wall of the main bracket. The tightening device tightens the main bracket until the caliber is reduced and maintains the tightened state; the spring structure enables the sub-support to compress the sub-support through a compression device and maintain the compressed state.
较之现有技术而言，本发明的优点在于：1)本发明结构简单，操作便捷；2)本发明的主支架在自然状态下呈弓弧形，使用时不会对主动脉带来压力，从而不会损伤主动脉；3)本发明的分支架为可伸缩的弹簧形，且分支架通过一压缩装置进行压缩并定型，使得分支架保持压缩状态，因为该主动脉覆膜分支支架在植入主动脉前，分支架处于被压缩的状态，所以该主动脉覆膜分支支架在植入主动脉的操作过程中，更容易植入主动脉；4)本发明的主支架，在植入主动脉前，主支架的口径在收紧装置的作用下收缩到最小，这样方便支架的植入，待支架植入到主动脉中的合适位置时，通过解开定位绳A，使主支架释放，所以本发明符合人体解剖学主动脉弓部特点，可以适合不同的个体，可以最大程度满足个体差异，同时，输送及释放系统简单，临床容易操作；5)本发明采用相互配合的收紧绳A与定位绳A来收紧主支架、采用相互配合的收紧绳B与定位绳B来压缩分支架，方便了主支架与分支架的释放，有效的节约了手术时间，当需要释放主支架时，只需抽走定位绳A即可，同理当需要释放分支架时，只需抽走定位绳B即可。6)当分支架的束缚被解除后，分支架可依靠其弹簧结构，自动突入分支血管中，而不需要依靠其他输送装置将其运送到分支血管，所以，分支架的植入方式较以往更为简便和安全，对血管的损伤也更小。Compared with the prior art, the present invention has the following advantages: 1) the present invention is simple in structure and convenient to operate; 2) the main stent of the present invention is arc-shaped in a natural state, and will not bring pressure to the aorta during use , so as not to damage the aorta; 3) the sub-stent of the present invention is a stretchable spring shape, and the sub-stent is compressed and shaped by a compression device, so that the sub-stent remains compressed, because the aortic covered branch stent is in the Before being implanted into the aorta, the sub-stent is in a compressed state, so the aortic covered branch stent is more easily implanted into the aorta during the operation of implanting the aorta; 4) the main stent of the present invention, when implanted In front of the aorta, the caliber of the main stent shrinks to the minimum under the action of the tightening device, which facilitates the implantation of the stent. When the stent is implanted in a suitable position in the aorta, the main stent is released by untying the positioning rope A , so the present invention conforms to the characteristics of the aortic arch of human anatomy, can be suitable for different individuals, and can meet individual differences to the greatest extent. At the same time, the delivery and release system is simple and easy to operate clinically; The positioning rope A is used to tighten the main bracket, and the coordinated tightening rope B and positioning rope B are used to compress the sub-stent, which facilitates the release of the main bracket and the sub-stent, and effectively saves the operation time. When the main bracket needs to be released, You only need to pull out the positioning rope A. Similarly, when you need to release the sub-support, you only need to pull out the positioning rope B. 6) When the restraint of the sub-stent is released, the sub-stent can rely on its spring structure to automatically break into the branch blood vessel without relying on other delivery devices to transport it to the branch blood vessel. Therefore, the implantation method of the sub-stent is more convenient than before. Simple and safe, less damage to blood vessels.
附图说明Description of drawings
图1是本发明分支架、主支架均压缩时的结构示意图。Fig. 1 is a schematic structural view of the sub-stent and the main stent of the present invention when both are compressed.
图2是本发明释放一个分支架的结构示意图。Fig. 2 is a structural schematic diagram of releasing a sub-stent in the present invention.
图3是本发明释放两个分支架的结构示意图。Fig. 3 is a structural schematic diagram of releasing two sub-stents according to the present invention.
图4是本发明释放三个分支架的结构示意图。Fig. 4 is a structural schematic diagram of releasing three sub-stents according to the present invention.
图5是本发明分支架、主支架均释放时的结构示意图。Fig. 5 is a schematic structural view of the sub-stent and the main stent of the present invention when both are released.
图6是本发明收紧绳A的结构示意图。Fig. 6 is a structural schematic diagram of the tightening rope A of the present invention.
图7是本发明收紧绳A与定位绳A的配合关系示意图。Fig. 7 is a schematic diagram of the cooperative relationship between the tightening rope A and the positioning rope A of the present invention.
图8是本发明收紧绳B的结构示意图。Fig. 8 is a structural schematic diagram of the tightening rope B of the present invention.
图9是本发明收紧绳B与定位绳B的配合关系示意图。Fig. 9 is a schematic diagram of the cooperative relationship between the tightening rope B and the positioning rope B of the present invention.
标号说明：1主支架、1-1覆膜、1-2波形环状物、2分支架、3收紧绳A、4定位绳A、5收紧绳B、6定位绳B、7固定孔A、8固定孔B。Explanation of symbols: 1 main bracket, 1-1 film, 1-2 wave ring, 2 branch bracket, 3 tightening rope A, 4 positioning rope A, 5 tightening rope B, 6 positioning rope B, 7 fixing hole A, 8 fixing holes B.
具体实施方式detailed description
下面结合说明书附图和实施例对本发明内容进行详细说明：The content of the present invention will be described in detail below in conjunction with the accompanying drawings and embodiments of the description:
如图1至图5所示：一种主动脉覆膜分支支架，它包括放于主动脉中的主支架1以及设于主支架1侧壁外侧并与主支架1联通的分支架2，所述的主支架1包括覆膜1-1以及支撑覆膜1-1的若干圈波形环状物1-2，其特征在于：波形环状物1-2的波距以及相邻波峰与波谷之间的距离由弓弧形的内侧向外侧逐渐递增，使得主支架1自然展开后的形状呈弓弧形，分支架2包括分支架覆膜以及支撑分支架覆膜的伸缩式弹簧结构，分支架2的底端与主支架1侧壁外侧连接，波形环状物1-2使得主支架1能够通过若干个收紧装置使主支架1收紧至口径缩小并维持收紧的状态；弹簧结构使分支架2能够通过一压缩装置使分支架压缩并维持压缩状态。As shown in Figures 1 to 5: an aortic covered branch stent, which includes a main stent 1 placed in the aorta and a sub-stent 2 that is located on the outside of the side wall of the main stent 1 and communicates with the main stent 1. The main stent 1 described above includes a membrane 1-1 and a number of wave-shaped rings 1-2 supporting the membrane 1-1, which are characterized in that: The distance between them is gradually increased from the inside to the outside of the arch, so that the shape of the main support 1 after natural expansion is arc-shaped. The sub-stent 2 includes the sub-stent coating and the telescopic spring structure supporting the sub-stent coating. The bottom end of 2 is connected to the outside of the side wall of the main bracket 1, and the wave-shaped ring 1-2 enables the main bracket 1 to tighten the main bracket 1 to a reduced diameter and maintain a tightened state through several tightening devices; the spring structure makes The sub-stent 2 can be compressed by a compression device and maintained in a compressed state.
所述的分支架为1至3个；波形环状物1-2的波距以及相邻波峰与波谷之间的距离由弓弧形的内侧向外侧逐渐递增，使得主支架1外侧的张力大于内侧的张力，从而使主支架1能够自然的弯成弓弧状，该主动脉覆膜分支支架因其主支架自身呈弓弧形，所以当其植入主动脉中时，不会因为要与主动脉的形状相适应而刻意弯曲成弓弧形，也就不会对主动脉带来压力，所以不会损伤主动脉。该主动脉覆膜分支支架在植入主动脉前，主支架处于收紧状态，分支架处于压缩状态如图1所示，主支架1通过若干个收紧装置收紧并定型，使主支架1保持收紧状态且主支架1的口径大小保持固定，而分支架2通过一压缩装置进行压缩并锁紧，使得分支架2保持压缩状态，这样的设计便于该主动脉覆膜分支支架顺利的植入主动脉中。There are 1 to 3 sub-stents; the wave distance of the wave-shaped ring 1-2 and the distance between adjacent peaks and troughs gradually increase from the inside to the outside of the arc, so that the tension on the outside of the main support 1 is greater than The tension on the inner side makes the main stent 1 naturally bend into an arc shape. Because the main stent itself is arc-shaped, the aortic covered branch stent will not be in contact with the aorta when it is implanted in the aorta. The shape of the artery is adapted to the shape and deliberately bent into an arc, so that it will not put pressure on the aorta, so it will not damage the aorta. Before the aortic covered branch stent is implanted into the aorta, the main stent is in a tightened state, and the sub-stents are in a compressed state as shown in Figure 1. The main stent 1 is tightened and shaped by several tightening devices, so that the main stent 1 Keep the tightened state and the caliber of the main stent 1 remains fixed, and the sub-stent 2 is compressed and locked by a compression device, so that the sub-stent 2 remains in a compressed state. This design facilitates the smooth implantation of the aortic covered branch stent into the aorta.
所述的收紧装置包括收紧绳A3以及定位绳A4，所述收紧绳A3的前、后两段设有若干个固定孔A7，所述收紧绳A3与定位绳A4的配合关系为：收紧绳A3绕设于收紧的主支架1的外周，使得位于收紧绳A3前段上的某个固定孔A7与收紧绳A3后段上的某个固定孔A7相互重叠，定位绳A4穿过这两个固定孔A7，使主支架1维持收紧的状态。The tightening device includes a tightening rope A3 and a positioning rope A4, the front and rear sections of the tightening rope A3 are provided with several fixing holes A7, and the matching relationship between the tightening rope A3 and the positioning rope A4 is as follows: : The tightening rope A3 is wound around the outer circumference of the tightened main bracket 1, so that a certain fixing hole A7 on the front section of the tightening rope A3 overlaps with a certain fixing hole A7 on the rear section of the tightening rope A3, and the positioning rope A4 passes through the two fixing holes A7 to keep the main bracket 1 in a tightened state.
通过收紧收紧绳A3，并由定位绳A4固定收紧绳A3的收紧程度，使得主支架口径缩小并维持收紧的状态，使得主支架能够与主动脉相适应，在植入主动脉前，主支架的口径可以通过收紧绳A3与定位绳A4相互配合锁紧到最小的状态如图1所示，这样方便该主动脉覆膜分支支架的植入，待该主动脉覆膜分支支架植入到主动脉中的合适位置时，抽走定位绳A4，此时收紧绳A3被释放，相应的主支架被释放如图5所示，所以本发明符合人体解剖学主动脉弓部特点，可以适合不同的个体，可以最大程度满足个体差异，且本发明通过收紧绳A3与定位绳A4的相互配合来收紧或释放主支架，使得医生在收紧或释放主支架时，操作更加便捷迅速，大大节约了手术时间。By tightening the tightening rope A3, and fixing the tightening degree of the tightening rope A3 by the positioning rope A4, the caliber of the main stent is reduced and the state of tightening is maintained, so that the main stent can be adapted to the aorta. Before, the caliber of the main stent can be locked to the minimum state by cooperating with the tightening rope A3 and the positioning rope A4, as shown in Figure 1, which facilitates the implantation of the aortic graft branch stent. When the stent is implanted at a suitable position in the aorta, the positioning rope A4 is pulled away, and the tightening rope A3 is released at this time, and the corresponding main stent is released as shown in Figure 5, so the present invention conforms to the characteristics of the aortic arch in human anatomy. It can be suitable for different individuals, and can meet individual differences to the greatest extent, and the present invention tightens or releases the main bracket through the mutual cooperation of the tightening rope A3 and the positioning rope A4, so that the doctor can operate more conveniently when tightening or releasing the main bracket Fast, greatly saving operation time.
所述的压缩装置包括收紧绳B5以及定位绳B6，所述收紧绳B5的前、后两段设有若干个固定孔B8，所述收紧绳B5与定位绳B6的配合关系为：先将分支架2压缩，收紧绳B5绕过压缩的分支架2，并经过收紧的主支架1，使得位于收紧绳B5前段上的某个固定孔B8与收紧绳B5后段上的某个固定孔B8相互重叠，定位绳B6穿过这两个固定孔B8，使分支架2保持压缩状态。The compression device includes a tightening rope B5 and a positioning rope B6, the front and rear sections of the tightening rope B5 are provided with several fixing holes B8, and the cooperative relationship between the tightening rope B5 and the positioning rope B6 is as follows: First compress the sub-bracket 2, the tightening rope B5 bypasses the compressed sub-support 2, and passes through the tightened main bracket 1, so that a certain fixing hole B8 on the front section of the tightening rope B5 is connected to the rear section of the tightening rope B5. Some of the fixing holes B8 overlap each other, and the positioning rope B6 passes through these two fixing holes B8, so that the sub-bracket 2 remains in a compressed state.
当该主动脉覆膜分支支架植入主动脉中过程中，起初分支架2在压缩装置的作用下处于压缩状态如图1所示，分支架和主支架均处于缩紧状态便于主支架植入主动脉，当分支架即将靠近主动脉的分血管如无名动脉时，抽走定位绳B6，此时收紧绳B5被释放，相应的分支架也被释放，如图2至4所示，因分支架已经临近分血管，且分支架处于释放状态，所以分支架能够更好的与分支架对应的血管对准，仅需再微调、转动主支架，便可以将分支架准确定位于分支血管中，有效的防止了分支架定位不良从而发生扭曲、折叠，堵塞血管。When the aortic covered branch stent is implanted in the aorta, the initial branch stent 2 is in a compressed state under the action of the compression device as shown in Figure 1, and both the branch stent and the main stent are in a tightened state to facilitate the implantation of the main stent Aorta, when the sub-stent is about to be close to the sub-vessel of the aorta such as the innominate artery, the positioning rope B6 is pulled away, and the tightening rope B5 is released at this time, and the corresponding sub-stent is also released, as shown in Figures 2 to 4. The stent is already close to the sub-vessel, and the sub-stent is in the released state, so the sub-stent can be better aligned with the corresponding vessel of the sub-stent, and the sub-stent can be accurately positioned in the branch vessel only by fine-tuning and rotating the main stent. It effectively prevents the sub-stent from being twisted, folded, and blocked blood vessels due to poor positioning.
如图6、7所示：收紧绳A3和定位绳A4的配合关系；如图8、9所示：收紧绳B5和定位绳B6的配合关系。As shown in Figures 6 and 7: the coordination relationship between the tightening rope A3 and the positioning rope A4; as shown in Figures 8 and 9: the coordination relationship between the tightening rope B5 and the positioning rope B6.
本发明的主动脉覆膜分支支架的使用方式如下：本主动脉覆膜分支支架在使用前，主支架在收紧装置的作用下，主支架的口径处于锁紧在最小的状态，同时分支架在压缩装置的作用下处于压缩状态，将压缩状态的主动脉覆膜分支支架装载入包含调节杆的输送装置中，用输送装置把主动脉覆膜分支支架送入到主动脉中，当分支架对位于相应的分支血管时，抽走定位绳B6,此时收紧绳B5被释放，相应的分支架也被释放，这个时候，分支架的端头基本对齐或者已经突入相对应的血管，接着通过控制植入调节杆调整分支架的位置，使得分支架的端头进一步对准相对应的血管，如图4所示，之后再通过释放主支架上的收紧装置来释放主支架如图5所示，这个时候，主支架的展开，将分支架进一步送入相对应的血管中，最后再移除输送装置即可。The usage of the aortic covered branch stent of the present invention is as follows: before using the aortic covered branch stent, the main stent is under the action of the tightening device, and the caliber of the main stent is locked in the minimum state, and at the same time, the sub-stent Under the action of the compression device, it is in a compressed state, and the compressed aortic covered branch stent is loaded into the delivery device containing the adjustment rod, and the aortic covered branch stent is sent into the aorta with the delivery device. When the corresponding branch blood vessel is located, the positioning rope B6 is pulled away, and the tightening rope B5 is released at this time, and the corresponding sub-stent is also released. At this time, the ends of the sub-stent are basically aligned or have broken into the corresponding blood vessel, and then Adjust the position of the sub-stent by controlling the implant adjustment rod, so that the end of the sub-stent is further aligned with the corresponding blood vessel, as shown in Figure 4, and then release the main stent by releasing the tightening device on the main stent as shown in Figure 5 As shown, at this time, the deployment of the main stent will further send the sub-stent into the corresponding blood vessel, and finally remove the delivery device.
在释放过程中，分支架与主支架的释放顺序是不可以颠倒的，先抽走定位绳B6，能够使分支架更好的对准与分支架相对应的血管，因为这个时候主支架处于收紧状态，使得该主动脉覆膜分支支架能够在植入调节杆的控制下任意转动、移动，当释放后的分支架一旦对准相对应的血管的管口，这个时候释放主支架，就能保证分支架100％的进入相对应的管道。如果先释放主支架，此时再来移动、旋转该主动脉覆膜分支支架将变得不易，则不利于分支管进入分血管中。During the release process, the release sequence of the sub-stent and the main stent cannot be reversed. The positioning rope B6 can be pulled away first, so that the sub-stent can be better aligned with the blood vessel corresponding to the sub-stent, because the main stent is in the retracted position at this time. Tight state, so that the aortic covered branch stent can rotate and move arbitrarily under the control of the implanted adjustment rod. Once the released sub-stent is aligned with the orifice of the corresponding blood vessel, the main stent can be released at this time. Ensure that 100% of the sub-stents enter the corresponding pipes. If the main stent is released first, it will be difficult to move and rotate the aortic covered branch stent at this time, which is not conducive to the entry of the branch tube into the branch blood vessel.
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610300430.4ACN105726165B (en) | 2016-05-09 | 2016-05-09 | A kind of aortic covered branch stent |
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610300430.4ACN105726165B (en) | 2016-05-09 | 2016-05-09 | A kind of aortic covered branch stent |
| Publication Number | Publication Date |
|---|---|
| CN105726165Atrue CN105726165A (en) | 2016-07-06 |
| CN105726165B CN105726165B (en) | 2017-07-28 |
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201610300430.4AActiveCN105726165B (en) | 2016-05-09 | 2016-05-09 | A kind of aortic covered branch stent |
| Country | Link |
|---|---|
| CN (1) | CN105726165B (en) |
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