CN117860332A - Aortic dissection progress blocking device - Google Patents
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Abstract
本发明涉及医疗器械领域,具体公开了一种主动脉夹层进展阻断装置,包括:一介入导管,用于以介入方式进入主动脉内;若干导向导管,沿所述介入导管内腔进入主动脉内,各所述导向导管的管头沿周向分布并以弹性连接件依次相连接,所述弹性连接件使得各所述导向导管的管头从介入导管的端口伸出后沿径向展开至与主动脉内壁接触;若干穿刺导丝,沿相应的所述导向导管内腔行进并从导向导管的管头伸出后刺破主动脉形成造孔;以及若干封堵器,沿相应的穿刺导丝行进并于主动脉内外侧封堵造孔同时夹紧主动脉。本发明能够以介入方式阻断主动脉夹层的进展,从而稳定病况,为外科手术治疗争取时间。
The present invention relates to the field of medical devices, and specifically discloses a device for blocking the progression of aortic dissection, comprising: an interventional catheter for entering the aorta in an interventional manner; a plurality of guide catheters, which enter the aorta along the inner cavity of the interventional catheter, the tube heads of each of the guide catheters are distributed circumferentially and are connected in sequence by elastic connectors, and the elastic connectors enable the tube heads of each of the guide catheters to extend from the port of the interventional catheter and then expand radially to contact the inner wall of the aorta; a plurality of puncture guidewires, which travel along the corresponding inner cavity of the guide catheter and extend from the tube head of the guide catheter to puncture the aorta to form a pore; and a plurality of occluders, which travel along the corresponding puncture guidewires and block the pore inside and outside the aorta while clamping the aorta. The present invention can block the progression of aortic dissection in an interventional manner, thereby stabilizing the condition and buying time for surgical treatment.
Description
技术领域Technical Field
本发明涉及医疗器械领域,尤其涉及一种主动脉夹层进展阻断装置。The present invention relates to the field of medical devices, and in particular to a device for blocking the progression of aortic dissection.
背景技术Background technique
主动脉夹层(Aortic Dissection,AD),是指在各种因素作用下,主动脉内膜破裂形成破口,血管中的血液通过主动脉内膜裂口进入薄弱的主动脉壁中层,伴或不伴中层纵行撕裂,正常动脉壁分离,最终在动脉壁形成假腔,造成血流动力学障碍,进而危及生命的疾病。主动脉夹层是一种致死性的急危重症,其起病急骤,可在短期内造成主动脉破裂而导致休克并迅速造成死亡,或因远端重要脏器缺血而引起严重的并发症。因此,AD的发病机制及治疗研究一直是血管疾病研究领域的热点。Aortic dissection (AD) refers to a disease in which the aortic intima ruptures under the influence of various factors, forming a tear. The blood in the blood vessels enters the weak middle layer of the aortic wall through the tear in the aortic intima, with or without longitudinal tearing of the middle layer, and the normal arterial wall separates, eventually forming a false lumen in the arterial wall, causing hemodynamic disorders and thus endangering life. Aortic dissection is a fatal, critical disease with an acute onset. It can cause aortic rupture in a short period of time, leading to shock and rapid death, or cause serious complications due to ischemia of distal important organs. Therefore, the pathogenesis and treatment of AD have always been a hot topic in the field of vascular disease research.
临床实践中,根据患者主动脉夹层的位置,可分为A型和B型;A型夹层涉及心脏相连的主动脉,它的血压最高,最容易破裂;目前A型夹层的唯一治疗方法是急诊开胸手术,用人造血管代替与心脏相连的主动脉;B型夹层,主动脉夹层仅限于胸腹部的主动脉,可采用介入支架或药物保守治疗。In clinical practice, aortic dissection can be divided into type A and type B according to the location of the patient's aortic dissection; type A dissection involves the aorta connected to the heart, which has the highest blood pressure and is most likely to rupture; currently the only treatment for type A dissection is emergency thoracotomy, replacing the aorta connected to the heart with an artificial blood vessel; type B dissection, in which the aortic dissection is limited to the aorta in the chest and abdomen, can be treated conservatively with interventional stents or drugs.
主动脉夹层疾病凶险,进展迅速,部分患者在到达医院前即死亡;主动脉夹层进展时,血液通过破口进入假腔,随着压力增大,假腔沿着血管不断进展,假腔进展的越大,破裂风险和脏器影响越大。由于夹层是时刻进展中的,临床中常有A型夹层患者无法施行急诊手术或者手术等待期较长,或者B型夹层在进展后逆撕为A型夹层,而据本发明创造的发明人了解,国内外的现有技术中并不具备能够阻断夹层进展的装置,往往只能任由进展的发生,这对患者而言是极其危险的。Aortic dissection is a dangerous disease that progresses rapidly. Some patients die before reaching the hospital. When aortic dissection progresses, blood enters the false lumen through the rupture. As the pressure increases, the false lumen continues to progress along the blood vessels. The greater the false lumen progresses, the greater the risk of rupture and organ impact. Because the dissection is constantly progressing, it is common in clinical practice that patients with type A dissection cannot undergo emergency surgery or have a long waiting period for surgery, or type B dissection reverses to type A dissection after progression. According to the inventors of the present invention, the existing technologies at home and abroad do not have devices that can block the progression of dissection, and often can only allow the progression to occur, which is extremely dangerous for patients.
因此,为解决上述问题,就需要一种主动脉夹层进展阻断装置。Therefore, in order to solve the above problems, a device for blocking the progression of aortic dissection is needed.
发明内容Summary of the invention
有鉴于此,本发明的目的在于提供一种主动脉夹层进展阻断装置,能够以介入方式阻断主动脉夹层的进展,从而稳定病况,为外科手术治疗争取时间。In view of this, an object of the present invention is to provide a device for blocking the progression of aortic dissection, which can block the progression of aortic dissection in an interventional manner, thereby stabilizing the condition and buying time for surgical treatment.
为了实现上述目的,本发明特提供了一种主动脉夹层进展阻断装置,包括:In order to achieve the above-mentioned object, the present invention provides a device for blocking the progression of aortic dissection, comprising:
一介入导管,用于以介入方式进入主动脉内;An interventional catheter, used to enter the aorta in an interventional manner;
若干导向导管,沿所述介入导管内腔进入主动脉内,各所述导向导管的管头沿周向分布并以弹性连接件依次相连接,所述弹性连接件使得各所述导向导管的管头从介入导管的端口伸出后沿径向展开至与主动脉内壁接触;A plurality of guide catheters are inserted into the aorta along the inner cavity of the interventional catheter, the tube heads of the guide catheters are distributed along the circumferential direction and are sequentially connected by elastic connectors, and the elastic connectors enable the tube heads of the guide catheters to extend from the ports of the interventional catheters and then expand radially to contact the inner wall of the aorta;
若干穿刺导丝,沿相应的所述导向导管内腔行进并从导向导管的管头伸出后刺破主动脉形成造孔;以及A plurality of puncture guide wires are arranged along the inner lumens of the corresponding guide catheters and extended from the tube heads of the guide catheters to puncture the aorta to form a puncture; and
若干封堵器,沿相应的穿刺导丝行进并于主动脉内外侧封堵造孔同时夹紧主动脉。Several occluders are advanced along corresponding puncture guidewires to block holes inside and outside the aorta while clamping the aorta.
作为对上述技术方案的进一步改进,所述导向导管的数量为3~8个,所述穿刺导丝及封堵器的数量与导向导管的数量相同。As a further improvement to the above technical solution, the number of the guide catheters is 3 to 8, and the number of the puncture guidewires and the occluders is the same as the number of the guide catheters.
作为对上述技术方案的进一步改进,所述弹性连接件为弧形弹片或者压缩弹簧。As a further improvement to the above technical solution, the elastic connecting member is an arc-shaped spring or a compression spring.
作为对上述技术方案的进一步改进,所述导向导管的管头置于介入导管内腔时弹性连接件呈压缩状态。As a further improvement to the above technical solution, when the tube head of the guide catheter is placed in the inner cavity of the interventional catheter, the elastic connector is in a compressed state.
作为对上述技术方案的进一步改进,各所述导向导管的管头沿周向均匀分布。As a further improvement to the above technical solution, the tube heads of the guide catheters are evenly distributed along the circumferential direction.
作为对上述技术方案的进一步改进,所述导向导管的头端为尖端结构。As a further improvement to the above technical solution, the tip end of the guide catheter is a tip structure.
作为对上述技术方案的进一步改进,所述封堵器包括弹性网支架和密封膜,所述弹性网支架支架包括由镍钛合金丝编织一体成型制成的左盘、腰部和右盘,所述密封膜设于左盘和右盘内部。As a further improvement of the above technical solution, the occluder includes an elastic mesh support and a sealing membrane. The elastic mesh support includes a left disc, a waist and a right disc made of nickel-titanium alloy wire woven into one piece. The sealing membrane is arranged inside the left disc and the right disc.
与现有技术相比,本发明具有以下有益技术效果:Compared with the prior art, the present invention has the following beneficial technical effects:
本发明提供的一种主动脉夹层进展阻断装置,使用时,介入导管通过介入方式进入主动脉并到达夹层假腔进展方向的远端正常血管位置,然后各导向导管的管头从其端口伸出并朝向主动脉内壁伸展,导向导管展开后再伸出穿刺导丝,刺破管壁形成造孔,再将封堵器封堵造孔同时夹紧主动脉,由此形成一周由多个封堵器形成的环型带,这个环型带把正常主动脉壁的外膜中膜内膜压紧,使得夹层进展时,假腔进展到这里,无法继续进展;The present invention provides an aortic dissection progression blocking device. When in use, an interventional catheter enters the aorta in an interventional manner and reaches the distal normal blood vessel position in the progression direction of the dissection false lumen. Then, the tube heads of each guide catheter extend from its port and extend toward the inner wall of the aorta. After the guide catheter is unfolded, a puncture guide wire is extended to puncture the tube wall to form a pore. Then, an occluder is used to block the pore and clamp the aorta at the same time, thereby forming a ring-shaped band formed by multiple occluders. This ring-shaped band presses the outer membrane, the middle membrane and the inner membrane of the normal aortic wall, so that when the dissection progresses, the false lumen progresses to this point and cannot continue to progress.
因此,通过本发明提供的一种主动脉夹层进展阻断装置,能够以介入方式阻断主动脉夹层的进展,从而稳定病况,为外科手术治疗争取时间;本发明符合社会需要,具有很强的实用性,有利于推动心血管医疗技术的进一步发展。Therefore, the aortic dissection progression blocking device provided by the present invention can block the progression of aortic dissection in an interventional manner, thereby stabilizing the condition and buying time for surgical treatment; the present invention meets social needs, has strong practicality, and is conducive to promoting the further development of cardiovascular medical technology.
本发明附加方面的优点将在下面的描述中部分给出,部分将从下面的描述中变得明显,或通过本发明的实践了解到。Advantages of additional aspects of the present invention will be given in part in the following description, and in part will become obvious from the following description, or will be learned through practice of the present invention.
附图说明BRIEF DESCRIPTION OF THE DRAWINGS
构成本发明的一部分的说明书附图用来提供对本发明的进一步理解,本发明的示意性实施例及其说明用于解释本发明,并不构成对本发明的限定。The accompanying drawings constituting a part of the present invention are used to provide a further understanding of the present invention. The exemplary embodiments of the present invention and their description are used to explain the present invention but do not constitute a limitation of the present invention.
图1为本发明的结构示意图;Fig. 1 is a schematic diagram of the structure of the present invention;
图2为本发明的使用状态图;Fig. 2 is a diagram showing a state of use of the present invention;
图3为使用本发明进行阻断后的主动脉效果图。FIG. 3 is a diagram showing the effect of the aorta after being blocked using the present invention.
具体实施方式Detailed ways
为使本领域技术人员更好地理解本发明的技术方案,下面结合附图和具体实施例对本发明作进一步的详细说明;当然,附图为简化后的示意图,其比例大小并不构成对专利产品的限制。In order to enable those skilled in the art to better understand the technical solution of the present invention, the present invention is further described in detail below in conjunction with the accompanying drawings and specific embodiments; of course, the accompanying drawings are simplified schematic diagrams, and their proportional sizes do not constitute a limitation on the patented product.
实施例Example
如图1至图3所示:本实施例提供了一种主动脉夹层进展阻断装置,包括一介入导管1、若干导向导管2、若干穿刺导丝3以及若干封堵器4。As shown in FIGS. 1 to 3 : This embodiment provides a device for blocking the progression of aortic dissection, comprising an interventional catheter 1 , a plurality of guide catheters 2 , a plurality of puncture guidewires 3 and a plurality of occluders 4 .
其中,介入导管1用于以介入方式进入主动脉9内;介入治疗的方式为心血管医疗领域的医师所熟知,在此不再赘述。The interventional catheter 1 is used to enter the aorta 9 in an interventional manner. The interventional treatment method is well known to physicians in the field of cardiovascular medicine and will not be described in detail here.
若干导向导管2沿所述介入导管1内腔进入主动脉9内,各所述导向导管2的管头沿周向分布并以弹性连接件5依次相连接,所述弹性连接件5使得各所述导向导管2的管头从介入导管1的端口伸出后沿径向展开至与主动脉9内壁接触;导向导管2的管头为深入主动脉9(远离体外操作端)的一端;导向导管2的数量可根据需要而定,例如导向导管2的数量可为3~8个,穿刺导丝3及封堵器4的数量与导向导管2的数量相同。A plurality of guide catheters 2 enter the aorta 9 along the inner cavity of the interventional catheter 1, and the tube heads of the guide catheters 2 are distributed along the circumferential direction and are connected in sequence with elastic connectors 5. The elastic connectors 5 enable the tube heads of the guide catheters 2 to extend from the ports of the interventional catheters 1 and then expand radially until they contact the inner wall of the aorta 9; the tube head of the guide catheter 2 is the end that penetrates deep into the aorta 9 (away from the in vitro operating end); the number of guide catheters 2 can be determined according to needs, for example, the number of guide catheters 2 can be 3 to 8, and the number of puncture guidewires 3 and occluders 4 is the same as the number of guide catheters 2.
作为优选,各所述导向导管2的管头沿周向均匀分布,此时各导向导管2的头端处于同一平面,相邻管头之间具有相同的夹角;导向导管2的管头在展开后所在圆周的直径大于介入导管1的直径;导向导管2的管头置于介入导管1内腔时弹性连接件5呈压缩状态(部分压缩或者全部压缩),此时的导向导管2与介入导管1内壁之间具有一定的相对压力,使得导向导管2可随介入导管1一同移动;弹性连接件5可以为弧形弹片或者压缩弹簧;此外,导向导管2的头端可为尖端结构,以便于其定位在主动脉9内壁。Preferably, the tube heads of each of the guide catheters 2 are evenly distributed along the circumference, and the head ends of each guide catheter 2 are in the same plane, and adjacent tube heads have the same angle; the diameter of the circle where the tube heads of the guide catheters 2 are located after being unfolded is larger than the diameter of the interventional catheter 1; when the tube head of the guide catheter 2 is placed in the inner cavity of the interventional catheter 1, the elastic connector 5 is in a compressed state (partially compressed or fully compressed), and at this time there is a certain relative pressure between the guide catheter 2 and the inner wall of the interventional catheter 1, so that the guide catheter 2 can move with the interventional catheter 1; the elastic connector 5 can be an arc-shaped spring or a compression spring; in addition, the head end of the guide catheter 2 can be a pointed structure to facilitate its positioning on the inner wall of the aorta 9.
若干穿刺导丝3沿相应的所述导向导管2内腔行进并从导向导管2的管头伸出后刺破主动脉9形成造孔8;穿刺导丝3可为具备弹性的金属丝,能够刺破主动脉9壁并能够起到介入操作时的引导作用。A plurality of puncture guidewires 3 travel along the corresponding inner cavity of the guide catheter 2 and extend from the tube head of the guide catheter 2 to puncture the aorta 9 to form a pore 8; the puncture guidewires 3 can be elastic metal wires that can puncture the wall of the aorta 9 and can play a guiding role during interventional operations.
若干封堵器4沿相应的穿刺导丝3行进并于主动脉9内外侧封堵造孔8同时夹紧主动脉9;封堵器4在结构和原理上与现有的心脏缺损封堵器4是相同的,只是在尺寸上更为微小,以适应主动脉9的放置需求;例如,封堵器4可包括弹性网支架和密封膜(图中未示出),所述弹性网支架支架包括由镍钛合金丝编织一体成型制成的左盘41、腰部42和右盘43,所述密封膜设于左盘41和右盘43内部。A number of occluders 4 travel along the corresponding puncture guide wires 3 and block the pores 8 on the inside and outside of the aorta 9 while clamping the aorta 9; the occluders 4 are the same as the existing heart defect occluders 4 in structure and principle, but are smaller in size to meet the placement requirements of the aorta 9; for example, the occluder 4 may include an elastic mesh support and a sealing membrane (not shown in the figure), the elastic mesh support includes a left disc 41, a waist 42 and a right disc 43 made of nickel-titanium alloy wire woven into one piece, and the sealing membrane is arranged inside the left disc 41 and the right disc 43.
现有的心脏缺损封堵器4被用来治疗先天性心脏间隔缺损,缺损的间隔壁被封堵器4的左、右两个网架夹住,使缺损闭合,达到临床治愈的目的,例如可见专利CN205903284U、CN219763408U等;而本实施例则创造性地利用了封堵器4的穿孔及夹紧特性,以人工穿孔的方式配合多个封堵器4将主动脉9壁夹紧,由此阻断主动脉9夹层的进展。封堵器4的介入操作为本领域技术人员所熟知,一般可使用输送鞘5,在此也不再赘述。The existing heart defect occluder 4 is used to treat congenital heart septal defect. The septal wall of the defect is clamped by the left and right mesh frames of the occluder 4 to close the defect and achieve the purpose of clinical cure. For example, patents CN205903284U and CN219763408U can be seen; while this embodiment creatively utilizes the perforation and clamping characteristics of the occluder 4, and clamps the aorta 9 wall in an artificial perforation manner with multiple occluders 4, thereby blocking the progression of aortic dissection 9. The interventional operation of the occluder 4 is well known to those skilled in the art, and a delivery sheath 5 can generally be used, which will not be repeated here.
具体而言,在使用时,介入导管1通过介入方式进入主动脉9,通过DSA(数字减影血管造影技术)确定到达夹层进展附近,找到夹层假腔进展方向的远端正常主动脉9位置,介入导管1内部伸出多个导向导管2,在弹性连接件5放松的情况下形成类似于伞状的结构,导向导管2尖端可朝向主动脉9内壁紧抵在主动脉9内壁,从导向导管2内部伸出穿刺导丝3,穿刺导丝3刺破主动脉9壁,随着穿刺导丝3,每个穿刺导丝3可伸入一个小型的封堵器4(多个封堵器4同时进行可减少出血,每个封堵器4逐个使用则进行可调整相互位置,使得封堵更为确切,具体操作根据客观情况),最后在正常主动脉9的一周,形成一周由多个封堵器4形成的环型带,这个环型带把正常主动脉9壁的外膜、中膜、内膜同时压紧,使得夹层进展时,假腔7进展到这一位置则无法继续进展;本实施例对的装置尤其适用于防止B型夹层逆撕为A型夹层,同时也可以为B型夹层支架置入提供了铆钉点。Specifically, when in use, the interventional catheter 1 enters the aorta 9 in an interventional manner, and DSA (digital subtraction angiography) is used to determine that it has reached the vicinity of the dissection progression, and the distal normal aorta 9 position in the direction of the dissection false lumen progression is found. A plurality of guide catheters 2 are extended from the interventional catheter 1, and when the elastic connector 5 is relaxed, an umbrella-like structure is formed. The tip of the guide catheter 2 can be pressed against the inner wall of the aorta 9, and a puncture guide wire 3 is extended from the guide catheter 2. The puncture guide wire 3 punctures the aorta 9 wall. As the puncture guide wire 3 is extended, each puncture guide wire 3 can be extended into a small The occluder 4 is used (multiple occluders 4 can reduce bleeding at the same time, and each occluder 4 can adjust its relative position when used one by one to make the occlusion more accurate. The specific operation depends on the objective situation). Finally, an annular belt formed by multiple occluders 4 is formed around the normal aorta 9. This annular belt presses the outer membrane, middle membrane and inner membrane of the wall of the normal aorta 9 at the same time, so that when the dissection progresses, the false lumen 7 progresses to this position and cannot continue to progress. The device of this embodiment is particularly suitable for preventing type B dissection from being torn into type A dissection, and can also provide rivet points for the implantation of type B dissection stents.
最后说明的是,本文应用了具体个例对本发明的原理及实施方式进行了阐述,以上实施例的说明只是用于帮助理解本发明的核心思想,在不脱离本发明原理的情况下,还可对本发明进行若干改进和修饰,这些改进和修饰也落入本发明的保护范围内。Finally, it should be noted that this article uses specific examples to illustrate the principles and implementation methods of the present invention. The description of the above embodiments is only to help understand the core idea of the present invention. Without departing from the principles of the present invention, the present invention may be further improved and modified, and these improvements and modifications also fall within the scope of protection of the present invention.
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