技术领域Technical field
本发明涉及医疗器械技术领域，更具体地说，涉及一种输送鞘和介入式血泵输送系统。The present invention relates to the technical field of medical devices, and more specifically, to a delivery sheath and an interventional blood pump delivery system.
背景技术Background technique
介入式导管泵又称介入式血泵(以下简称血泵)，多用于高危经皮冠状动脉介入治疗(PCI)，血泵可减少心室作功、为心脏恢复和早期评估残余心肌功能提供必要的循环支持。此类泵血辅助装置需要经皮穿刺通过血管导入患者心脏，为了减小介入穿刺口并发症发生的概率并减轻患者的痛苦，血泵在穿刺口处有较小的尺寸。Interventional catheter pumps, also known as interventional blood pumps (hereinafter referred to as blood pumps), are mostly used in high-risk percutaneous coronary intervention (PCI). Blood pumps can reduce ventricular work, provide necessary energy for cardiac recovery and early assessment of residual myocardial function. Loop support. This type of blood pumping auxiliary device requires percutaneous puncture to be introduced into the patient's heart through blood vessels. In order to reduce the probability of complications at the interventional puncture port and relieve the patient's pain, the blood pump has a smaller size at the puncture port.
对于不用导丝引导介入的血泵，需要使用输送鞘介入。血泵的介入过程一般是利用介入鞘构建出连通血管和外部环境的通道，介入鞘的远端经过穿刺口放置在血管内，近端留在人体外；血泵导管收进输送鞘内且可以前后滑动，输送鞘连同血泵导管一起插入介入鞘并进入到血管中，继续推送血泵导管可以将血泵沿着血管放至心室内的工作位置。For blood pumps that do not use guidewires for intervention, a delivery sheath is required for intervention. The interventional process of the blood pump generally uses an interventional sheath to build a channel that connects the blood vessel and the external environment. The distal end of the interventional sheath is placed in the blood vessel through the puncture port, and the proximal end remains outside the body; the blood pump catheter is retracted into the delivery sheath and can Slide forward and backward, insert the delivery sheath together with the blood pump catheter into the interventional sheath and enter the blood vessel. Continue pushing the blood pump catheter to place the blood pump along the blood vessel to the working position in the ventricle.
结合图1，现有技术中的泵头可径向扩张的介入式血泵100的血泵导管包括手柄110、介入导管120、电机130、泵血导管140、入口保护支架150和猪尾导管160，该血泵导管的远端直径大，近端直径小，其中，泵血导管140需要使用输送鞘将扩张部分的泵头收折起来，然后一起插入介入鞘进入血管中。1 , the blood pump catheter of an interventional blood pump 100 with a radially expandable pump head in the prior art includes a handle 110, an interventional catheter 120, a motor 130, a blood pumping catheter 140, an inlet protection bracket 150 and a pigtail catheter 160. The distal diameter of the blood pump catheter is large and the proximal diameter is small. The blood pump catheter 140 needs to use a delivery sheath to fold up the expanded pump head, and then insert the interventional sheath into the blood vessel together.
针对上述泵头可径向扩张的血泵，如果使用普通的输送鞘，在血泵提供长时间的心脏辅助时，穿刺口需要保持在一个较大的直径，容易引起穿刺口的并发症，增加患者痛苦。且输送鞘的内壁与血泵的介入导管外壁之间会存在一个很大的间隙，血液流入并停滞在该间隙中会导致凝血，产生的血栓一旦流入患者血管中会引起栓塞甚至中风。For the above-mentioned blood pumps with radially expandable pump heads, if an ordinary delivery sheath is used, the puncture port needs to be kept at a larger diameter when the blood pump provides long-term cardiac assistance, which may easily cause puncture port complications and increase The patient is in pain. There will be a large gap between the inner wall of the delivery sheath and the outer wall of the interventional catheter of the blood pump. Blood flowing into and stagnating in this gap will cause coagulation. Once the generated thrombus flows into the patient's blood vessel, it may cause embolism or even stroke.
因此，如何将外径不一致的血泵导管顺利的放置于心室内的工作位置，同时在血泵长时间提供心脏辅助的时候，保持穿刺口在一个较小的尺寸，成为本领域技术人员亟待解决的技术问题。Therefore, how to smoothly place blood pump catheters with inconsistent outer diameters at the working position in the ventricle, and at the same time keep the puncture port in a smaller size when the blood pump provides cardiac assistance for a long time, has become an urgent problem for those skilled in the art. technical issues.
发明内容Contents of the invention
有鉴于此，本发明的目的在于提供一种输送鞘，以将外径不一致的血泵导管顺利的放置于心室内的工作位置，同时在血泵长时间提供心脏辅助的时候，保持穿刺口在一个较小的尺寸。In view of this, the object of the present invention is to provide a delivery sheath that can smoothly place blood pump catheters with inconsistent outer diameters in the working position in the ventricle, and at the same time, keep the puncture port in place when the blood pump provides cardiac assistance for a long time. A smaller size.
本发明的另一目的在于提供一种介入式血泵输送系统，该介入式血泵输送系统包括上述的输送鞘。Another object of the present invention is to provide an interventional blood pump delivery system, which includes the above-mentioned delivery sheath.
为实现上述目的，本发明提供如下技术方案：In order to achieve the above objects, the present invention provides the following technical solutions:
一种输送鞘，用于输送介入式血泵，所述介入式血泵由近端向远端方向上包括连接的介入导管和泵头，所述泵头可收折，且收折后的最大外径大于所述介入导管的外径，其特征在于，包括变径输送鞘；A delivery sheath used to deliver an interventional blood pump. The interventional blood pump includes a connected interventional catheter and a pump head from the proximal end to the distal end. The pump head can be folded, and the maximum diameter after folding is The outer diameter is larger than the outer diameter of the interventional catheter, and is characterized in that it includes a variable-diameter delivery sheath;
所述变径输送鞘由近端向远端方向上包括连接的变径输送鞘近端管段和变径输送鞘远端管段，所述变径输送鞘远端管段的管径大于所述变径输送鞘近端管段的管径，所述变径输送鞘近端管段用于容纳所述介入导管，所述变径输送鞘远端管段用于容纳所述泵头。The variable-diameter delivery sheath includes a connected proximal tube section of the variable-diameter delivery sheath and a distal tube section of the variable-diameter delivery sheath from the proximal end to the distal end. The diameter of the distal tube section of the variable-diameter delivery sheath is larger than the diameter of the variable-diameter delivery sheath. The diameter of the proximal tube section of the delivery sheath, the proximal tube section of the variable-diameter delivery sheath is used to accommodate the interventional catheter, and the distal tube section of the variable-diameter delivery sheath is used to accommodate the pump head.
可选地，在上述的输送鞘中，还包括滑动封堵件，所述滑动封堵件可滑动的设置于所述变径输送鞘远端管段内，用于密封连接于所述介入导管和所述变径输送鞘远端管段之间，于所述滑动封堵件滑动的第一极限位置，所述滑动封堵件远端的端面与所述变径输送鞘远端管段远端的端面平齐。Optionally, the above-mentioned delivery sheath further includes a sliding blocking member slidably disposed in the distal section of the variable-diameter delivery sheath for sealing connection with the interventional catheter and the Between the distal section of the variable-diameter delivery sheath, at the first limit position of the sliding blocking member, the end surface of the distal end of the sliding blocking member and the end surface of the distal end of the distal section of the variable-diameter delivery sheath Flush.
可选地，在上述的输送鞘中，所述变径输送鞘近端管段和所述变径输送鞘远端管段之间连接有用于过渡的变径管段。Optionally, in the above-mentioned delivery sheath, a reducing tube section for transition is connected between the proximal tube section of the variable-diameter delivery sheath and the distal tube section of the variable-diameter delivery sheath.
可选地，在上述的输送鞘中，所述滑动封堵件的近端设置有过渡结构，于所述滑动封堵件滑动的第二极限位置，所述过渡结构位于所述变径管段内。Optionally, in the above-mentioned delivery sheath, the proximal end of the sliding blocking member is provided with a transition structure, and at the second extreme position of the sliding blocking member, the transition structure is located in the reducing tube section. .
可选地，在上述的输送鞘中，所述滑动封堵件通过限位绳缆限制于所述变径输送鞘远端管段内滑动的第一极限位置；Optionally, in the above-mentioned delivery sheath, the sliding blocking member is limited to the first limit position of sliding in the distal section of the variable-diameter delivery sheath through a limiting cable;
所述限位绳缆的一端连接于所述变径管段，另一端连接于所述滑动封堵件的近端。One end of the limiting cable is connected to the reducing pipe section, and the other end is connected to the proximal end of the sliding blocking member.
可选地，在上述的输送鞘中，所述限位绳缆为与所述滑动封堵件连接的多根。Optionally, in the above delivery sheath, the limiting cables are multiple ones connected to the sliding blocking member.
可选地，在上述的输送鞘中，所述滑动封堵件为硅胶、TPU或PEBAX材质；Optionally, in the above delivery sheath, the sliding blocking member is made of silicone, TPU or PEBAX;
或，所述滑动封堵件为镍钛合金制备的封堵支架。Or, the sliding blocking member is a blocking stent made of nickel-titanium alloy.
可选地，在上述的输送鞘中，所述变径输送鞘远端管段可在收缩状态和扩张状态之间切换；Optionally, in the above delivery sheath, the distal section of the variable diameter delivery sheath can be switched between a contracted state and an expanded state;
所述变径输送鞘远端管段处于收缩状态时，所述变径输送鞘远端管段的管径等于所述变径输送鞘近端管段的管径，用于容纳所述介入导管；When the distal section of the variable-diameter delivery sheath is in a contracted state, the diameter of the distal section of the variable-diameter delivery sheath is equal to the diameter of the proximal section of the variable-diameter delivery sheath for accommodating the interventional catheter;
所述变径输送鞘远端管段处于扩张状态时，所述变径输送鞘远端管段的管径大于所述变径输送鞘近端管段的管径，用于容纳所述泵头。When the distal section of the variable-diameter delivery sheath is in an expanded state, the diameter of the distal section of the variable-diameter delivery sheath is larger than the diameter of the proximal section of the variable-diameter delivery sheath for accommodating the pump head.
可选地，在上述的输送鞘中，所述变径输送鞘远端管段包括：Optionally, in the above delivery sheath, the distal section of the variable diameter delivery sheath includes:
输送鞘弹性管体，具有沿轴向的开口，所述泵头收折于所述变径输送鞘远端管段内时，所述输送鞘弹性管体的开口打开，所述变径输送鞘远端管段处于扩张状态；所述泵头由所述变径输送鞘远端管段内释放后，所述输送鞘弹性管体开口两侧的导管壁重叠，所述变径输送鞘远端管段处于收缩状态；The elastic tube body of the delivery sheath has an opening along the axial direction. When the pump head is folded into the distal section of the variable-diameter delivery sheath, the opening of the elastic tube body of the delivery sheath is opened, and the distal end of the variable-diameter delivery sheath is opened. The end tube section is in an expanded state; after the pump head is released from the distal section of the variable-diameter delivery sheath, the catheter walls on both sides of the elastic tube opening of the delivery sheath overlap, and the distal section of the variable-diameter delivery sheath is in a contracted state. state;
可伸缩内膜，可伸缩的连接于所述输送鞘弹性管体开口的两端。The stretchable inner membrane is stretchably connected to both ends of the opening of the elastic tube body of the delivery sheath.
一种介入式血泵输送系统，包括：An interventional blood pump delivery system, including:
输送鞘，为上述的输送鞘；The delivery sheath is the above-mentioned delivery sheath;
可撕裂介入鞘，所述输送鞘用于穿过所述可撕裂介入鞘。A tearable interventional sheath, and the delivery sheath is used to pass through the tearable interventional sheath.
本发明提供的输送鞘用于输送介入式血泵，介入式血泵由近端向远端方向上包括连接的介入导管和泵头，该泵头被压缩后可收折入输送鞘，且其收折后的最大外径仍大于介入导管的外径。该输送鞘包括变径输送鞘和滑动封堵件。变径输送鞘由近端向远端方向上包括连接的变径输送鞘近端管段和变径输送鞘远端管段，变径输送鞘远端管段的管径大于变径输送鞘近端管段的管径，变径输送鞘近端管段用于容纳介入导管，变径输送鞘远端管段用于容纳泵头。The delivery sheath provided by the invention is used to deliver an interventional blood pump. The interventional blood pump includes a connected interventional catheter and a pump head from the proximal end to the distal end. The pump head can be folded into the delivery sheath after being compressed, and its The maximum outer diameter after folding is still larger than the outer diameter of the interventional catheter. The delivery sheath includes a variable-diameter delivery sheath and a sliding blocking member. The variable-diameter delivery sheath includes a connected proximal tube section of the variable-diameter delivery sheath and a distal tube section of the variable-diameter delivery sheath from the proximal end to the distal end. The diameter of the distal tube section of the variable-diameter delivery sheath is larger than that of the proximal tube section of the variable-diameter delivery sheath. Tube diameter, the proximal section of the variable-diameter delivery sheath is used to accommodate the interventional catheter, and the distal section of the variable-diameter delivery sheath is used to accommodate the pump head.
在介入式血泵的泵头收折进变径输送鞘远端管段后，介入式血泵和输送鞘一同插入已经进入患者血管中的可撕裂介入鞘。输送鞘进入血管后从穿刺口处拔出可撕裂介入鞘，并在体外将可撕裂介入鞘撕开从输送鞘上撤离，此时，外径较小的变径输送鞘近端管段处于穿刺口处，使得穿刺口保持较小的孔径。After the pump head of the interventional blood pump is folded into the distal section of the variable-diameter delivery sheath, the interventional blood pump and the delivery sheath are inserted into the tearable interventional sheath that has entered the patient's blood vessel. After the delivery sheath enters the blood vessel, the tearable interventional sheath is pulled out from the puncture port, and the tearable interventional sheath is torn open and removed from the delivery sheath outside the body. At this time, the proximal section of the variable-diameter delivery sheath with a smaller outer diameter is at At the puncture port, the hole diameter of the puncture port is kept smaller.
相较于现有技术，本发明提供的输送鞘沿轴向的直径变化可适用于将外径不一致的介入式血泵顺利的放置于心室内的工作位置，实现对介入式血泵的输送，同时在介入式血泵长时间提供心脏辅助的时候，通过管径较小的变径输送鞘近端管段保持穿刺口在一个较小的尺寸，降低患者痛苦，通过管径较大的变径输送鞘远端管段容纳泵头，易于泵头的释放，并降低收折时泵头损伤的几率。Compared with the prior art, the change in diameter of the delivery sheath provided by the present invention along the axial direction can be used to successfully place interventional blood pumps with inconsistent outer diameters in the working position in the ventricle to achieve delivery of the interventional blood pump. At the same time, when the interventional blood pump provides cardiac assistance for a long time, the proximal section of the delivery sheath with a smaller diameter is used to keep the puncture port at a smaller size, reducing the patient's pain, and the delivery sheath with a larger diameter is used. The distal tube section of the sheath accommodates the pump head, making it easy to release the pump head and reducing the chance of damage to the pump head when folded.
本发明提供的介入式血泵输送系统包括上述的输送鞘和可撕裂介入鞘，输送鞘用于穿过可撕裂介入鞘。由于具有上述的介入式血泵输送系统，所以同样具有上述的结构和有益效果，在此不再赘述。The interventional blood pump delivery system provided by the present invention includes the above-mentioned delivery sheath and a tearable interventional sheath, and the delivery sheath is used to pass through the tearable interventional sheath. Since it has the above-mentioned interventional blood pump delivery system, it also has the above-mentioned structure and beneficial effects, which will not be described again here.
附图说明Description of the drawings
为了更清楚地说明本发明实施例或现有技术中的技术方案，下面将对实施例或现有技术描述中所需要使用的附图作简单地介绍，显而易见地，下面描述中的附图仅仅是本发明的一些实施例，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的附图。In order to explain the embodiments of the present invention or the technical solutions in the prior art more clearly, the drawings needed to be used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings in the following description are only These are some embodiments of the present invention. For those of ordinary skill in the art, other drawings can be obtained based on these drawings without exerting creative efforts.
图1为现有技术中介入式血泵的结构示意图；Figure 1 is a schematic structural diagram of an interventional blood pump in the prior art;
图2为本发明实施例公开的输送鞘的结构示意图；Figure 2 is a schematic structural diagram of a delivery sheath disclosed in an embodiment of the present invention;
图3为本发明实施例公开的输送鞘插入可撕裂介入鞘状态的示意图；Figure 3 is a schematic diagram of a state in which a tearable interventional sheath is inserted into a delivery sheath disclosed in an embodiment of the present invention;
图4为本发明实施例公开的输送鞘在收折泵血导管后进入可撕裂介入鞘的示意图；Figure 4 is a schematic diagram of the delivery sheath disclosed in the embodiment of the present invention entering the tearable interventional sheath after folding the blood pumping catheter;
图5为本发明实施例公开的泵血导管处于工作状态的输送鞘的示意图；Figure 5 is a schematic diagram of the delivery sheath of the blood pumping catheter disclosed in the embodiment of the present invention in a working state;
图6为本发明实施例公开的介入式血泵收鞘时滑动封堵件的位置示意图；Figure 6 is a schematic diagram of the position of the sliding blocking member when the interventional blood pump disclosed in the embodiment of the present invention is sheathed;
图7为本发明实施例公开的介入式血泵释放后滑动封堵件的位置示意图；Figure 7 is a schematic diagram of the position of the sliding blocking member after the interventional blood pump is released according to the embodiment of the present invention;
图8为本发明实施例公开的变径输送鞘远端管段处于收缩状态的结构示意图；Figure 8 is a schematic structural diagram of the distal tube section of the variable-diameter delivery sheath disclosed in the embodiment of the present invention in a contracted state;
图9为本发明实施例公开的变径输送鞘远端管段处于扩张状态的结构示意图。Figure 9 is a schematic structural diagram of the distal tube section of the variable-diameter delivery sheath disclosed in an embodiment of the present invention in an expanded state.
其中，100为介入式血泵，110为手柄，120为介入导管，130为电机，140为泵血导管，150为入口保护支架，160为猪尾导管；Among them, 100 is an interventional blood pump, 110 is a handle, 120 is an interventional catheter, 130 is a motor, 140 is a blood pumping catheter, 150 is an inlet protection bracket, and 160 is a pigtail catheter;
200为输送鞘，201为压盖，202为输送鞘接头，203为缝合垫，204为排气导管，205为三通阀，210为变径输送鞘，211为变径输送鞘近端管段，212为变径管段，213为变径输送鞘远端管段，220为滑动封堵件，221为限位绳缆，222为限位绳缆远端连接点，223为限位绳缆近端连接点，231为可伸缩内膜，232为输送鞘弹性管体；200 is a delivery sheath, 201 is a gland, 202 is a delivery sheath connector, 203 is a suture pad, 204 is an exhaust catheter, 205 is a three-way valve, 210 is a variable diameter delivery sheath, 211 is a variable diameter delivery sheath proximal section, 212 is a reducing pipe section, 213 is a distal section of the reducing delivery sheath, 220 is a sliding blocking member, 221 is a limiting cable, 222 is a distal connection point of the limiting cable, and 223 is a proximal connection of the limiting cable. Point, 231 is the stretchable intima, 232 is the elastic tube body of the delivery sheath;
300为可撕裂介入鞘。300 is a tearable interventional sheath.
具体实施方式Detailed ways
本发明的核心在于公开一种输送鞘，以将外径不一致的血泵导管顺利的放置于心室内的工作位置，同时在血泵长时间提供心脏辅助的时候，保持穿刺口在一个较小的尺寸。The core of the present invention is to disclose a delivery sheath that can smoothly place blood pump catheters with inconsistent outer diameters in the working position in the ventricle, and at the same time keep the puncture port in a smaller space when the blood pump provides cardiac assistance for a long time. size.
本发明的另一核心在于公开一种介入式血泵输送系统，该介入式血泵输送系统包括上述的输送鞘。Another core of the present invention is to disclose an interventional blood pump delivery system, which includes the above-mentioned delivery sheath.
以下，参照附图对实施例进行说明。此外，下面所示的实施例不对权利要求所记载的发明内容起任何限定作用。另外，下面实施例所表示的构成的全部内容不限于作为权利要求所记载的发明的解决方案所必需的。Hereinafter, embodiments will be described with reference to the drawings. In addition, the embodiments shown below do not limit the invention described in the claims in any way. In addition, all the contents of the structures shown in the following examples are not limited to what is necessary as a solution to the invention described in the claims.
其中，在本申请实施例的描述中，除非另有说明，“/”表示或的意思，例如，A/B可以表示A或B；本文中的“和/或”仅仅是一种描述关联对象的关联关系，表示可以存在三种关系，例如，A和/或B，可以表示：单独存在A，同时存在A和B，单独存在B这三种情况。另外，在本申请实施例的描述中，“多个”是指两个或多于两个。Among them, in the description of the embodiments of this application, unless otherwise stated, "/" means or, for example, A/B can mean A or B; "and/or" in this article is only a way to describe related objects. The association relationship means that there can be three relationships. For example, A and/or B can mean: A alone exists, A and B exist simultaneously, and B alone exists. In addition, in the description of the embodiments of this application, "plurality" refers to two or more than two.
以下，术语“第一”、“第二”仅用于描述目的，而不能理解为指示或暗示相对重要性或者隐含指明所指示的技术特征的数量。由此，限定有“第一”、“第二”的特征可以明示或者隐含地包括一个或者更多个该特征。Hereinafter, the terms “first” and “second” are used for descriptive purposes only and cannot be understood as indicating or implying relative importance or implicitly indicating the quantity of indicated technical features. Therefore, features defined as "first" and "second" may explicitly or implicitly include one or more of these features.
本发明实施例公开的输送鞘200用于输送介入式血泵100，结合图1，介入式血泵100由近端向远端方向上包括连接的介入导管120和泵头，该泵头被压缩后可收折入输送鞘200，且其收折后的最大外径仍大于介入导管120的外径。其中，泵头指包括电机130、泵血导管140、入口保护支架150和猪尾导管160在内的全部结构。The delivery sheath 200 disclosed in the embodiment of the present invention is used to deliver the interventional blood pump 100. With reference to Figure 1, the interventional blood pump 100 includes a connected interventional catheter 120 and a pump head from the proximal end to the distal end. The pump head is compressed It can then be folded into the delivery sheath 200, and its maximum outer diameter after folding is still larger than the outer diameter of the interventional catheter 120. Among them, the pump head refers to the entire structure including the motor 130, the blood pumping catheter 140, the inlet protection bracket 150 and the pigtail catheter 160.
该输送鞘200包括变径输送鞘210和滑动封堵件220。变径输送鞘210由近端向远端方向上包括连接的变径输送鞘近端管段211和变径输送鞘远端管段213，变径输送鞘远端管段213的管径大于变径输送鞘近端管段211的管径，变径输送鞘近端管段211用于容纳介入导管120，变径输送鞘远端管段213用于容纳泵头。The delivery sheath 200 includes a variable-diameter delivery sheath 210 and a sliding blocking member 220 . The variable-diameter delivery sheath 210 includes a connected variable-diameter delivery sheath proximal tube section 211 and a variable-diameter delivery sheath distal tube section 213 from the proximal end to the distal end. The diameter of the variable-diameter delivery sheath distal tube section 213 is larger than the variable-diameter delivery sheath. The diameter of the proximal tube section 211, the proximal tube section 211 of the variable-diameter delivery sheath is used to accommodate the interventional catheter 120, and the distal tube section 213 of the variable-diameter delivery sheath is used to accommodate the pump head.
结合图3，在介入式血泵100的泵头收折进变径输送鞘远端管段213后，介入式血泵100和输送鞘200一同插入已经进入患者血管中的可撕裂介入鞘300。输送鞘200进入血管后从穿刺口处拔出可撕裂介入鞘300，并在体外将可撕裂介入鞘300撕开从输送鞘200上撤离，此时，外径较小的变径输送鞘近端管段211处于穿刺口处，使得穿刺口保持较小的孔径。3 , after the pump head of the interventional blood pump 100 is folded into the distal section 213 of the variable-diameter delivery sheath, the interventional blood pump 100 and the delivery sheath 200 are inserted into the tearable interventional sheath 300 that has entered the patient's blood vessel. After the delivery sheath 200 enters the blood vessel, the tearable interventional sheath 300 is pulled out from the puncture port, and the tearable interventional sheath 300 is torn open and removed from the delivery sheath 200 outside the body. At this time, the variable-diameter delivery sheath with a smaller outer diameter is The proximal tube section 211 is located at the puncture port so that the puncture port maintains a smaller aperture.
相较于现有技术，本发明实施例公开的输送鞘200沿轴向的直径变化可适用于将外径不一致的介入式血泵100顺利的放置于心室内的工作位置，实现对介入式血泵100的输送，同时在介入式血泵100长时间提供心脏辅助的时候，通过管径较小的变径输送鞘近端管段211保持穿刺口在一个较小的尺寸，降低患者痛苦，通过管径较大的变径输送鞘远端管段213容纳泵头，易于泵头的释放，并降低收折时泵头损伤的几率。Compared with the prior art, the change in diameter of the delivery sheath 200 disclosed in the embodiment of the present invention in the axial direction can be used to successfully place the interventional blood pump 100 with inconsistent outer diameters in the working position in the ventricle, thereby realizing the control of the interventional blood pump. During the delivery of the pump 100, when the interventional blood pump 100 provides cardiac assistance for a long time, the proximal tube section 211 of the variable-diameter delivery sheath with a smaller diameter keeps the puncture port in a smaller size, reducing the patient's pain. The distal pipe section 213 of the variable-diameter delivery sheath with a larger diameter accommodates the pump head, making it easy to release the pump head and reducing the probability of damage to the pump head when folded.
需要说明的是，以下血泵导管指包括介入导管120、电机130、泵血导管140、入口保护支架150和猪尾导管160在内的全部结构。It should be noted that the following blood pump catheter refers to all structures including the interventional catheter 120, the motor 130, the blood pump catheter 140, the inlet protection bracket 150 and the pigtail catheter 160.
当介入式血泵100的泵头端(以下简称血泵头端)从输送鞘200中释放出来，此时变径输送鞘远端管段213的内壁和介入导管120的外壁之间会存在一个较大的间隙，血液进入后滞留在该间隙中会导致凝血，为了避免出现凝血现象，在本发明公开的一具体的实施例中，输送鞘200还包括滑动封堵件220。When the pump head end of the interventional blood pump 100 (hereinafter referred to as the blood pump head end) is released from the delivery sheath 200, there will be a gap between the inner wall of the distal section 213 of the variable-diameter delivery sheath and the outer wall of the interventional catheter 120. A large gap will cause coagulation after blood enters and remains in the gap. In order to avoid coagulation, in a specific embodiment disclosed in the present invention, the delivery sheath 200 further includes a sliding blocking member 220 .
滑动封堵件220可滑动的设置于变径输送鞘远端管段213内，用于密封连接于介入导管120和变径输送鞘远端管段213之间，且于滑动封堵件220滑动的第一极限位置，滑动封堵件220的远端端面与变径输送鞘远端管段213远端的端面平齐，以避免血液进入变径输送鞘远端管段213。The sliding blocking member 220 is slidably disposed in the distal section 213 of the variable-diameter delivery sheath for sealing connection between the interventional catheter 120 and the distal section 213 of the variable-diameter delivery sheath. In an extreme position, the distal end surface of the sliding blocking member 220 is flush with the distal end surface of the variable-diameter delivery sheath distal tube section 213 to prevent blood from entering the variable-diameter delivery sheath distal tube section 213 .
通过滑动封堵件220可以对介入导管120和变径输送鞘远端管段213之间的间隙进行封堵，且滑动封堵件220的滑动可使滑动封堵件220滑动至变径输送鞘远端管段213的远端开口处，以将血液封堵于变径输送鞘远端管段213之外，使血液不能回流至输送鞘200内滞留产生凝血。The gap between the interventional catheter 120 and the distal section 213 of the variable-diameter delivery sheath can be blocked by the sliding blocking member 220, and the sliding of the sliding blocking member 220 can cause the sliding blocking member 220 to slide to the distal end of the variable-diameter delivery sheath. The distal opening of the end tube section 213 is used to block the blood outside the distal tube section 213 of the variable-diameter delivery sheath, so that the blood cannot flow back into the delivery sheath 200 and remain there to cause coagulation.
其中，滑动封堵件220的内径略大于或等于介入导管120的外径，外径略小于或等于变径输送鞘远端管段213的内径。The inner diameter of the sliding blocking member 220 is slightly larger than or equal to the outer diameter of the interventional catheter 120 , and the outer diameter is slightly smaller than or equal to the inner diameter of the distal section 213 of the variable-diameter delivery sheath.
结合图2，变径输送鞘近端管段211的内径略大于介入导管120的外径，以使二者之间基本不存在间隙，在通过排气导管204灌注生理盐水后，血液不会进入该间隙中。2, the inner diameter of the proximal section 211 of the variable-diameter delivery sheath is slightly larger than the outer diameter of the interventional catheter 120, so that there is basically no gap between the two. After the physiological saline is perfused through the exhaust catheter 204, blood will not enter the catheter. in the gap.
在变径输送鞘近端管段211和变径输送鞘远端管段213之间连接有用于过渡的变径管段212。A reducing tube section 212 for transition is connected between the proximal tube section 211 of the reducing delivery sheath and the distal tube section 213 of the reducing delivery sheath.
结合图6，滑动封堵件220的近端设置有过渡结构，于滑动封堵件220滑动的第二极限位置，过渡结构位于变径管段212内。血泵收折在变径输送鞘远端管段213的内腔中，受变径管段212的尺寸限制，血泵收折时推动滑动封堵件220处在第二极限位置。Referring to FIG. 6 , a transition structure is provided at the proximal end of the sliding blocking member 220 . At the second limit position of the sliding blocking member 220 , the transition structure is located in the reducing pipe section 212 . The blood pump is folded in the inner cavity of the distal pipe section 213 of the variable-diameter delivery sheath. Limited by the size of the variable-diameter pipe section 212, when the blood pump is folded, the sliding blocking member 220 is pushed to the second extreme position.
在本发明公开的一具体的实施例中，滑动封堵件220通过限位绳缆221限制于变径输送鞘远端管段213内滑动的第一极限位置。In a specific embodiment disclosed in the present invention, the sliding blocking member 220 is limited to the first limit position of sliding in the distal tube section 213 of the variable-diameter delivery sheath through the limiting cable 221 .
在输送鞘200输入至血管的初始状态下，滑动封堵件220位于初始位置/第二极限位置，并位于电机130的近端，结合图7，当血泵头端从介入鞘中释放出来，并沿输送鞘200进行移动时，滑动封堵件220先随介入导管120在变径输送鞘远端管段213内滑动，直至被限位绳缆221限制于第一极限位置。In the initial state when the delivery sheath 200 is input into the blood vessel, the sliding blocking member 220 is located at the initial position/second extreme position and is located at the proximal end of the motor 130. With reference to Figure 7, when the blood pump head end is released from the interventional sheath, When moving along the delivery sheath 200, the sliding blocking member 220 first slides with the interventional catheter 120 in the distal section 213 of the variable-diameter delivery sheath until it is limited to the first limit position by the limiting cable 221.
结合图5，限位绳缆221的一端(限位绳缆近端连接点223)连接于变径管段212，另一端(限位绳缆远端连接点222)连接于滑动封堵件220的近端。变径管段212的结构可对柔性线材构成的限位绳缆221进行收纳。5, one end of the limiting cable 221 (the proximal connection point 223 of the limiting cable) is connected to the reducing pipe section 212, and the other end (the distal connection point 222 of the limiting cable) is connected to the sliding blocking member 220. near end. The structure of the reducing pipe section 212 can accommodate the limiting cable 221 composed of flexible wires.
具体地，变径管段212一般由内层的PTFE结构、中间层的不锈钢弹簧或编织网、以及外层的PEBAX或TPU结构构成，限位缆绳221一般与变径管段212中间层的不锈钢弹簧或编织网结构连接。Specifically, the reducing pipe section 212 is generally composed of an inner layer of PTFE structure, a middle layer of stainless steel springs or braided mesh, and an outer layer of PEBAX or TPU structure. The limiting cable 221 is generally connected to the middle layer of the reducing pipe section 212 with a stainless steel spring or braided mesh. Woven mesh structural connections.
结合图4～图7，当血泵头端从输送鞘200中释放后开始辅助心脏时，由于受到介入导管120向变径输送鞘远端管段213远端推送的力，滑动封堵件220从收折时处于变径管段212的位置(第二极限位置)，滑动至变径输送鞘远端管段213远端出口的位置(第一极限位置)，此时限位绳缆221处于绷紧状态，限位绳缆221限制住滑动封堵件220向变径输送鞘远端管段213外的滑动，避免从变径输送鞘远端管段213内脱出。4 to 7 , when the blood pump head is released from the delivery sheath 200 and starts to assist the heart, due to the force pushed by the interventional catheter 120 to the distal end of the variable-diameter delivery sheath distal section 213, the sliding blocking member 220 is pushed from When folded, it is at the position of the reducing pipe section 212 (the second limit position) and slides to the position of the distal outlet of the distal pipe section 213 of the variable diameter delivery sheath (the first limit position). At this time, the limiting cable 221 is in a tight state. The limiting cable 221 restricts the sliding blocking member 220 from sliding out of the distal section 213 of the variable-diameter delivery sheath to prevent it from protruding from the distal section 213 of the variable-diameter delivery sheath.
其中，图7所示为血泵导管收折进鞘之前或血泵释放之后的状态，也是输送鞘200制作时的定型状态。Among them, FIG. 7 shows the state before the blood pump catheter is folded into the sheath or after the blood pump is released. It is also the finalized state when the delivery sheath 200 is manufactured.
在滑动封堵件220由第二极限位置向第一极限位置滑动的过程中，可向变径输送鞘远端管段213和介入导管120之间灌注生理盐水，以推动滑动封堵件220的滑动。When the sliding blocking member 220 slides from the second extreme position to the first limiting position, physiological saline can be injected between the distal section 213 of the variable-diameter delivery sheath and the interventional catheter 120 to promote the sliding movement of the sliding blocking member 220 .
在输送鞘200的制备过程中，在将变径管段212和变径输送鞘远端管段213连接之前，可以先将限位绳缆221固定于变径管段212和滑动封堵件220上，然后再进行变径管段212和变径输送鞘远端管段213的连接，以及变径管段212和变径输送鞘近端管段211的连接。During the preparation process of the delivery sheath 200, before connecting the reducing tube section 212 and the distal section 213 of the reducing delivery sheath, the limiting cable 221 can be fixed on the reducing tube section 212 and the sliding blocking member 220, and then Then the reducing pipe section 212 is connected to the distal section 213 of the reducing delivery sheath, and the reducing pipe section 212 is connected to the proximal section 211 of the reducing delivery sheath.
其中，限位绳缆221为与滑动封堵件220连接的多根，限位绳缆221可以沿滑动封堵件220的周向均匀布置，或为对称设置于滑动封堵件220的两根。Among them, the limiting cables 221 are multiple ones connected to the sliding blocking member 220. The limiting cables 221 can be evenly arranged along the circumferential direction of the sliding blocking member 220, or they can be two symmetrically arranged on the sliding blocking member 220. .
滑动封堵件220在变径输送鞘远端管段213内的滑动限位还可以通过其他结构来实现，例如在变径管段212的远端开口处设置限位部，该限位部可供介入式血泵100穿过，但滑动封堵件220会被该限位部限位，无法由变径输送鞘远端管段213处脱出。但该方案会导致变径输送鞘远端管段213的外径进行一定的扩大，进而导致可撕裂介入鞘300的尺寸扩大，会增加穿刺口的尺寸，给患者带来更多的痛苦。The sliding limitation of the sliding blocking member 220 in the distal section 213 of the variable-diameter delivery sheath can also be achieved through other structures. For example, a limiting portion is provided at the distal opening of the variable-diameter delivery sheath 212, which can be used for intervention. The blood pump 100 passes through, but the sliding blocking member 220 will be limited by the limiting portion and cannot escape from the distal section 213 of the variable-diameter delivery sheath. However, this solution will cause the outer diameter of the distal section 213 of the variable-diameter delivery sheath to expand to a certain extent, which will in turn cause the size of the tearable interventional sheath 300 to expand, which will increase the size of the puncture port and bring more pain to the patient.
滑动封堵件220可以由柔性材料构成，例如硅胶、TPU(热塑性聚氨酯弹性体橡胶)、PEBAX(尼龙弹性体)等医用级材料。滑动封堵件220也可以是由镍钛合金定型而成的封堵支架，或是镍钛合金丝编织而成的封堵支架。封堵支架的内径略大于介入导管120的外径，通过封堵支架的径向支撑力可自动与变径输送鞘远端管段213的内壁相贴合，且不影响其封堵效果。The sliding blocking member 220 may be made of flexible materials, such as silicone, TPU (thermoplastic polyurethane elastomer rubber), PEBAX (nylon elastomer) and other medical grade materials. The sliding blocking member 220 may also be a blocking stent shaped by nickel-titanium alloy, or a blocking stent made of braided nitinol alloy wires. The inner diameter of the blocking stent is slightly larger than the outer diameter of the interventional catheter 120. The radial support force of the blocking stent can automatically fit the inner wall of the distal section 213 of the variable-diameter delivery sheath without affecting its blocking effect.
结合图8和图9，在本发明公开的另一具体的实施例中，变径输送鞘远端管段213可在收缩状态和扩张状态之间切换，变径输送鞘远端管段213处于收缩状态时，变径输送鞘远端管段213的管径等于或略大于变径输送鞘近端管段211的管径，用于与介入导管120的外壁贴合，进行对介入导管120的容纳，变径输送鞘远端管段213处于扩张状态时，变径输送鞘远端管段213的管径大于变径输送鞘近端管段211的管径，用于与泵头的外壁贴合，进行对泵头的容纳。8 and 9 , in another specific embodiment disclosed by the present invention, the distal section 213 of the variable-diameter delivery sheath can be switched between a contracted state and an expanded state, and the distal section 213 of the variable-diameter delivery sheath is in a contracted state. When the diameter of the distal section 213 of the variable-diameter delivery sheath is equal to or slightly larger than the diameter of the proximal section 211 of the variable-diameter delivery sheath, it is used to fit with the outer wall of the interventional catheter 120 to accommodate the interventional catheter 120. When the distal section 213 of the delivery sheath is in the expanded state, the diameter of the distal section 213 of the variable-diameter delivery sheath is larger than the diameter of the proximal section 211 of the variable-diameter delivery sheath, and is used to fit with the outer wall of the pump head to perform the pump head. accommodate.
本发明实施例公开的输送鞘200通过将变径输送鞘远端管段213设置为可以径向扩张和收缩的变径导管，使得可适用于电机130内置且泵头可径向收折的介入式血泵100的输送，变径输送鞘远端管段213在收缩状态和扩张状态之间的切换可保证其始终与介入式血泵100的外壁相贴合，从而将血液封堵于输送鞘200之外，避免凝血现象的发生。The delivery sheath 200 disclosed in the embodiment of the present invention sets the distal section 213 of the variable-diameter delivery sheath as a variable-diameter catheter that can be expanded and contracted radially, so that it can be applied to an interventional type in which the motor 130 is built-in and the pump head can be radially folded. During the delivery of the blood pump 100, the switching of the distal section 213 of the variable-diameter delivery sheath between the contracted state and the expanded state ensures that it is always in contact with the outer wall of the interventional blood pump 100, thereby blocking the blood between the delivery sheath 200. In addition, avoid the occurrence of blood coagulation.
具体地，变径输送鞘远端管段213包括输送鞘弹性管体232和可伸缩内膜231。输送鞘弹性管体232具有沿轴向的开口，在泵头收折于变径输送鞘远端管段213内时，输送鞘弹性管体232的开口打开，变径输送鞘近端管段211处于扩张状态；泵头由变径输送鞘远端管段213内释放后，输送鞘弹性管体232开口两侧的导管壁部分重叠，变径输送鞘近端管段211处于收缩。通过输送鞘弹性管体232变径输送鞘远端管段213可在收缩状态和扩张状态之间切换。可伸缩内膜231可伸缩的连接于输送鞘弹性管体232开口的两端，以随变径输送鞘远端管段213在收缩状态和扩张状态之间切换，进行伸缩，并与输送鞘弹性管体232构成完整的管侧壁。Specifically, the variable-diameter delivery sheath distal tube section 213 includes a delivery sheath elastic tube 232 and a stretchable inner membrane 231 . The elastic tube body 232 of the delivery sheath has an opening along the axial direction. When the pump head is folded into the distal section 213 of the variable-diameter delivery sheath, the opening of the elastic tube body 232 of the delivery sheath is opened, and the proximal section 211 of the variable-diameter delivery sheath is in an expanded state. Status: After the pump head is released from the distal section 213 of the variable-diameter delivery sheath, the catheter walls on both sides of the opening of the elastic tube 232 of the delivery sheath partially overlap, and the proximal section 211 of the variable-diameter delivery sheath is contracted. The distal section 213 of the delivery sheath can be switched between a contracted state and an expanded state through the delivery sheath elastic tube body 232. The stretchable inner membrane 231 is telescopically connected to both ends of the opening of the delivery sheath elastic tube 232 to switch between the contracted state and the expanded state as the variable-diameter delivery sheath distal tube section 213 switches between the contracted state and the expanded state, and communicates with the delivery sheath elastic tube. Body 232 forms the complete tube side wall.
通过血泵头端的径向力将变径输送鞘远端管段213撑开达到扩张状态，待血泵头端释放出输送鞘200后，变径输送鞘远端管段213拥有一个自发的向内收缩的径向力，重新恢复到图8所示的收折状态，此时输送鞘弹性管体232内壁紧贴于介入导管120的外壁，变径输送鞘近端管段211和变径输送鞘远端管段213的内径几乎保持一致，以极大减小输送鞘200和介入导管120之间的间隙。The distal section 213 of the variable-diameter delivery sheath is stretched to an expanded state by the radial force at the head end of the blood pump. After the head-end of the blood pump releases the delivery sheath 200, the distal section 213 of the variable-diameter delivery sheath has a spontaneous inward contraction. The radial force returns to the folded state shown in Figure 8. At this time, the inner wall of the elastic tube body 232 of the delivery sheath is close to the outer wall of the interventional catheter 120, and the proximal section 211 of the variable-diameter delivery sheath and the distal end of the variable-diameter delivery sheath The inner diameter of the tube section 213 remains almost uniform to greatly reduce the gap between the delivery sheath 200 and the interventional catheter 120 .
其中，输送鞘弹性管体232由具有弹性的高分子材料构成，可伸缩内膜231为PTFE(聚四氟乙烯材质)的内膜。The delivery sheath elastic tube body 232 is made of elastic polymer material, and the stretchable inner membrane 231 is an inner membrane made of PTFE (polytetrafluoroethylene).
输送鞘200还包括输送鞘接头202、压盖201和缝合垫203等结构，输送鞘接头202连接于变径输送鞘近端管段211的近端，并通过排气导管204连接有三通阀205，压盖201与输送鞘接头202的近端连接，缝合垫203设置于输送鞘接头202外壁上。此为现为技术，在此不再赘述。The delivery sheath 200 also includes a delivery sheath connector 202, a gland 201, a suture pad 203 and other structures. The delivery sheath connector 202 is connected to the proximal end of the variable-diameter delivery sheath proximal pipe section 211, and is connected to a three-way valve 205 through the exhaust conduit 204. The gland 201 is connected to the proximal end of the delivery sheath connector 202, and the suture pad 203 is disposed on the outer wall of the delivery sheath connector 202. This is a current technology and will not be described in detail here.
本发明实施例公开的介入式血泵输送系统包括上述的输送鞘200和可撕裂介入鞘300，输送鞘200用于穿过可撕裂介入鞘300。由于具有上述的介入式血泵输送系统，所以同样具有上述的结构和有益效果，在此不再赘述。The interventional blood pump delivery system disclosed in the embodiment of the present invention includes the above-mentioned delivery sheath 200 and a tearable interventional sheath 300. The delivery sheath 200 is used to pass through the tearable interventional sheath 300. Since it has the above-mentioned interventional blood pump delivery system, it also has the above-mentioned structure and beneficial effects, which will not be described again here.
其中，可撕裂介入鞘300在输送鞘200进入血管后可以撤出可撕裂介入鞘300，利用可撕鞘手柄掰开沿轴向撕裂，并从输送鞘200上剥离。Among them, the tearable interventional sheath 300 can be withdrawn after the delivery sheath 200 enters the blood vessel, and the tearable interventional sheath 300 can be opened by the tearable sheath handle to tear along the axial direction, and peeled off from the delivery sheath 200 .
本发明的说明书和权利要求书中的术语“第一”和“第二”等是用于区别不同的对象，而不是用于描述特定的顺序。此外术语“包括”和“具有”以及他们任何变形，意图在于覆盖不排他的包含。例如包含了一系列步骤或单元的过程、方法、系统、产品或设备没有设定于已列出的步骤或单元，而是可包括没有列出的步骤或单元。The terms "first", "second", etc. in the description and claims of the present invention are used to distinguish different objects, rather than describing a specific sequence. In addition, the terms "including" and "having" and any variations thereof are intended to cover non-exclusive inclusion. For example, a process, method, system, product, or device that includes a series of steps or units is not configured with the listed steps or units, but may include steps or units that are not listed.
对所公开的实施例的上述说明，使本领域专业技术人员能够实现或使用本发明。对这些实施例的多种修改对本领域的专业技术人员来说将是显而易见的，本文中所定义的一般原理可以在不脱离本发明的精神或范围的情况下，在其它实施例中实现。因此，本发明将不会被限制于本文所示的这些实施例，而是要符合与本文所公开的原理和新颖特点相一致的最宽的范围。The above description of the disclosed embodiments enables those skilled in the art to make or use the present invention. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the generic principles defined herein may be practiced in other embodiments without departing from the spirit or scope of the invention. Thus, the present invention is not intended to be limited to the embodiments shown herein but is to be accorded the widest scope consistent with the principles and novel features disclosed herein.
以上描述仅为本申请的较佳实施例以及对所运用技术原理的说明而已，并不用于限制本申请。对于本领域技术人员来说，本申请可以有各种更改和变化。本申请中所涉及的申请范围，并不限于上述技术特征的特定组合而成的技术方案，同时也应涵盖在不脱离上述申请构思的情况下，由上述技术特征或其等同特征进行任意组合而形成的其它技术方案。例如上述特征与本申请中公开的(但不限于)具有类似功能的技术特征进行互相替换而形成的技术方案。The above description is only a preferred embodiment of the present application and an explanation of the applied technical principles, and is not intended to limit the present application. To those skilled in the art, various modifications and variations may be made to this application. The scope of the application involved in this application is not limited to technical solutions formed by a specific combination of the above-mentioned technical features. It should also cover any combination of the above-mentioned technical features or their equivalent features without departing from the concept of the above-mentioned application. Other technical solutions formed. For example, a technical solution is formed by replacing the above features with technical features with similar functions disclosed in this application (but not limited to).
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202311000848.XACN116943017B (en) | 2023-08-09 | Conveying sheath and interventional blood pump conveying system |
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202311000848.XACN116943017B (en) | 2023-08-09 | Conveying sheath and interventional blood pump conveying system |
| Publication Number | Publication Date |
|---|---|
| CN116943017Atrue CN116943017A (en) | 2023-10-27 |
| CN116943017B CN116943017B (en) | 2025-10-17 |
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