CN115998361A - Heart treatment device - Google Patents
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- CN115998361A CN115998361A CN202310120724.9A CN202310120724A CN115998361A CN 115998361 A CN115998361 A CN 115998361A CN 202310120724 A CN202310120724 A CN 202310120724A CN 115998361 A CN115998361 A CN 115998361A
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Abstract
Description
技术领域technical field
本发明涉及医疗器械技术领域,特别是涉及一种用于封堵左心耳的心脏治疗装置。The invention relates to the technical field of medical devices, in particular to a heart treatment device for blocking the left atrial appendage.
背景技术Background technique
心房颤动,简称房颤,是最常见的心律失常之一。房颤最大的风险在于易导致栓塞事件,如急性脑梗死、急性心肌梗死,房颤高危栓塞患者需积极抗凝治疗,而药物抗凝治疗有导致包括脑出血在内的出血风险,左心耳封堵术通过介入手术的方式应用国产或进口封堵器堵塞左心耳,预防房颤时左心耳(LAA)血栓的形成,可达到药物抗凝的治疗效果,降低房颤患者由血栓栓塞引发长期残疾或死亡的风险,而出血风险大大降低。因此,左心耳封堵术可消除患者对长期口服抗凝治疗的依赖性,为不能长期接受抗凝治疗、不愿药物抗凝治疗以及出血高风险的患者提供新的治疗选择。Atrial fibrillation, or atrial fibrillation for short, is one of the most common heart rhythm disorders. The biggest risk of atrial fibrillation is that it is prone to lead to embolism events, such as acute cerebral infarction and acute myocardial infarction. Patients with high risk of embolism in atrial fibrillation need active anticoagulant therapy, and drug anticoagulant therapy has the risk of bleeding including cerebral hemorrhage. Left atrial appendage seal The occlusion operation uses domestic or imported occluders to block the left atrial appendage through interventional surgery to prevent the formation of left atrial appendage (LAA) thrombus during atrial fibrillation, which can achieve the therapeutic effect of drug anticoagulation and reduce long-term disability caused by thromboembolism in patients with atrial fibrillation. or death, while the risk of bleeding is greatly reduced. Therefore, left atrial appendage closure can eliminate the dependence of patients on long-term oral anticoagulant therapy, and provide a new treatment option for patients who cannot receive anticoagulant therapy for a long time, who are unwilling to take drug anticoagulant therapy, and who are at high risk of bleeding.
现有技术中的封堵器通常将封堵伞送入左心耳开口处,将左心耳开口完全封闭,在封堵伞后方设计封堵盘将左心耳壁撑起,从而起到固定封堵伞的作用,现有技术中的伞盘结构为金属网材质,封堵伞外表面均需要有倒刺,上述结构存在诸多弊端:1、对心耳的形态有严格的要求,很多患者因为心耳分叶不规则、心耳深度不够等原因导致封堵失败或封堵不完全。2、现有封堵器为了减少封堵器脱落,多在封堵器上设计有倒刺,在封堵器释放后,倒刺插入左房壁内,起到稳定作用,但是由于倒刺插入深度及方向不可控,极易造成穿透房壁,造成心包积液。3、现有封堵器均以大面积的镍钛合金骨架接触流动血液,为了防止血栓,术后必须大量应用抗凝药物半年之久,而接受左心耳封堵治疗的患者恰恰是合并抗凝禁忌或者抗凝效果不佳的患者。4、现有的左心耳封堵器容易造成术后分流遗漏,贴壁性较差,密封度不高,容易带来术后隐患。The occluder in the prior art usually sends the occluder umbrella into the opening of the left atrial appendage to completely close the opening of the left atrial appendage, and a occluder plate is designed behind the occluder umbrella to prop up the wall of the left atrial appendage, thereby fixing the occluder umbrella. The structure of the umbrella disc in the prior art is made of metal mesh, and the outer surface of the blocking umbrella needs to have barbs. The above structure has many disadvantages: 1. There are strict requirements on the shape of the auricle, and many patients have lobed auricles. Irregularity, insufficient auricle depth and other reasons lead to closure failure or incomplete closure. 2. In order to reduce the falling off of the occluder, most of the existing occluders are designed with barbs on the occluder. After the occluder is released, the barbs are inserted into the left atrial wall to play a stabilizing role. However, due to the insertion of the barbs The depth and direction are uncontrollable, and it is very easy to penetrate the atrial wall and cause pericardial effusion. 3. Existing occluders use a large area of nickel-titanium alloy framework to contact the flowing blood. In order to prevent thrombus, a large number of anticoagulant drugs must be used for half a year after surgery, and patients receiving left atrial appendage occlusion are precisely combined with anticoagulation. Patients with contraindications or poor anticoagulant effect. 4. The existing left atrial appendage occluder is likely to cause postoperative shunt omission, poor adherence, and low sealing degree, which may easily cause postoperative hidden dangers.
发明内容Contents of the invention
有鉴于此,本发明的目的在于提供一种用于封堵左心耳的心脏治疗装置,旨在解决心脏治疗装置的韧性不高,贴壁性不强,支撑力不够的问题。In view of this, the purpose of the present invention is to provide a heart treatment device for occluding the left atrial appendage, aiming at solving the problems of the heart treatment device having low toughness, weak wall-attachment and insufficient supporting force.
本发明提供一种心脏治疗装置,用于封堵左心耳,包括膨胀件以及与所述膨胀件可拆卸地固定的配合件,所述膨胀件通过所述配合件将所述左心耳固定;所述膨胀件呈中空结构,所述膨胀件包括相互叠设的第一薄膜和第二薄膜,所述第一薄膜和所述第二薄膜之间设有支撑件,所述膨胀件包括第一膨胀区和第二膨胀区,所述支撑件至少设于所述第二膨胀区。The present invention provides a cardiac treatment device for occluding the left atrial appendage, comprising an expansion element and a fitting detachably fixed to the expansion element, the expansion element fixes the left atrial appendage through the fitting element; The expansion member has a hollow structure, the expansion member includes a first film and a second film stacked on top of each other, a support member is provided between the first film and the second film, and the expansion member includes a first expansion film zone and a second expansion zone, the support member is provided at least in the second expansion zone.
在一实施例中,所述支撑件设于所述第二膨胀区,所述支撑件的弹性模量小于所述膨胀件的弹性模量。In one embodiment, the supporting element is disposed in the second expansion region, and the modulus of elasticity of the supporting element is smaller than that of the expanding element.
在一实施例中,所述支撑件包括设于所述第一膨胀区的第一支撑部和设于所述第二膨胀区的第二支撑部,所述支撑件中至少所述第一支撑部的弹性模量大于所述膨胀件的弹性模量。In one embodiment, the support member includes a first support portion disposed in the first expansion area and a second support portion disposed in the second expansion area, and at least the first support portion in the support The elastic modulus of the part is greater than the elastic modulus of the expansion part.
在一实施例中,所述第一支撑部的弹性模量大于所述第二支撑部的弹性模量。In one embodiment, the modulus of elasticity of the first supporting part is greater than that of the second supporting part.
在一实施例中,所述支撑件包括至少一层支撑网,所述第一支撑部的网格密度大于或等于所述第二支撑部的网格密度,和/或,所述第一支撑部的所述支撑网的数量大于所述第二支撑部的所述支撑网的数量。In one embodiment, the support includes at least one layer of support net, the grid density of the first support part is greater than or equal to the grid density of the second support part, and/or, the first support The number of the support nets of the first support part is greater than the number of the support nets of the second support part.
在一实施例中,所述膨胀件的内部设有用于将膨胀件与配合件相对固定的介入部。In one embodiment, an intervening portion for relatively fixing the expansion part and the matching part is provided inside the expansion part.
在一实施例中,所述介入部包括螺纹槽和用于连接所述配合件的插接槽,所述配合件可拆卸地套接于所述插接槽。In one embodiment, the intervening part includes a threaded groove and an insertion groove for connecting the fitting, and the fitting is detachably socketed in the insertion groove.
在一实施例中,所述介入部和所述配合件的接触面分别设有第一配合位和第二配合位,所述介入部和所述配合件通过所述第一配合位和所述第二配合位过盈配合。In one embodiment, the contact surfaces of the intervening part and the fitting part are respectively provided with a first fitting position and a second fitting part, and the intervening part and the fitting part pass through the first fitting part and the The second fit is an interference fit.
在一实施例中,还包括用于遮挡所述介入部的封闭膜,所述介入部形成于贯穿所述膨胀件的通道,所述封闭膜位于所述第二膨胀区远离所述第一膨胀区的一侧。In one embodiment, it further includes a closing film for covering the intervening part, the intervening part is formed in the channel passing through the expansion member, and the closing film is located in the second expansion area away from the first expansion side of the area.
在一实施例中,所述膨胀件还具有用于充盈所述膨胀件的充盈口,所述充盈口位于所述介入部远离所述第一膨胀区的一端。In an embodiment, the expansion member further has a filling opening for filling the expansion member, and the filling opening is located at an end of the intervening portion away from the first expansion area.
本发明提供的用于封堵左心耳的心脏治疗装置,通过在膨胀件的第一薄膜和第二薄膜之间装设支撑件,以提高心脏治疗装置的韧性,主要加强其与左心耳之间的贴壁性,提高封堵密闭效果,支撑件提高膨胀件在封堵位置的支撑力,降低膨胀件被心脏组织压迫变形的风险。膨胀件具有填堵在左心耳开口内的第一膨胀区和锚定在左心耳靠近左心房侧的开口处的第二膨胀区,设置在第二膨胀区的支撑件的弹性模量可以小于膨胀件的弹性模量,使得支撑件在第二膨胀区对应的位置起到主要支撑作用,能够提高支撑力,同时加强心脏治疗装置的密封效果。In the heart treatment device for blocking the left atrial appendage provided by the present invention, a support member is installed between the first film and the second film of the expansion member to improve the toughness of the heart treatment device, mainly to strengthen the space between it and the left atrial appendage. The wall-adherence improves the sealing effect of the occlusion, and the support member improves the support force of the expansion part at the occlusion position, reducing the risk of the expansion part being compressed and deformed by the heart tissue. The expansion member has a first expansion area filled in the opening of the left atrial appendage and a second expansion area anchored at the opening of the left atrial appendage near the left atrium side, and the elastic modulus of the supporting member arranged in the second expansion area can be smaller than the expansion area. The elastic modulus of the component makes the supporting component play a main supporting role at the position corresponding to the second expansion zone, which can increase the supporting force and enhance the sealing effect of the cardiac treatment device.
附图说明Description of drawings
为了更清楚地说明本发明实施例的技术方案,下面将对实施例中所需要使用的附图作简单地介绍,应当理解,以下附图仅示出了本发明的某些实施例,因此不应被看作是对范围的限定,对于本领域普通技术人员来讲,在不付出创造性劳动的前提下,还可以根据这些附图获得其他相关的附图。In order to illustrate the technical solutions of the embodiments of the present invention more clearly, the accompanying drawings used in the embodiments will be briefly introduced below. It should be understood that the following drawings only show some embodiments of the present invention, and thus It should be regarded as a limitation on the scope, and those skilled in the art can also obtain other related drawings based on these drawings without creative work.
图1为本发明第一实施例中心脏治疗装置的结构示意图。Fig. 1 is a schematic structural diagram of a heart treatment device in a first embodiment of the present invention.
图2为图1中支撑件与配合件的结构示意图。FIG. 2 is a structural schematic diagram of the supporting member and the matching member in FIG. 1 .
图3为图1中膨胀件与支撑件的结构示意图。Fig. 3 is a structural schematic diagram of the expansion member and the support member in Fig. 1 .
图4为图1中支撑件的正视示意图。FIG. 4 is a schematic front view of the support in FIG. 1 .
图5为图1中支撑件的侧视示意图。FIG. 5 is a schematic side view of the support in FIG. 1 .
图6为图1中第一支撑部的结构示意图。FIG. 6 is a schematic structural diagram of the first supporting part in FIG. 1 .
图7为图1中第二支撑部的结构示意图。Fig. 7 is a schematic structural diagram of the second supporting part in Fig. 1 .
图8为图1中配合件的结构示意图。FIG. 8 is a schematic structural diagram of the fitting in FIG. 1 .
图9为本发明的第二实施例中心脏治疗装置的结构示意图。Fig. 9 is a schematic structural diagram of a heart treatment device in a second embodiment of the present invention.
图10为图9中支撑件与配合件的结构示意图。FIG. 10 is a schematic structural view of the supporting member and the matching member in FIG. 9 .
具体实施方式Detailed ways
下面将结合附图,对本发明的特定实施例进行详细描述。显然,所描述的实施例仅仅是本发明的一部分实施例,而不是全部的实施例。基于本发明的描述,本领域普通技术人员在没有作出创造性劳动前提下所获得的所有其他实施例,都属于本发明保护的范围。Specific embodiments of the present invention will be described in detail below with reference to the accompanying drawings. Apparently, the described embodiments are only some of the embodiments of the present invention, not all of them. Based on the description of the present invention, all other embodiments obtained by persons of ordinary skill in the art without creative efforts fall within the protection scope of the present invention.
在本发明的描述中,除非另有明确的规定和限定,术语“设置”、“安装”、“连接”等应做广义理解,例如,可以是固定连接,也可以是可拆卸连接,或一体地连接;可以是机械连接,也可以是电连接;可以是直接相连,也可以通过中间媒介间接相连。对于本领域的普通技术人员而言,可以具体情况理解上述术语的具体含义。In the description of the present invention, unless otherwise specified and limited, the terms "installation", "installation", "connection" and so on should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integrated Ground connection; it can be mechanical connection or electrical connection; it can be direct connection or indirect connection through an intermediary. Those of ordinary skill in the art can understand the specific meanings of the above terms in specific situations.
术语“上”、“下”、“左”、“右”、“前”、“后”、“顶”、“底”、“内”、“外”等指示的方位或位置关系为基于附图所示的方位或位置关系,或者是该发明产品使用时惯常摆放的方位或位置关系,仅是为了便于描述和简化描述,而不是指示或暗示所指的装置或元件必须具有特定的方位、以特定的方位构造和操作,因此不能理解为对本发明的限制。The orientation or positional relationship indicated by the terms "upper", "lower", "left", "right", "front", "rear", "top", "bottom", "inner", "outer" etc. is based on the attached The orientation or positional relationship shown in the figure, or the conventional orientation or positional relationship of the invention product in use, is only for the convenience of description and simplification of the description, not to indicate or imply that the referred device or element must have a specific orientation , constructed and operated in a particular orientation and therefore should not be construed as limiting the invention.
术语“第一”、“第二”、“第三”等仅仅是为了区别属性类似的元件,而不是指示或暗示相对的重要性或者特定的顺序。The terms "first", "second", "third", etc. are only used to distinguish elements of similar nature, and do not indicate or imply relative importance or a specific order.
术语“包括”、“包含”或者其任何其他变体,意在涵盖非排他性的包含,除了包含所列的那些要素,而且还可包含没有明确列出的其他要素。The terms "comprising", "comprising", or any other variation thereof, are intended to cover a non-exclusive inclusion of elements other than those listed and also other elements not expressly listed.
第一实施例first embodiment
请参图1至图8,本发明的其中一个实施方式提供一种心脏治疗装置,用于封堵左心耳,包括膨胀件10以及与膨胀件10可拆卸地固定的配合件30,膨胀件10呈中空结构,膨胀件10包括相互叠设的第一薄膜和第二薄膜,第一薄膜和第二薄膜之间设有支撑件20,膨胀件10沿径向包括第一膨胀区11和第二膨胀区12,支撑件20至少设于第二膨胀区12,在本实施例中,支撑件20贯穿分布与第一膨胀区11和第二膨胀区12,膨胀件10通过配合件30将左心耳固定。Please refer to FIG. 1 to FIG. 8 , one embodiment of the present invention provides a cardiac treatment device for occluding the left atrial appendage, including an
具体地,膨胀件10可通过注射液体或气体,实现膨胀件10的膨胀,膨胀后的体积可以由外科医生根据患者的心房结构或形态选择,此处不做限制。第一膨胀区11对应的支撑件20和第二膨胀区12对应的支撑件20可以相互连接也可以不连接,第一膨胀区11将左心耳开口的组织撑起,第二膨胀区12锚定在左心房侧的左心耳开口处,第二膨胀区12的径向宽度比第一膨胀区11的径向宽度大,以阻止第一膨胀区11继续往左心耳方向滑入在左心耳开口内,将膨胀件10紧密贴壁封堵与左心耳开口内后,将配合件30与膨胀件10连接,配合件30远离膨胀件10的一端将左心耳收拢固定。Specifically, the
上述包括膨胀件10、支撑件20与配合件30的心脏治疗装置区别于现有技术主要具有如下有益效果:1.在第一膨胀区11内设置的支撑件20起到支撑膨胀件10的作用,使得膨胀件10在左心耳开口内的封堵效果更稳定,延长膨胀件10的使用寿命;2.第二膨胀区12主要用于防止血液从左心房流入左心耳开口,该处优选为支撑件20起主要支撑作用,能够提高心脏治疗装置的支撑力和封堵密闭性;3.左心耳通过配合件30与膨胀件10连接,实现心脏治疗装置和左心耳的固定,阻断左心房与左心耳之间的血液流通,并且提高心脏治疗装置的封堵稳定性。The above-mentioned cardiac treatment device including the
在本实施例中,第一薄膜和第二薄膜分别位于支撑件20的相对两侧,第一薄膜的熔点高于第二薄膜的熔点,支撑件20与第一薄膜连接。In this embodiment, the first film and the second film are respectively located on opposite sides of the
具体地,第一薄膜位于膨胀件10的相对内侧,则第二薄膜位于膨胀件10的相对外侧,支撑件20优选采用合金材质,合金具有质轻、无磁性、无毒性、抗腐蚀性、强度高、韧性好等优点,在外科治疗领域,人体植入物的用量也在逐渐增加,但是人体通常会排斥金属植入物,若血液直接流经金属支撑件20,有较大可能会由于受到异物阻碍而形成血栓,导致患者在植入术后需要长时间服用抗凝药物,本实施例中将支撑件20设于第一薄膜和第二薄膜之间并与第一薄膜连接,以隔绝金属异物与血液,避免了血栓的形成,支撑件20与膨胀件10的连接方式主要是将支撑件20粘接在加热后的第一薄膜上,第一薄膜和/或第二薄膜的制备材料可以为聚合物,例如:橡胶、聚酯材料等,由于第二薄膜与人体心脏组织直接接触,至少需要在第二薄膜的外表面涂布抗凝涂层。Specifically, the first film is located on the relative inner side of the
第一薄膜和第二薄膜的设置具有以下有益效果:1.第二薄膜的面积相对第一薄膜的面积较大,支撑件20粘接在第一薄膜上可以在完全贴附的情况下减小连接接触面积,简化制备工艺,同时也可以降低第二薄膜的材质、工艺等方面的要求;2.由于第二薄膜无需加热,第一薄膜的熔点优选为高于第二薄膜的熔点,能够扩大第二薄膜的选用范围;3.在第二薄膜的外表面涂布抗凝涂层旨在提高心脏治疗装置的抗凝效果。The arrangement of the first film and the second film has the following beneficial effects: 1. The area of the second film is larger than that of the first film, and the
在本实施例中,支撑件20包括设于第一膨胀区11的第一支撑部21和设于第二膨胀区12的第二支撑部22,支撑件20中第一支撑部21的弹性模量大于膨胀件10的弹性模量。In this embodiment, the
具体地,支撑件30中的第一支撑部21的弹性模量大于膨胀件10的弹性模量,第二支撑部22的弹性模量小于膨胀件10的弹性模量。1.实现心脏治疗装置在左心耳开口内的封堵区域为膨胀件10起到主要封堵支撑作用,第一支撑部21起到支撑膨胀件10,增加韧性;2.在左心房侧的左心耳开口处的锚定区域为第二支撑部22起到主要封堵支撑作用,增加心脏治疗装置的贴壁效果和密闭性。Specifically, the elastic modulus of the
在其他实施例中,支撑件20设于第二膨胀区12,支撑件20的弹性模量小于膨胀件10的弹性模量。In other embodiments, the supporting
在本实施例中,第一支撑部21的弹性模量大于第二支撑部22的弹性模量。In this embodiment, the elastic modulus of the first supporting
具体地,在心脏治疗装置介入左心耳开口内的过程中,需要先将第一支撑部21的体积缩小,其进入到封堵位置后恢复原有体积,以达到增加贴壁性的效果;且在左心房侧第二支撑部22其主要支撑作用,通过减小其弹性模量以增加支撑力。Specifically, when the heart treatment device is inserted into the opening of the left atrial appendage, the volume of the
在本实施例中,支撑件20形成于至少一层支撑网,第一支撑部21的网格密度大于或等于第二支撑部22的网格密度,和/或,第一支撑部21的支撑网的数量大于第二支撑部22的支撑网的数量,多层支撑网之间相互叠设。In this embodiment, the
具体地,支撑件20可以控制支撑网的数量或者控制支撑网的网格密度,以分别调整第一支撑部21和第二支撑部22的弹性模量。其中,支撑网的网格密度越大,支撑效果越好;支撑网的网格密度越小,支撑效果越差;或者,支撑网的层数越多,支撑效果越好;支撑网的层数越少,支撑效果越差。Specifically, the
根据以上所述的第一支撑部21的弹性模量大于第二支撑部22的弹性模量,支撑件20可以设置为第一支撑部21的支撑网的网格密度大于第二支撑部22的支撑网的网格密度;或者,第一支撑部21的支撑网的数量大于第二支撑部22的支撑网的数量。利用金属材料本身的结构调整弹性模量,能够利用金属材料的质轻、无磁性、无毒性、抗腐蚀性、强度高、韧性好等特性,降低支撑件20在制备材料上的选用难度。According to the above-mentioned elastic modulus of the
在本实施例中,配合件30具有互相垂直设置的插接部31和夹持部32,膨胀件10与配合件30通过插接部31连接,夹持部32位于第一膨胀区11远离第二膨胀区12的一侧。In this embodiment, the fitting 30 has an inserting
具体地,配合件30的形状可以为伞状或者树状,其中夹持部32相对具有较大的横向面积,夹持部32的形状类似于树枝,树枝状的夹持部32能够增加其与左心耳的连接稳定性,插接部31则具有较长的长度,插接部31的长度方向垂直于夹持部32的横向,使得插接部31伸入膨胀件10内后,夹持部32被限制在膨胀件10外,左心耳被夹持部32牵引而与固定于膨胀件10。Specifically, the shape of the fitting 30 can be umbrella-shaped or tree-shaped, wherein the clamping
在本实施例中,膨胀件10的内部设有用于将膨胀件10与配合件30相对固定的介入部P,介入部P也可以用于将膨胀件10介入人体。In this embodiment, the inside of the
在本实施例中,介入部P包括螺纹槽和用于连接配合件30的插接槽,配合件30可拆卸地套接于插接槽,螺纹槽与插接槽连通,在其他实施例中,螺纹槽与插接槽水密隔断。In this embodiment, the intervening part P includes a threaded groove and an insertion groove for connecting the fitting 30. The fitting 30 is detachably socketed in the insertion groove, and the thread groove communicates with the insertion groove. In other embodiments , The threaded groove and the socket groove are watertightly separated.
具体地,介入部P自第一膨胀区11向第二膨胀区12贯穿整个膨胀件10,螺纹槽位于介入部P靠近第二膨胀区12的一端,插接槽位于介入部P靠近第一膨胀区11的一端,心脏治疗装置的介入与配合件30的插接互不干涉。进一步地,插接部31与介入部P可拆卸地连接,能够实现在手术过程中匹配合适的膨胀件10或配合件30的尺寸,也可以适应性调整固定位置,提高治疗效果。Specifically, the intervening portion P runs through the
在本实施例中,介入部P和配合件30的接触面分别设有第一配合位和第二配合位,介入部P和配合件30通过第一配合位和第二配合位过盈配合。In this embodiment, the contact surfaces of the intervening part P and the
具体地,防止插接部31和介入部P插套安装后发生转动或移动,在插接部31和介入部P的接触面分别设置第一配合位和第二配合位,第一配合位和第二配合位之间可以是通过螺纹连接或是通过凹凸结合的限位方式连接。当第一配合位和第二配合位之间通过螺纹连接时,第一配合位由第一螺纹形成,则插接部31为螺纹杆,螺纹杆具有与第一螺纹过盈配合的第二螺纹,第二配合位由第二螺纹形成;当第一配合位和第二配合位之间可以是通过凹凸结合的限位方式连接时,第一配合位由限位凹槽形成,第二配合位由于限位凹槽过盈配合的限位凸起形成,本实施例中插接部31和介入部P的配合方式优选为通过限位凹槽和限位凸起形成过盈配合,减小连接处的摩擦力,提高使用寿命,也便于插接部31的拆卸。Specifically, to prevent the
在本实施例中,由于介入部P形成于贯穿膨胀件10的通道,介入部P的插接槽和螺纹槽之间为连通状态,较窄的空间内装设封闭膜具有较高的制备难度,并且不便于检查其封闭效果,本实施例设置用于遮挡介入部P的封闭膜,封闭膜位于第二膨胀区12远离第一膨胀区11的一侧。In this embodiment, since the intervening part P is formed in the passage through the
具体地,安装心脏治疗装置或充盈膨胀件10时需要打开介入部P的开口,在心脏治疗装置的植入手术完成后,介入部P靠近第二膨胀区12的一端的开口需要关闭或者隐藏,以隔绝介入部P与左心房的血液流通,在本实施例中优选采用可活动的封闭膜附在介入部P靠近第二膨胀区12的一端的开口处,在安装心脏治疗装置或充盈膨胀件10时将封闭膜掀开,完成心脏治疗装置的安装或充盈完成膨胀件10后,封闭膜自动将开口遮挡,避免插接部31和介入部P之间的连接缝隙对心脏治疗装置的封堵效果和密封性产生影响。封闭膜的连接方式可以是将封闭膜的一部分固定遮挡在开口处,留出一部分用于掀开或关闭,该留出的部分能够通入本领域技术人员常规选择的输送导管。Specifically, the opening of the intervention part P needs to be opened when installing the heart treatment device or the
在本实施例中,膨胀件10还具有用于充盈膨胀件10的充盈口,充盈口位于介入部P远离第一膨胀区11的一端。In this embodiment, the
具体地,第一鞘管通常从第二膨胀区12将心脏治疗装置介入人体,用于充盈膨胀件10的充盈口优选为位于介入部P靠近第二膨胀区12的一端,能够在安装心脏治疗装置的同时将膨胀件10充盈。充盈口位于螺纹槽远离第一膨胀区11的一端,避免膨胀件10的充盈影响第一鞘管的与心脏治疗装置的连接。Specifically, the first sheath usually introduces the cardiac treatment device into the human body from the
第二实施例second embodiment
请参图9和图10,本发明的另一个实施方式提供的一种用于封堵左心耳的心脏治疗装置,与第一实施例的不同在于,在本实施例中,第一膨胀区11具有连接部111和安装部112,连接部111和安装部112分别位于第一膨胀区11的两端,第二膨胀区12与连接部111连接。第一支撑部21仅位于第一膨胀区11的安装部112,第二支撑部22设于第二膨胀区12。Please refer to FIG. 9 and FIG. 10 , another embodiment of the present invention provides a cardiac treatment device for occluding the left atrial appendage. The difference from the first embodiment is that in this embodiment, the
具体地,左心耳开口内主要起支撑作用的部位位于膨胀件10远离第二膨胀区12的末端,即安装部112所在处,第一支撑部21仅设于安装部112能够减小心脏治疗装置的体积或重量,降低心房负担,并且保持膨胀件10末端的支撑力。Specifically, the part that mainly plays a supporting role in the left atrial appendage opening is located at the end of the
本发明提供的如第一实施例或第二实施例所述的心脏治疗装置可以但不限于通过以下步骤介入人体:The heart treatment device provided by the present invention as described in the first embodiment or the second embodiment can be inserted into the human body through the following steps, but not limited to:
S1:按照本领域的外科手术医生的常规操作,经股静脉将导管导丝送入右心房,穿刺房间隔后留置导丝于左心房内,将第一鞘管与膨胀件10通过介入部P的螺纹槽连接,将皮肤扩张管插入第一鞘管内,一起沿导丝送入左心房,退出皮肤扩张管,经第一鞘管送入猪尾导管,调整导管方向,将猪尾导管送入左心耳内,将第一鞘管沿猪尾导管送入左心耳内,通过第一鞘管的注水口向膨胀件10内充入液体,该液体为外科手术常规选择的液体,使膨胀件10完全封堵左心耳开口,支撑件20具有一定的支撑效果,提高稳定性,膨胀件10上与第一鞘管连接的充盈口设有单向阀门,鞘管内设有软管,该软管插入单向阀门内,实现向膨胀件10内注水及抽水,封堵严实后拔出该软管,膨胀件10上的单向阀门自动关闭,防止液体外漏;S1: According to the routine operation of surgeons in this field, the catheter guide wire is sent into the right atrium through the femoral vein, the atrial septum is punctured and the guide wire is placed in the left atrium, and the first sheath and the
S2:经猪尾导管抽吸左心耳内残余血液,撤出猪尾导管,沿第一鞘管插入第二鞘管,第一鞘管内装置有皮肤扩张管,沿第二鞘管插入穿刺导丝,以高频电能穿透左心耳进入心包腔,沿导丝推送第二鞘管通过左心耳进入心包腔,交换左房导丝进入心包腔后退出皮肤扩张管及导丝,留置第二鞘管于心包腔内;S2: Aspirate the residual blood in the left atrial appendage through the pigtail catheter, withdraw the pigtail catheter, insert the second sheath along the first sheath, and insert a puncture guide wire along the second sheath with a skin expansion tube in the first sheath. High-frequency electric energy penetrates the left atrial appendage and enters the pericardial cavity, pushes the second sheath along the guide wire through the left atrial appendage and enters the pericardial cavity, exchanges the left atrium guide wire and enters the pericardial cavity, exits the skin expansion tube and guide wire, and indwells the second sheath in the pericardium cavity;
S3:将配合件30与用于连接配合件30的钢缆连接后,沿第二鞘管推送心脏治疗装置,在心包腔内释放配合件30的夹持部32部分,后开始后撤第二鞘管,但未完全撤除第二鞘管,将左心耳体部挤压于配合件30与膨胀件10之间,固定推送杆及第一鞘管不动,继续后撤第二鞘管,于第一鞘管内部释放配合件30插接部31,与介入部P内壁配合连接,旋转钢缆即可释放配合件30,退出连接配合件30的钢缆及第二鞘管,断开第一鞘管与心脏治疗装置的连接,完全释放心脏治疗装置,撤出第一鞘管后,活动盖膜自然下落,以封闭介入部P的螺纹槽和介入部P。S3: After connecting the fitting 30 with the steel cable used to connect the fitting 30, push the cardiac treatment device along the second sheath, release the clamping
进一步地,在步骤三中,第一鞘管尾部的注水口内设有软管,软管头端插入单向阀门内,在膨胀件10与第一鞘管分离前通过软管向膨胀件10内注水或抽水,待封堵完成并检查效果良好后,撤出软管,将软管退入第一鞘管内,将第一鞘管与膨胀件10分离。Further, in step 3, a hose is provided in the water injection port at the tail of the first sheath, and the head end of the hose is inserted into the one-way valve, and the
此外,在钢缆释放配合件30前,通过推拉实验、超声检测、造影评估等方法检查心脏治疗装置是否能够成功封堵住左心耳开口,根据需要将心脏治疗装置重新收回,增加压力或更换不同型号的心脏治疗装置,可实现心脏治疗装置的重复收放,如果系统定位不满意,可以完全收回膨胀件10或配合件30并重新封堵,使用后可根据需要进行更换型号,提高了产品的利用率,封堵效果显著增强。In addition, before the steel cable releases the fitting 30, check whether the heart treatment device can successfully block the opening of the left atrial appendage through push-pull experiments, ultrasound detection, contrast evaluation, etc. The heart treatment device of the model can realize the repeated retraction of the heart treatment device. If the system positioning is not satisfactory, the
本发明提供的用于封堵左心耳的心脏治疗装置,通过在膨胀件10的第一薄膜和第二薄膜之间装设支撑件20,以提高心脏治疗装置的韧性,主要加强其与左心耳之间的贴壁性,提高封堵密闭效果,支撑件提高膨胀件10在封堵位置的支撑力,降低膨胀件10被心脏组织压迫变形的风险。膨胀件10具有填堵在左心耳开口内的第一膨胀区11和锚定在左心耳靠近左心房侧的开口处的第二膨胀区12,设置在第二膨胀区12的支撑件20的弹性模量可以小于膨胀件10的弹性模量,使得支撑件20在第二膨胀区12对应的位置起到主要支撑作用,能够提高支撑力,同时加强心脏治疗装置的密封效果。The heart treatment device for blocking the left atrial appendage provided by the present invention, by installing a
以上所述,仅为本发明的具体实施方式,但本发明的保护范围并不局限于此,任何熟悉本技术领域的技术人员在本发明揭露的技术范围内,可轻易想到的变化或替换,都应涵盖在本发明的保护范围之内。因此,本发明的保护范围应以所附的权利要求为准。The above is only a specific embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Anyone skilled in the art can easily think of changes or substitutions within the technical scope disclosed in the present invention. All should be covered within the protection scope of the present invention. Therefore, the protection scope of the present invention should be determined by the appended claims.
Claims (10)
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