HK1237286B - Container for a heart pump device and method for operating a heart pump device - Google Patents
Container for a heart pump device and method for operating a heart pump deviceInfo
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- HK1237286B HK1237286B HK17110993.7A HK17110993A HK1237286B HK 1237286 B HK1237286 B HK 1237286B HK 17110993 A HK17110993 A HK 17110993A HK 1237286 B HK1237286 B HK 1237286B
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Description
技术领域Technical Field
本发明属于机械和工程领域,亦即精密工程,可有益地应用于医学技术领域。本发明特别涉及用于心脏泵装置的有益包装。The invention belongs to the field of mechanics and engineering, namely precision engineering, and can be advantageously applied in the field of medical technology. In particular, the invention relates to an advantageous packaging for a heart pump device.
背景技术Background Art
近年来,机械心脏泵的应用越来越多,用于辅助或替换患者的心脏活动。基本上,这种泵是在病人体内或外部操作的。然而,在许多情况下,希望将这种泵植入病人体内。In recent years, the use of mechanical heart pumps has increased significantly to assist or replace a patient's heart activity. Typically, these pumps operate inside or outside the patient's body. However, in many cases, it is desirable to implant these pumps in the patient's body.
在这种情况下,泵可以在很大程度上压缩和扩张,使它们能够以小尺寸植入,再在病人的体内扩张,这些都是已经知的。这种泵的一种特殊类型中包括有沿轴向输送血液的可驱动的转子,其中带有泵壳体的转子可以优选地被送入心室或主动脉的区域并在其中操作。要将这样的泵输送到患者体内,可以例如通过血管到达心脏来实现。In this case, pumps that can be compressed and expanded to a large extent, allowing them to be implanted in a small size and then expanded in the patient's body, are already known. A special type of such pump includes a drivable rotor that transports blood axially, wherein the rotor with the pump housing can preferably be introduced into the region of the ventricles or the aorta and operated therein. Delivery of such a pump into the patient's body can be achieved, for example, through blood vessels to the heart.
当然,对于这种心脏泵系统的制造、运输和植入准备来说,可靠的无菌是必要的。如果心脏泵装置的某些部件没有专业和仔细地从无菌包装中取出,就会有危险。特别是,植入的部件必须防止与病人身体外的物体接触。例如,绒毛的污染也会严重损害这种泵的功能,并且在某些情况下,手的不正确接触可能造成严重损害。Naturally, reliable sterility is essential for the manufacture, transportation, and preparation for implantation of such heart pump systems. Certain components of the heart pump system can be dangerous if they are not expertly and carefully removed from their sterile packaging. In particular, implanted components must be protected from contact with objects outside the patient's body. For example, contamination of the villi can severely impair the function of such pumps, and in some cases, even improper hand contact can cause serious damage.
发明内容Summary of the Invention
在此背景下,本发明的目的是提供一种用于心脏泵装置的容器,该容器能够可靠地保护心脏泵装置的部件,使其保持无菌状态,并允许在移除中降低被污染的风险。Against this background, the object of the present invention is to provide a container for a heart pump device which reliably protects the components of the heart pump device, keeps them sterile, and allows a reduced risk of contamination during removal.
根据本发明,此目的是通过本发明的技术特征来实现的。在实施方案中规定了设计。According to the present invention, this object is achieved by the technical features of the present invention. The design is specified in the embodiment.
因此,本发明的各方面尤其涉及一种具有用于可压缩且可扩张的心脏泵的第一接纳空间的用于心脏泵装置的容器,其中所述第一接纳空间由一个或多个闭合元件在多个面上,特别是在所有面上,界定,并且对外隔绝,以免心脏泵被接触,其中所述闭合元件留下用于使导管从外部通入到所述第一接纳空间的开口,其中所述开口直径的尺寸使得心脏泵可以在与已扩张条件相比至少部分压缩的条件下完全通过所述装置。Therefore, aspects of the present invention relate in particular to a container for a heart pump device having a first receiving space for a compressible and expandable heart pump, wherein the first receiving space is delimited on multiple sides, in particular on all sides, by one or more closing elements and is isolated from the outside to prevent the heart pump from being accessed, wherein the closing elements leave an opening for allowing a catheter to pass from the outside into the first receiving space, wherein the diameter of the opening is sized such that the heart pump can pass completely through the device in a condition at least partially compressed compared to an expanded condition.
因此,心脏泵装置包括至少一个可压缩且可扩张的心脏泵,以及其他视情况而定的部件,例如导管和/或导管冲洗装置,以及在所述导管内运行的用于所述心脏泵的驱动轴,以及还有的其他视情况而定的部件。Thus, the heart pump device comprises at least one compressible and expandable heart pump, and other components as appropriate, such as a catheter and/or a catheter flushing device, and a drive shaft for the heart pump running within the catheter, and further components as appropriate.
应为这种心脏泵装置提供容器。该容器包括第一接纳空间,心脏泵可以容纳其中,使其受到保护,不被闭合元件接触,例如不被操作人员接触。通过这种方式,闭合元件可以以流体密封的方式将所述闭合空间封闭,唯留所述用于导管通过的开口。然而,还可以构思让所述闭合元件包括开口,并且所述闭合元件中的一个构造为例如网格状的形式。例如,通过此种方式,可以使得针对第一接纳空间中的心脏泵的光学控制成为可能。然而,至少部分闭合元件的至少一部分可以设计为透光的形式,以允许观察到所述第一接纳空间内部。A container should be provided for such a heart pump device. The container comprises a first receiving space in which the heart pump can be accommodated so that it is protected from contact by the closing element, for example from contact by an operator. In this way, the closing element can close the closed space in a fluid-tight manner, leaving only the opening for the passage of the catheter. However, it is also conceivable for the closing element to comprise openings and for one of the closing elements to be constructed, for example, in the form of a grid. For example, in this way, optical control of the heart pump in the first receiving space can be made possible. However, at least a portion of at least some of the closing elements can be designed to be light-transmissive in order to allow observation of the interior of the first receiving space.
导管通道的开口用于引导直接连接到心脏泵的导管通过,其中有益地,所述导管的全长在所述容器的第二接纳空间中的第一接纳空间之外还留有余地。最后,设置在导管上用于操控的手柄可以在容器的第三接纳空间中有余地,并且在那里可以例如所有面上都类似地被所述容器的壁围绕。The opening of the catheter channel is used to guide a catheter directly connected to the heart pump, wherein advantageously, the entire length of the catheter remains free in the second receiving space of the container beyond the first receiving space. Finally, a handle provided on the catheter for manipulation can remain free in the third receiving space of the container and can be similarly surrounded there by the container wall, for example, on all sides.
开口直径的尺寸应该使得泵不能在扩张的状态下通过开口移出(该开口可以先在封包时较大,之后才用盖体关闭)。例如,可以构思处于扩张状态的泵被安装在第一接纳空间中,以便能够在其中操作以进行测试。泵的转子可以在例如穿过导管的驱动轴的驱动下旋转,以便测试心脏泵是否工作就绪。开口的有限尺寸确保了在这种扩张状态下的心脏泵不能简单地从第一接纳空间移除,例如被导管拔出。在这里,决定性的是泵或泵头不能用手接触的事实。与心脏泵无意中接触的风险进一步降低。由于开口的尺寸,确保了将心脏泵从第一接纳空间中取出时应是至少部分压缩的,从而可以将心脏泵直接拖入到施加在第一接纳空间的开口区域之外的护套中,所述护套至少容纳部分压缩状态下的泵。可以构思开口的直径小于6mm,优选小于5mm,尤其是小于4mm。The diameter of the opening should be such that the pump cannot be removed through the opening in the expanded state (the opening can initially be larger when packaged and only then closed with the cover). For example, it is conceivable that the pump in the expanded state is installed in the first receiving space so that it can be operated therein for testing. The rotor of the pump can be rotated, for example, by a drive shaft passing through a catheter, in order to test whether the heart pump is operational. The limited size of the opening ensures that the heart pump in this expanded state cannot be simply removed from the first receiving space, for example by being pulled out by the catheter. The decisive factor here is the fact that the pump or the pump head cannot be touched by hand. The risk of inadvertent contact with the heart pump is further reduced. Due to the size of the opening, it is ensured that the heart pump should be at least partially compressed when it is removed from the first receiving space, so that the heart pump can be directly pulled into a sheath applied outside the opening area of the first receiving space, said sheath accommodating the pump in at least a partially compressed state. It is conceivable that the diameter of the opening is less than 6 mm, preferably less than 5 mm, and in particular less than 4 mm.
根据本发明容器的一个有益设计,至少构思了闭合元件,尤其是完整容器,其主要由塑料材料,尤其是塑料箔组成。容器可以例如制造成俗称的弯曲刚性塑料箔的泡罩(blister)。但是,可以提供更厚的塑料材料,或者容器的一部分可以由以注射成型方法制造的塑料元件组成。如果容器主要由泡罩组成,则可以由塑料箔用深冲压法或压制方法成形。According to one advantageous embodiment of the container according to the invention, at least the closing element, in particular the entire container, is conceived to consist primarily of a plastic material, in particular a plastic foil. The container can, for example, be manufactured as a so-called blister of a flexible, rigid plastic foil. However, thicker plastic materials can be provided, or a portion of the container can consist of a plastic element manufactured by injection molding. If the container consists primarily of a blister, it can be formed from the plastic foil by deep drawing or pressing.
本发明的进一步有益的设计构思是,第一接纳空间主要由接合在一起的两个半壳状闭合元件界定。例如,接纳空间可以包括用于容纳心脏泵的槽状第一半壳,所述槽部划分出所述第一接纳空间,以及至少一个半壳状闭合元件可以放置在第一半壳上,以便完全封闭第一接接纳空间。如此形成盖体的第二半壳可以通过压合、粘合、焊接或任何其他接合方法接合到第一半壳,并且有益地不能被拆开,除非被破坏。通过这种方式,可以确保心脏泵从在厂商处被设置在接纳空间中后,直到植入之前都仍在第一接纳空间中,在这两个时间点的中间也不能被移除。A further advantageous design concept of the present invention is that the first receiving space is mainly defined by two half-shell-shaped closing elements joined together. For example, the receiving space can include a groove-shaped first half-shell for accommodating the heart pump, the groove dividing the first receiving space, and at least one half-shell-shaped closing element can be placed on the first half-shell to completely close the first receiving space. The second half-shell forming the cover body in this way can be joined to the first half-shell by pressing, gluing, welding or any other joining method and can advantageously not be disassembled unless it is destroyed. In this way, it can be ensured that the heart pump remains in the first receiving space from the time it is set in the receiving space at the manufacturer until it is implanted and cannot be removed in between these two time points.
因此,本发明可以构思让各闭合元件以不可释放或以难以释放的方式相互接合。The invention thus envisages that the closure elements engage with one another in a non-releasable or difficult to releasable manner.
两个半壳可以彼此相对放置,开口彼此相对或开口有相应的对齐。The two half-shells can be placed opposite each other with the openings facing each other or with the openings aligned accordingly.
此外,可以有益地构思将所述开口形成为让导管在两个闭合元件之间穿过,或开口朝向两个闭合元件之间的接合部位。这样,可以用一种相当简便的方式,将心脏泵和其上连接的导管在将多个闭合元件接合在一起划分出第一接纳空间之前插入到开口中。Furthermore, it is advantageously conceivable that the opening is formed so as to allow the catheter to pass between the two closure elements, or the opening is directed toward the joint between the two closure elements. In this way, the heart pump and the catheter connected thereto can be inserted into the opening in a relatively simple manner before the plurality of closure elements are joined together to define the first receiving space.
如上所述,一种有益地构思可以是所述闭合元件中的第一个被设计成接纳至少一个导管的泡罩的一部分,尤其是附加地,所述心脏泵装置的更多部分。As already mentioned above, an advantageous concept could be that a first one of the closure elements is designed as a part of a blister to receive at least one catheter and, in particular, additionally, further parts of the heart pump device.
此外还可以构思所述第一闭合元件在第一接纳空间的区域中形成用于流体的盛接壳。由此,用液体在第一接纳空间中润湿心脏泵以进行测试的操作得到了简化。此外,所述润湿对于泵的无损压缩是有益的。例如,可以通过导管将流体提供给心脏泵。盛接壳一方面确保流体聚集在泵周围来确保心脏泵的润湿,另一方面,确保流体不会以不受控制的方式逸出第一接纳空间。It is also conceivable that the first closing element forms a receiving shell for the fluid in the region of the first receiving space. This simplifies the wetting of the heart pump with liquid in the first receiving space for testing. Furthermore, such wetting is beneficial for lossless compression of the pump. For example, the fluid can be supplied to the heart pump via a catheter. The receiving shell ensures that the fluid accumulates around the pump to ensure wetting of the heart pump, and, on the other hand, prevents the fluid from escaping the first receiving space in an uncontrolled manner.
本发明还可以设计有通过至少部分由圆柱体对称通道组成的开口。这种优选具有光滑壁的圆柱体对称通道允许心脏泵在通过的同时压缩而不损伤心脏泵的外壳。由此,一种优选的构思可以是让圆柱形对称通道从所述第一接纳空间的内部向外变窄,且在泵通过的区域内没有锐边。The present invention can also be provided with an opening formed at least partially by a cylindrically symmetrical channel. This cylindrically symmetrical channel, which preferably has smooth walls, allows the heart pump to be compressed while passing through it without damaging the heart pump housing. Thus, a preferred concept can be that the cylindrically symmetrical channel narrows from the interior of the first receiving space outwards and has no sharp edges in the area where the pump passes.
用于此目的的圆柱体对称通道可以被设计为例如锥形或分段锥形(sectionwiseconical)的形式。例如通向第一接纳空间内部的伸出部(run-out)可包括引入漏斗,心脏泵可被拖入所述引入漏斗,并在其中至少部分压缩。The cylindrical symmetrical channel for this purpose can be designed, for example, in the form of a cone or a sectionwise cone. For example, the run-out to the interior of the first receiving space can include an introduction funnel, into which the heart pump can be drawn and at least partially compressed.
此外,还可以有益的是到所述闭合元件外侧和第一接纳空间的伸出部包括边缘,所述边缘上设有中空圆柱形护套元件,该空圆柱形护套元件可沿所述导管移动,并且可沿所述通道的轴向方向被支撑。Furthermore, it can also be advantageous if the projection to the outside of the closure element and to the first receiving space comprises an edge on which a hollow cylindrical sheath element is provided which is movable along the conduit and can be supported in the axial direction of the channel.
中空圆柱形部件形式的护套,尤其是例如可通过撕断开口而破坏性径向移除的剥离式护套,可以套在导管上,即可将导管拖入护套中,并且通常已经是位于容器中的心脏泵装置的构成部分。这样的护套元件可以从第一接纳空间的外侧压靠在闭合元件上开口的边缘上,从而可以利用穿过所述护套元件的导管,将所述心脏泵通过所述开口,从所述第一接纳空间中拖到所述护套元件中。因此,心脏泵至少部分地被径向压缩在接纳空间的开口内,并且特别是在进入护套元件时被进一步径向压缩。然而,还可以构思护套元件的内径对应于心脏泵已经在接纳空间的开口中被压缩的直径,从而可以减少拖入护套中时进一步的压缩。开口的边缘可以有益地沿着与开口的纵向轴线垂直的方向延伸的环形表面。A sheath in the form of a hollow cylindrical component, in particular a peel-off sheath that can be destructively removed radially, for example by tearing off the opening, can be slipped over a catheter, i.e., the catheter can be pulled into the sheath, and is typically already part of a heart pump device located in a container. Such a sheath element can be pressed against the edge of an opening in a closure element from the outside of a first receiving space, so that the heart pump can be pulled from the first receiving space into the sheath element through the opening using a catheter passing through the sheath element. The heart pump is thus at least partially radially compressed within the opening of the receiving space and, in particular, further radially compressed upon entering the sheath element. However, it is also conceivable that the inner diameter of the sheath element corresponds to the diameter of the heart pump already compressed within the opening of the receiving space, thereby reducing further compression upon pulling into the sheath. The edge of the opening can advantageously be an annular surface extending perpendicularly to the longitudinal axis of the opening.
当心脏泵被拉到护套元件中时,就可以将心脏泵装置从容器中取出,再通过引入护套引入患者体内。为此,护套元件套接到引入护套上,所述心脏泵从所述护套元件中被移出,进入所述引入护套。如果将护套元件设计为剥离式护套,则将心脏泵引入到引入护套中之后就可以将护套元件移除,不会有任何问题。但是,护套元件本身就可以作为引入护套,方法就是将泵压缩置于护套元件中,然后引入患者体内,例如通过牵引线引入。为此,要为牵引线提供一个单独的管腔。When the heart pump has been pulled into the sheath element, the heart pump device can be removed from the container and introduced into the patient via the introduction sheath. To this end, the sheath element is sleeved onto the introduction sheath and the heart pump is removed from the sheath element into the introduction sheath. If the sheath element is designed as a peel-off sheath, the sheath element can be removed without any problems after the heart pump has been introduced into the introduction sheath. However, the sheath element itself can serve as an introduction sheath in that the pump is compressed and placed in the sheath element and then introduced into the patient, for example via a traction wire. For this purpose, a separate lumen is provided for the traction wire.
本发明除了上述类型的容器之外,还在相应实施例中涉及具有心脏泵装置的容器,其中可压缩可扩张的心脏泵位于第一接纳空间中,并且其中连接到该心脏泵的导管通过开口从所述第一接纳空间向外伸出,其中尤其是导管所通过的护套元件以可自由移动的方式设置在导管之上。In addition to the container of the above-mentioned type, the present invention also relates to a container with a heart pump device in a corresponding embodiment, wherein a compressible and expandable heart pump is located in a first receiving space, and wherein a catheter connected to the heart pump protrudes outward from the first receiving space through an opening, wherein in particular a sheath element through which the catheter passes is arranged on the catheter in a freely movably manner.
本发明还涉及一种用于操作心脏泵装置的方法,运用该方法,将心脏泵布置在根据本发明所述的容器的第一接纳空间中,并且例如由外部的轴穿过导管到达心脏泵而驱动旋转(不过,在泵头上集成电动机的泵也是可以的)。该方法允许在容器中预先测试带转子的心脏泵的功能能力,不会发生直接接触和消毒后二次污染(de-sterilization)的危险。测试操作的速度通常低于病人身内的运行速度,例如在50%,尤其是只有30%,甚或最低的10%。The present invention also relates to a method for operating a heart pump device, wherein the heart pump is arranged in a first receiving space of a container according to the present invention and is driven in rotation, for example, by an external shaft passing through a catheter to the heart pump (although pumps with an electric motor integrated in the pump head are also possible). This method allows the functional capacity of the heart pump with the rotor to be pre-tested in the container without direct contact and the risk of post-sterilization contamination. The speed of the test operation is typically lower than the operating speed in the patient, for example at 50%, in particular only 30%, or even at least 10%.
为此,还可以有益地构思为让流体通过设置在导管上的开口,沿着导管输送到心脏泵。这样,就可以确保心脏泵在真实情况下与流体接触来接受测试。心脏泵装置可同时尽可能充满液体,从而大大避免了在植入时带入空气。任何生物相容性的冲洗液,例如盐溶液、葡萄糖溶液或类似物,都可考虑用作输送到心脏泵的液体。To this end, it is also advantageous to allow the fluid to be delivered to the heart pump along the catheter through an opening provided in the catheter. This ensures that the heart pump is tested in real-world contact with the fluid. The heart pump device can also be filled with fluid as much as possible, thereby significantly reducing the introduction of air during implantation. Any biocompatible flushing fluid, such as saline solution, glucose solution, or the like, can be used as the fluid delivered to the heart pump.
本发明还涉及一种用于操作心脏泵装置的方法,运用该方法,将心脏泵布置在根据本发明所述的容器的第一接纳空间中。其中心脏泵连接到导管,导管通过开口从第一接纳空间向外伸出,其特征在于心脏泵,通过导管,在径向压缩的状态下从第一接纳空间中穿过开口拔出,并拖入到护套元件中,该护套元件可在导管上沿轴向方向(即导管的纵向方向)自由移动。The present invention also relates to a method for operating a heart pump device, wherein the heart pump is arranged in a first receiving space of a container according to the present invention. The heart pump is connected to a catheter, which extends out of the first receiving space through an opening. The method is characterized in that the heart pump is pulled out of the first receiving space through the opening by the catheter in a radially compressed state and drawn into a sheath element that is freely movable on the catheter in the axial direction (i.e., in the longitudinal direction of the catheter).
在本发明中指定的对象尤其包括划分出可压缩和可扩张的心脏泵的接纳空间的一个或多个闭合元件。“接纳空间”最好理解为完全包围心脏泵泵头的最小完整空间(例如连接到移除开口7(参见例如图1到3)的进一步的部分则不属于此)。这是为了防止接触到心脏泵,即让心脏泵在接纳空间中被保护而不被接触。闭合元件留出至少一个让导管通过的自由开口,其中开口直径的尺寸使得心脏泵只能在与已扩张状态相比至少部分压缩的状态下通过。因此,“让导管通过”应理解为让相应的导管通过该开口,最好不要理解为有一定的通过方向。在本发明中提到了“一个或多个闭合元件”。尤其是在“多个闭合元件”的情况下,这些闭合元件可具有不同的设计。这意味着,形成接纳空间的闭合元件可以以不同的方式彼此连接。因此,该连接可以是例如通过螺纹连接等来实现。这种连接优选地使得其不能不经破坏就松开,不过也可以另选地以免破坏的方式制造。由此,扩张的泵可以容纳在接纳空间中,方式即为这些闭合元件“包围泵”连接在一起,此后不再能够以免破坏的方式彼此分离。在这种情况下,将不同的闭合元件彼此连接的接合线可以是沿着导管的纵向方向布置在接纳空间的开口外,也可以是与该方向垂直。这一点的有关具体细节在下文中具体说明。The subject matter of the present invention particularly includes one or more closure elements that delimit a receiving space for a compressible and expandable heart pump. A "receiving space" is preferably understood to mean the smallest complete space that completely surrounds the heart pump head (e.g., the further portion connected to the removal opening 7 (see, e.g., Figures 1 to 3 ) is not included in this context). This is to prevent access to the heart pump, i.e., to protect the heart pump from being touched in the receiving space. The closure element leaves at least one free opening for the passage of a catheter, wherein the diameter of the opening is dimensioned such that the heart pump can only be passed through in a state that is at least partially compressed compared to its expanded state. Therefore, "passing through a catheter" should be understood as allowing the corresponding catheter to pass through the opening, and preferably not in terms of a specific passage direction. Reference is made to "one or more closure elements" in the present invention. In particular, in the case of "a plurality of closure elements," these closure elements can have different designs. This means that the closure elements forming the receiving space can be connected to each other in different ways. Thus, the connection can be achieved, for example, by a screw connection. This connection is preferably such that it cannot be released without destruction, but can alternatively be manufactured in a destruction-proof manner. Thus, the expanded pump can be accommodated in the receiving space by having the closure elements connected together "around the pump" and subsequently unable to be separated from each other in a damage-proof manner. In this case, the joining lines connecting the various closure elements can be arranged outside the opening of the receiving space along the longitudinal direction of the catheter or perpendicular to this direction. The details of this aspect are described in detail below.
在一个实施例中,第一接纳空间由沿接合线连接的至少两个闭合元件界定,其中所述接合线在所述接纳空间中延伸处的横截面大于让导管通过的开口的横截面。以这种方式,闭合元件可以“包围泵头”而接合,而之后要抽出心脏泵(泵头)则只有在压缩状态下才有可能。In one embodiment, the first receiving space is delimited by at least two closure elements connected along a joint line, wherein the cross-section of the joint line extending in the receiving space is larger than the cross-section of the opening for the passage of the catheter. In this way, the closure elements can be joined "around the pump head", while subsequent extraction of the heart pump (pump head) is only possible in the compressed state.
进一步的实施例构思了包括多于一个开口的接纳空间。为此,例如可以基本不经压缩就将可压缩和可扩张的心脏泵拖入接纳空间。不过,之后要取出泵头(优选地设在接纳空间的相对端)就只可能是在压缩状态下(参见例如图11a)。A further embodiment envisages a receiving space comprising more than one opening. For this purpose, for example, a compressible and expandable heart pump can be drawn into the receiving space substantially without being compressed. However, subsequent removal of the pump head (preferably arranged at the opposite end of the receiving space) is only possible in the compressed state (see, for example, FIG. 11 a ).
进一步的发展构思让该接纳空间的至少一个开口由盖体封闭,该盖体接合到接纳空间的开口上,接合方式是无需破坏即可移除,也可以是破坏后移除。因此,例如可以如上所述,让泵首先通过较大的开口(不必迫使心脏泵压缩)进入接纳空间。然后,可以用盖体封闭,使得盖体不能以免破坏的方式被释放。以这种方式,确保心脏泵不能不经压缩就被使用者从接纳空间中移除。A further development envisages that at least one opening of the receiving space is closed by a cover that engages the opening of the receiving space in a manner that allows for removal without destruction or after destruction. Thus, for example, as described above, the pump can first be introduced into the receiving space through a larger opening (without forcing the heart pump to compress). It can then be closed with the cover in such a way that it cannot be released in a destructive manner. In this way, it is ensured that the heart pump cannot be removed from the receiving space by the user without being compressed.
还可以提供具有开口的接纳空间,使得心脏泵装置/心脏泵/泵头可以不经压缩就被引入到接纳空间中,但是只能在相比扩张状态至少部分压缩的状态下才能取出。It is also possible to provide a receiving space with an opening so that the heart pump device/heart pump/pump head can be introduced into the receiving space without being compressed, but can only be removed in a state that is at least partially compressed compared to the expanded state.
附图说明BRIEF DESCRIPTION OF THE DRAWINGS
以下通过附图中的实施例来表示本发明,并在后文中描述。由此示出:The present invention is illustrated below by way of example in the accompanying drawings and described below.
图1是根据本发明的容器的截面示意图,FIG1 is a schematic cross-sectional view of a container according to the present invention,
图2是根据本发明的带有心脏泵容器的截面图,FIG2 is a cross-sectional view of a container with a heart pump according to the present invention,
图3是容器的另一个截面图,FIG3 is another cross-sectional view of the container,
图4是带有导管的心脏泵,Figure 4 shows a heart pump with a catheter.
图5是带心脏泵容器的主视图,FIG5 is a front view of a container with a heart pump,
图6是具有心脏泵和具有护套元件的容器的截面图,FIG6 is a cross-sectional view of a container with a heart pump and with a sheath element,
图7是通过容器和护套元件的另一截面图,FIG7 is another cross-sectional view through the container and the sheath element,
图8是作为泡罩的实施例中的容器的三维视图,FIG8 is a three-dimensional view of the container in an embodiment as a blister,
图9是穿过被设计为泡罩的容器的截面图,FIG9 is a cross-sectional view through a container designed as a blister,
图10是被设计为泡罩的容器细节的三维视图,并且FIG10 is a three-dimensional view of a detail of a container designed as a blister, and
图11a和11b是根据本发明另一个实施例容器的截面图或部分截面图。11a and 11b are cross-sectional views or partial cross-sectional views of a container according to another embodiment of the present invention.
具体实施方式DETAILED DESCRIPTION
图1的截面图示出具有两个闭合元件5、6的容器1,其中第一闭合件5为实心体,第二闭合元件6为薄壁半壳,形如盖体,盖住第一接纳空间3。开口7设置在闭合元件5、6的区域中,并且尤其是在第一闭合元件5中作为凹部,通过该凹部,导管可以从第一接纳空间3伸出到外部空间中。可设置绕容器1一端延伸的沟道13,该沟道13可用于接纳导管,以允许安设一个或多个导管圈。第一闭合元件5的这种实心表示仅作为示例给出,以解释其基本功能。The cross-sectional view of FIG1 shows a container 1 having two closure elements 5 and 6, wherein the first closure element 5 is a solid body, and the second closure element 6 is a thin-walled half-shell, shaped like a lid, covering the first receiving space 3. An opening 7 is provided in the region of the closure elements 5 and 6, and in particular in the first closure element 5 as a recess through which a conduit can protrude from the first receiving space 3 into the exterior. A channel 13 extending around one end of the container 1 can be provided, which can be used to receive a conduit, thereby allowing one or more conduit loops to be installed. This solid representation of the first closure element 5 is provided merely as an example to explain its basic function.
第一闭合元件5应当形成流体密封的盛接盆14,心脏泵可被插入到其中,并且可以盛接流体,用于测试操作。The first closing element 5 should form a fluid-tight receptacle 14 into which the heart pump can be inserted and which can receive fluid for testing operations.
第二闭合元件6优选地在接合部位9的区域中不可释放地连接并密封地连接到第一闭合元件5,其中除了开口7之外,连接可以有益地被设计成流体密封的方式,但不是气密的方式(因为这里的空气应该从导管逸出)。在这个例子中,接合部位9形成一个接合线,或者说整体共面的环形接合面。The second closure element 6 is preferably non-releasably and sealingly connected to the first closure element 5 in the region of a joint 9, wherein, with the exception of the opening 7, the connection can advantageously be designed in a fluid-tight manner, but not in an airtight manner (since air should escape from the conduit here). In this example, the joint 9 forms a joint line or an overall coplanar annular joint surface.
第二闭合元件6可以设计为流体密封的弯曲的扁平塑料部件,优选地为刚性箔片,但是也可以包括开口和/或一个或多个光学窗口,以便允许观察第一接纳空间3。第二闭合元件6的决定性因素在于能够保护要保持在第一接纳空间3中的心脏泵,使之免于被接触。The second closing element 6 can be designed as a fluid-tight, curved, flat plastic part, preferably a rigid foil, but can also comprise openings and/or one or more optical windows in order to allow viewing into the first receiving space 3. A decisive factor for the second closing element 6 is its ability to protect the heart pump to be held in the first receiving space 3 from being touched.
如图2所示,容器1'中的第一闭合元件5'与与第二闭合元件6'一样,被设计为泡罩形硬箔。第一接纳空间3形如图1中的实施例,并且布置在第一接纳空间3中的心脏泵4在图2中示意性地示出。心脏泵4包括具有螺旋形输送元件4b和转毂4c的转子4a,其中转毂4c连接到可驱动的柔性驱动轴12。驱动轴12通过穿过开口7的导管8,从心脏泵4伸出。As shown in FIG2 , the first closure element 5′ in the container 1′ is designed as a blister-shaped rigid foil, just like the second closure element 6′. The first receiving space 3 is shaped like the embodiment in FIG1 , and the heart pump 4 arranged in the first receiving space 3 is schematically shown in FIG2 . The heart pump 4 includes a rotor 4a having a spiral conveying element 4b and a hub 4c, wherein the hub 4c is connected to a drivable, flexible drive shaft 12. The drive shaft 12 extends from the heart pump 4 via a catheter 8 that passes through an opening 7.
所示心脏泵4处于非压缩状态,在该状态下,其径向延伸垂直于由转毂4c指示的轴向,并且该径向延伸大于开口7的延伸。The heart pump 4 is shown in a non-compressed state in which its radial extension is perpendicular to the axial direction indicated by the hub 4 c and is greater than the extension of the opening 7 .
已经在图2中的III处示出和表示的部分同时也在图3中示出,视图中有第一闭合元件5'和第二闭合元件6'以及开口7,其中带驱动轴12的导管8被拖入,并且其中心脏泵4的轮廓以虚线绘制。从图3可以看出,心脏泵4的直径大于开口7的净宽,使得导管8上的心脏泵4只能在径向压缩的同时才能从第一接纳空间3的开口7中拔出。The part already shown and indicated at III in FIG2 is also shown in FIG3 , showing the first closure element 5 ′ and the second closure element 6 ′ and the opening 7 , into which the catheter 8 with the drive shaft 12 is drawn, and wherein the outline of the heart pump 4 is drawn in dashed lines. As can be seen in FIG3 , the diameter of the heart pump 4 is greater than the clear width of the opening 7 , so that the heart pump 4 on the catheter 8 can only be pulled out of the opening 7 of the first receiving space 3 while being radially compressed.
图4示出了具有已经在图2中描述的心脏泵4的心脏泵装置,以及带有传动轴12的导管8,其中还示出了具有磁耦合器15的驱动轴12的驱动侧端,所述耦合器允许将驱动运动从电动机16传递到容器17内,其中驱动轴12联接到磁耦合器。FIG4 shows a heart pump device having the heart pump 4 already described in FIG2 , and a catheter 8 with a drive shaft 12 , wherein the drive side end of the drive shaft 12 is also shown having a magnetic coupling 15 , which allows the drive movement to be transmitted from the electric motor 16 into the container 17 , wherein the drive shaft 12 is coupled to the magnetic coupling.
容器17还具有多个冲洗开口18、19,可起到冲洗装置的作用,其中冲洗流体例如盐水溶液通过开口18引入容器17中,并且通过第二冲洗开口19去除多余的冲洗流体。冲洗流体还沿导管8向着泵4的方向运动,尤其是随着转子的操作而移动,即随着驱动轴12的转动,通过驱动轴12的螺旋状外轮廓,向着泵4的方向输送。因此,为了进行试操作,可以将冲洗液送入第一冲洗口18,令其通过导管8,向着位于第一接纳空间3中的泵4运动,然后就可对泵进行试操作,至少是在被冲洗液体润湿的同时以降低的速度进行测试。The container 17 also has a plurality of flushing openings 18 and 19, which function as a flushing device, wherein a flushing fluid, such as a saline solution, is introduced into the container 17 through the opening 18, and excess flushing fluid is removed through the second flushing opening 19. The flushing fluid also moves along the conduit 8 toward the pump 4, and in particular moves with the operation of the rotor, i.e., with the rotation of the drive shaft 12, and is conveyed toward the pump 4 by the helical outer profile of the drive shaft 12. Thus, for a test operation, the flushing fluid can be introduced into the first flushing opening 18, allowed to move through the conduit 8 toward the pump 4 located in the first receiving space 3, and then the pump can be tested, at least at a reduced speed while being wetted with the flushing fluid.
图5以主视图示出了第一闭合元件5'以及第一接纳空间3的内部,其中设置有心脏泵4。连接在心脏泵4上的导管8通过开口7从第一接纳空间向外伸出,并且在接纳空间3外侧开口7的正面被护套元件11包围。护套元件11被设计为软管段形式的柔性塑料隆凸,该软管段可以具有预定的破开位置,这样作为剥离式护套的话,就可以在将泵4放入患者体上的引入护套后,在后期阶段径向拔出。FIG5 shows a front view of the first closure element 5 ′ and the interior of the first receiving space 3 in which the heart pump 4 is arranged. The catheter 8 connected to the heart pump 4 protrudes from the first receiving space through the opening 7 and is surrounded by a sheath element 11 on the front side of the opening 7 outside the receiving space 3. The sheath element 11 is designed as a flexible plastic protrusion in the form of a hose section, which can have a predetermined breaking point so that, in the case of a peel-off sheath, it can be radially removed at a later stage after the pump 4 has been placed in the introduction sheath on the patient.
护套元件11可以从外侧套到第一接纳空间3的闭合元件5'、6'上的开口7的边缘上,并且在此,泵4可以通过导管从箭头20的方向从接纳空间3中拔出。由于开口7的给定直径小于扩张状态下的泵直径,故而泵4是在压缩或至少部分压缩的状态下沿着箭头21、22的方向拖入开口7中,并在径向压缩的状态下被拖入护套元件11。在那里,泵同样被保护免受接触和污染,并且可以从容器1'中移除,再被移动到患者身体上的导入护套中。The sheath element 11 can be pulled from the outside onto the edge of the opening 7 in the closure elements 5 ', 6 ' of the first receiving space 3, and the pump 4 can be pulled out of the receiving space 3 via the catheter in the direction of the arrow 20. Since the given diameter of the opening 7 is smaller than the pump diameter in the expanded state, the pump 4 is drawn into the opening 7 in the direction of the arrows 21, 22 in a compressed or at least partially compressed state and drawn into the sheath element 11 in a radially compressed state. There, the pump is also protected from contact and contamination and can be removed from the container 1 ' and moved to an introduction sheath on the patient's body.
图6以侧视图再次示意性地示出了具有第一接纳空间3的容器1',其中设置有泵4和护套元件11,该护套元件11设置在容器1'的沟道13中并包围导管8。FIG. 6 again schematically shows a side view of the container 1 ′ with the first receiving space 3 , in which the pump 4 and the jacket element 11 are arranged, which is arranged in the channel 13 of the container 1 ′ and surrounds the line 8 .
图7根据图6中箭头23的方向上看到的又一视角,示出了具有开口7的闭合元件5'、6'的外部视图,以及沿轴向方向上的护套元件11的主视图,并且虚线表示位于第一接纳空间3中的心脏泵4。Figure 7 shows an external view of the closing elements 5', 6' with the opening 7 and a main view of the sheath element 11 in the axial direction according to another perspective seen in the direction of the arrow 23 in Figure 6, and the dotted line represents the heart pump 4 located in the first receiving space 3.
图8以透视图示出了被设计为泡罩的一部分的第一闭合元件5',其具有两个凹槽,第一凹槽24由第一闭合元件5'界定,并形成用于心脏泵的第一接纳空间的下部,而第二凹槽25划分了用于导管8上的手柄的第三接纳空间。此外,还可以辨认出沟道13,其从第一凹槽24引到第二凹槽25,形成第二接纳空间并允许设置导管,其中还形成了拱形的附加沟道13a,这允许放置导管圈。此外,在沟道13的区域中设置有手柄凹槽27、28,它们一方面用于泡罩的稳定,另一方面可在将位于沟道13内的导管取出时用于改进其手柄的操控,同时还用于形成泡罩的突起,从而在放置在靠近凹槽24、25的水平表面上时,可用作支撑元件。FIG8 shows a perspective view of a first closure element 5', designed as part of a blister, having two recesses. A first recess 24, delimited by the first closure element 5', forms the lower portion of a first receiving space for a heart pump, while a second recess 25 delimits a third receiving space for a handle on the catheter 8. Furthermore, a channel 13 can be seen, which leads from the first recess 24 to the second recess 25, forming a second receiving space and allowing for the placement of the catheter. An additional arched channel 13a is also formed, which allows for the placement of a catheter loop. Furthermore, handle recesses 27 and 28 are provided in the region of channel 13. These serve, on the one hand, to stabilize the blister and, on the other hand, to improve the handling of the handle when removing the catheter located within channel 13. They also form a protrusion on the blister, thus serving as a support element when placed on a horizontal surface adjacent to recesses 24 and 25.
心脏泵4以及手柄部26表示在容器1'或闭合元件5'内。然而通常,闭合元件设置在第一凹槽24以及第二凹槽25上,以便覆盖相应的凹槽和位于其中的部件,保护它们免受接触,并用做固定部件,保持振动中的固定,并且完成容器1”。因此,导管的无创尖端(俗称猪尾尖端(pigtail tip))也是固定的,使得其不允许泵头有过度活动,但另一方面,在护套元件11的方向上拔出又是不受限制的。The heart pump 4 and the handle portion 26 are shown inside the container 1' or the closure element 5'. However, usually, the closure element is arranged on the first groove 24 and the second groove 25 to cover the corresponding grooves and the components located therein, protecting them from contact, and serving as a fixing element to maintain the fixation during vibration and complete the container 1". Therefore, the atraumatic tip of the catheter (commonly known as the pigtail tip) is also fixed, so that it does not allow excessive movement of the pump head, but on the other hand, withdrawal in the direction of the sheath element 11 is not restricted.
在图9中,例示了穿过凹槽24的横截面,并且该横截面在形成为泡罩的一部分的第一闭合件5'中形成。突起29由闭合元件5'的适当突出拱顶形成,位于凹槽内,且在第一接纳空间内,其中突起29包括在第一接纳空间3内容纳心脏泵4的凹部30。这样可让心脏泵4在第一接纳空间3中准确、紧密和受力地放置。此外,第一接纳空间3完全由硬塑料箔形式的第二闭合元件6”覆盖,其中第二闭合元件6”与第一闭合元件5'的接触面区域可以是粘接、焊接或压接(例如也可通过类似于键的连接),使得要不破坏容器1”就分离第二闭合元件6”是不可能的或者仅是非常难以实现的。在这个例子中,第一和第二闭合元件5'、6”的开放侧朝着相同的方向而不是相对方向,但其实相对方向也是可以的。FIG9 illustrates a cross-section through the recess 24 formed in the first closure element 5', which is formed as part of the blister. A protrusion 29, formed by a suitable protruding dome of the closure element 5', is located within the recess and within the first receiving space 3. The protrusion 29 includes a recess 30 for accommodating the heart pump 4 within the first receiving space 3. This ensures that the heart pump 4 is positioned accurately, securely, and securely within the first receiving space 3. Furthermore, the first receiving space 3 is completely covered by a second closure element 6" in the form of a hard plastic foil. The contact surface area of the second closure element 6" with the first closure element 5' can be glued, welded, or crimped (e.g., also by a key-like connection), making it impossible or only very difficult to separate the second closure element 6" without destroying the container 1". In this example, the open sides of the first and second closure elements 5', 6" face the same direction, rather than opposite directions, although opposite directions are also possible.
第二凹槽25的闭合元件的盖体形状可以设计成类似于第二闭合元件6'的形状。The shape of the cover of the closing element of the second groove 25 can be designed to be similar to the shape of the second closing element 6 ′.
在预备心脏泵的植入时,如图8所示,首先排气和润湿,然后通过导管或手柄26,将心脏泵4通过开口7拔出闭合的第一接纳空间3,并拖入到位于第一接纳空间外部的护套元件中。由此,泵4被径向压缩。此后,就能可靠地保持在护套元件11中,并以受保护的方式,免被使用者接触。In preparation for implantation of the heart pump, as shown in FIG8 , the heart pump 4 is first vented and moistened, and then the heart pump 4 is pulled out of the closed first receiving space 3 through the opening 7 using a catheter or handle 26 and pulled into the sheath element located outside the first receiving space. This radially compresses the pump 4. Thereafter, it is securely held in the sheath element 11 and protected from contact by the user.
在从第一接纳空间拔出之前,可以先对泵4进行试操作,方式为让冲洗流体从位于手柄区域中的冲洗系统开始流动,通过冲洗开口,经由导管8到达泵,此后该泵通过柔性驱动轴,以与操作速度相比显着降低的速度被驱动。Before being pulled out of the first receiving space, the pump 4 can be tested by letting the irrigation fluid flow from the irrigation system located in the area of the handle through the irrigation opening and via the conduit 8 to the pump, which is then driven via the flexible drive shaft at a speed that is significantly reduced compared to the operating speed.
在图10中,以三维形式表示了与在图9中以截面形式表示的结构相类似的结构。In FIG. 10 , a structure similar to that shown in cross section in FIG. 9 is shown in three dimensions.
容器1、1'、1”(或11”',见图11b)借助本发明和所述方式,可以确保心脏泵在植入时的高可用性和操作可靠性以及无菌性。The container 1 , 1 ′, 1 ″ (or 11 ″′, see FIG. 11 b ) can ensure high availability and operational reliability as well as sterility of the heart pump during implantation by means of the invention and in the manner described.
图11a和11b示出了接纳空间的进一步的实施例。在图11a中,首先示出了接纳空间,上面的接合部位9沿水平方向设置(在沟道13的方向或相应的导管的方向上)。与此垂直地设置了附加的接合部位9'。接合部位9和9'可以单独提供,也可同时提供。相应地提供了闭合元件5”和6”。在右侧(与开口7相对)设置有还一个开口7a”',其直径远大于开口7。其大小尺寸使得心脏泵可以在扩张的或稍微压缩的状态7a”下通过该开口被拖入。然而,在开口7a”闭合之后,心脏泵就只能在压缩状态下通过开口7拔出。对于这种情况,可以在开口7a”上设置不能以免破坏的方式释放的盖体。另选地,还可以构思能够免破坏取下的盖体(例如用于制造商检修)。接纳空间3”或盛接盆14”将根据上述实施例进行设计。这同样适用于其余已经讨论过的元件(例如沟道13、导管8、心脏泵4等)。Figures 11a and 11b show further embodiments of the receiving space. In Figure 11a, the receiving space is first shown, with the upper connection point 9 arranged horizontally (in the direction of the channel 13 or the corresponding conduit). An additional connection point 9' is arranged perpendicular to this. The connection points 9 and 9' can be provided separately or simultaneously. Closing elements 5" and 6" are provided accordingly. On the right side (opposite the opening 7), a further opening 7a"' is provided, the diameter of which is much larger than that of the opening 7. Its size allows the heart pump to be pulled in through this opening in the expanded or slightly compressed state 7a". However, after the opening 7a" is closed, the heart pump can only be pulled out through the opening 7 in the compressed state. For this case, a cover that cannot be released in a non-destructive manner can be provided on the opening 7a". Alternatively, a cover that can be removed in a non-destructive manner (for example for manufacturer maintenance) can also be conceived. The receiving space 3" or the receiving basin 14" will be designed according to the above-mentioned embodiment. The same applies to the other elements already discussed (such as the channel 13, the conduit 8, the heart pump 4, etc.).
图11b示出了又一个实施例,其与图11a的不同之处在于,这里只有一个接合部位9”。此外,下部闭合元件(在此用5'表示)被设计为减少了实心部分。盛接盆14"'或接纳空间3"'则基本如前文所述,同样如前的还有开口7、沟道13以及要送入接纳空间的导管或心脏泵。在图11b中示出了盖体(交叉阴影线部分),且该盖体不能以免破坏的方式从闭合件5”、6"'上松开。在图11b中示出的实施例中,例示了已经容纳在接纳空间3”'中的心脏泵4。这里可以清楚地看到,心脏泵可以通过开口7a””进入接纳空间,但只能以压缩状态通过开口7取出。在图11a和11b中所示的实施例当然也可以没有第二开口或盖体,则在这种情况下,开口7是接纳空间3'和3"'的唯一开口。在图11b中,至少指示出了心脏泵4以扩张状态放置在接纳空间中,并且该扩张状态所具有的直径使得泵能够基本上无压缩地通过开口7a”,但只能在压缩时才能通过开口7。FIG11 b shows a further embodiment, which differs from FIG11 a in that there is only one joint 9". In addition, the lower closure element (here indicated by 5') is designed with a reduced solid part. The receiving basin 14'" or the receiving space 3'" is then essentially as described above, with the same opening 7, the channel 13 and the catheter or heart pump to be introduced into the receiving space. FIG11 b shows a cover (cross-hatched part) which cannot be released from the closure 5", 6'" in a way that does not prevent damage. In the embodiment shown in FIG11 b, a heart pump 4 is illustrated which is already accommodated in the receiving space 3'". It can be clearly seen here that the heart pump can enter the receiving space through the opening 7a'", but can only be removed through the opening 7 in a compressed state. The embodiment shown in Figures 11a and 11b can of course also be without a second opening or a cover, in which case the opening 7 is the only opening in the receiving spaces 3' and 3'". In Figure 11b, at least the heart pump 4 is indicated as being placed in the receiving space in an expanded state and having a diameter such that the pump can pass through the opening 7a'' essentially without compression, but can only pass through the opening 7 when compressed.
在某些情况下,可以先不组装手柄部26,直到心脏泵已经进入接纳空间3、3'、3”、3”'之后再组装。组装好手柄之后,唯有按前述方式移除心脏泵,方可不造成破坏。In some cases, the handle portion 26 may not be assembled until the heart pump has entered the receiving space 3, 3', 3", 3'". After the handle has been assembled, the heart pump can only be removed without causing damage in the manner described above.
Claims (27)
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP15150897.5 | 2015-01-13 |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| HK1237286A1 HK1237286A1 (en) | 2018-04-13 |
| HK1237286B true HK1237286B (en) | 2021-08-13 |
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