技术领域Technical field
本发明涉及一种导管泵及折叠导管泵的泵头的方法，属于医疗器械领域。The invention relates to a catheter pump and a method for folding a pump head of the catheter pump, and belongs to the field of medical devices.
背景技术Background technique
导管泵适于被介入心衰患者心脏的期望位置中以辅助心脏的泵血功能。出于减轻病人痛苦和减少穿刺口并发症的角度出发，希望导管泵能以较小的尺寸介入人体。The catheter pump is adapted to be inserted into a desired location in the heart of a heart failure patient to assist the pumping function of the heart. From the perspective of alleviating patient pain and reducing complications at the puncture site, it is hoped that the catheter pump can be inserted into the human body in a smaller size.
导管泵的远端泵头为自膨胀展开结构，为了将其以较小的介入尺寸输送进人体血管内，需要在体外将泵头收折。目前，设计的方式是在导管泵的导管近端预装一根管状导入器，通过往泵头方向推送管状导入器将泵头收折至导入器管体内，但该操作过程中导入器有可能被误操作而使导入器从泵头远端滑脱，且由于医生操作习惯不同，有的医生会更习惯自远端向近端收折泵头，因此目前涉及的收折方式无法满足需求。The distal pump head of the catheter pump has a self-expanding structure. In order to deliver it into human blood vessels with a smaller intervention size, the pump head needs to be folded outside the body. At present, the design method is to pre-install a tubular introducer on the proximal end of the catheter of the catheter pump, and push the tubular introducer toward the pump head to fold the pump head into the introducer body. However, during this operation, the introducer has The introducer may slip from the distal end of the pump head due to misoperation, and due to different operating habits of doctors, some doctors are more accustomed to folding the pump head from the distal end to the proximal end, so the current folding method cannot meet the needs.
发明内容Contents of the invention
本发明的目的在于提供一种导管泵及折叠该导管泵的泵头的方法，实现从远端和近端均可收折导管泵的泵头。The object of the present invention is to provide a catheter pump and a method for folding the pump head of the catheter pump, so that the pump head of the catheter pump can be folded from both the distal end and the proximal end.
为达到上述目的，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:
本发明第一方面的导管泵包括导管、可转动地穿设在导管中的驱动轴、可折叠式泵头和导入器。可折叠式泵头包括连接至导管远端的泵壳、设在泵壳内的叶轮。叶轮连接至驱动轴的远端，驱动轴的近端可连接至马达，以将马达的旋转传递至叶轮。导入器包含适于将处于展开状态的泵头收容至其内的预收折通道，以使泵头切换至收折状态。导入器具有可滑动地套设在导管外的第一装配状态，以及，与导管泵分离设置的第二装配状态。The catheter pump of the first aspect of the present invention includes a catheter, a drive shaft rotatably inserted in the catheter, a foldable pump head and an introducer. The foldable pump head includes a pump casing connected to the distal end of the catheter and an impeller located in the pump casing. The impeller is connected to the distal end of the drive shaft, and the proximal end of the drive shaft is connectable to the motor to transmit rotation of the motor to the impeller. The introducer includes a pre-folded channel adapted to receive the pump head in the unfolded state, so that the pump head can be switched to the folded state. The introducer has a first assembly state in which it is slidably sleeved outside the catheter, and a second assembly state in which it is separated from the catheter pump.
当导入器处于第一装配状态时，通过向前推导入器和/或向后拉导管，使泵头经由导入器的远端收折进入预收折通道内。When the introducer is in the first assembled state, by pushing the introducer forward and/or pulling the catheter backward, the pump head is folded into the pre-folded channel through the distal end of the introducer.
当导入器处于第二装配状态时，泵头的远端可插入导入器的近端，通过向后拉导入器和/或向前推导管，使泵头经由导入器的近端收折进入预收折通道内；When the introducer is in the second assembly state, the distal end of the pump head can be inserted into the proximal end of the introducer, and by pulling the introducer backward and/or pushing the catheter forward, the pump head is folded into pre-retraction via the proximal end of the introducer. inside the folding channel;
所述导入器可在所述第一装配状态和所述第二装配状态中择一地使所述泵头收折进入所述预收折通道内。The introducer can selectively fold the pump head into the pre-folded channel in the first assembly state and the second assembly state.
折叠如上所述的导管泵的泵头的方法，包括：Methods for folding the pump head of a catheter pump as described above include:
当导入器处于第一装配状态时，操作导入器和导管中的至少一个，使导入器和泵头彼此的相互靠近运动，泵头的近端插入导入器的远端，并最终收折进入预收折通道。When the introducer is in the first assembly state, at least one of the introducer and the catheter is operated to move the introducer and the pump head closer to each other, and the proximal end of the pump head is inserted into the distal end of the introducer and finally folded into the pre-contraction fold channel.
当导入器处于第二装配状态时，操作导入器和泵头中的至少一个，使导入器和泵头彼此的相互靠近运动，泵头的远端插入导入器的近端内，并最终收折进入预收折通道。When the introducer is in the second assembly state, at least one of the introducer and the pump head is operated to move the introducer and the pump head closer to each other, and the distal end of the pump head is inserted into the proximal end of the introducer and finally folded Enter the pre-folding channel.
本发明第二方面的导管泵包括导管、可转动地穿设在导管中的驱动轴、可折叠式泵头、导入器和介入鞘。可折叠式泵头包括连接至导管远端的泵壳、设在泵壳内的叶轮。叶轮连接至驱动轴的远端，驱动轴的近端可连接至马达，以将马达的旋转传递至叶轮。介入鞘包含可接纳泵头的介入通道。导入器可操作地与介入鞘对接，包含适于将处于展开状态的泵头收容至其内的预收折通道。The catheter pump of the second aspect of the present invention includes a catheter, a driving shaft rotatably inserted in the catheter, a foldable pump head, an introducer and an interventional sheath. The foldable pump head includes a pump casing connected to the distal end of the catheter and an impeller located in the pump casing. The impeller is connected to the distal end of the drive shaft, and the proximal end of the drive shaft is connectable to the motor to transmit rotation of the motor to the impeller. The interventional sheath contains an interventional channel that can receive the pump head. The introducer is operably docked with the interventional sheath and includes a prefolded channel adapted to receive the pump head in a deployed state therein.
其中，导入器与导管泵分离设置，泵头的远端可与导入器的近端对接，并通过向后拉导入器和/或向前推导管，使泵头经由导入器的近端收折进入预收折通道内。Wherein, the introducer and the catheter pump are arranged separately, the distal end of the pump head can be docked with the proximal end of the introducer, and by pulling the introducer backward and/or pushing the catheter forward, the pump head can be folded through the proximal end of the introducer Enter the pre-folding channel.
导入器的远端与介入鞘的近端对接，通过向前推导管，使泵头由预收折通道转移至介入通道内。The distal end of the introducer is docked with the proximal end of the interventional sheath, and by pushing the catheter forward, the pump head is transferred from the pre-folded channel to the interventional channel.
折叠如上所述的导管泵的泵头的方法，包括：Methods for folding the pump head of a catheter pump as described above include:
操作导入器和泵头中的至少一个，使导入器和泵头彼此的相互靠近运动，泵头的远端插入导入器的近端内，并最终收折进入预收折通道。At least one of the introducer and the pump head is operated to move the introducer and the pump head closer to each other, the distal end of the pump head is inserted into the proximal end of the introducer, and is finally folded into the pre-folded channel.
将导入器的远端与介入鞘的近端对接，向前推送导管，使收折状态下的泵头由预收折通道转移至介入鞘内。Connect the distal end of the introducer to the proximal end of the interventional sheath, and push the catheter forward to transfer the folded pump head from the pre-folded channel into the interventional sheath.
导入器从近端和远端均可收折泵头，医生可依据操作习惯选择从近端或远端对泵头进行收折。并且，当从导入器的远端将泵头收折时，若误操作导致导入器从泵头远端滑脱，可从导入器的近端将泵头继续收折，操作简单。The introducer can fold the pump head from both the proximal and distal ends, and the doctor can choose to fold the pump head from the proximal or distal end according to operating habits. Moreover, when the pump head is folded from the distal end of the introducer, if misoperation causes the introducer to slip from the distal end of the pump head, the pump head can be further folded from the proximal end of the introducer, which is simple to operate.
附图说明Description of the drawings
图1是本发明提供的导管泵的立体示意图。Figure 1 is a schematic three-dimensional view of the catheter pump provided by the present invention.
图2是本发明提供的导管泵的另一立体示意图。Figure 2 is another perspective view of the catheter pump provided by the present invention.
图3是本发明提供的导入器处于可滑动地套设在导管外的第一装配状态的立体示意图。Figure 3 is a schematic perspective view of the introducer provided by the present invention in a first assembly state in which it is slidably sleeved outside the catheter.
图4是本发明提供的导入器处于和导管泵分离设置的第二装配状态的立体示意图。Figure 4 is a schematic perspective view of the introducer provided by the present invention in a second assembly state separated from the catheter pump.
图5是本发明提供的导管泵的部分结构剖面图。Figure 5 is a partial structural cross-sectional view of the catheter pump provided by the present invention.
图6是图5的局部放大图。FIG. 6 is a partial enlarged view of FIG. 5 .
图7是本发明另一实施例提供的导管泵的立体示意图。Figure 7 is a schematic three-dimensional view of a catheter pump provided by another embodiment of the present invention.
图8是本发明另一实施例提供的导管泵的另一立体示意图。Figure 8 is another three-dimensional schematic view of a catheter pump provided by another embodiment of the present invention.
图9是本发明另一实施例提供的导管泵的部分立体示意图。Figure 9 is a partial perspective view of a catheter pump provided by another embodiment of the present invention.
具体实施方式Detailed ways
本发明所用术语″近″、″后″和″远″、″前″是相对于操纵导管泵的医生而言的。术语″近″、″后″是指相对靠近医生的部分，术语″远″、″前″则是指相对远离医生的部分。例如，马达在近端及后端，保护头在远端及前端。As used herein, the terms "proximal", "posterior" and "distal", "anterior" are relative to the physician operating the catheter pump. The terms "near" and "posterior" refer to the part relatively close to the doctor, and the terms "distal" and "anterior" refer to the part relatively far away from the doctor. For example, the motor is at the proximal and rear ends, and the protective head is at the distal and front ends.
本发明的导管泵以驱动轴的延伸方向定义″轴向″或″轴向延伸方向″，术语″内″″外″是相对轴向延伸的中心线而言的，相对靠近中心线的方向为″内″，相对远离中心线的方向为″外″。The catheter pump of the present invention defines "axial" or "axial extension direction" in terms of the extension direction of the drive shaft. The terms "inner" and "outer" are relative to the axially extended centerline, and the direction relatively close to the centerline is "Inside", the direction relatively away from the center line is "outside".
需要理解的是，″近″、″远″、″后″、″前″、″内″、″外″、这些方位是为了方便描述而进行的定义。然而，导管泵可以在许多方向和位置使用，因此这些表达相对位置关系的术语并不是受限和绝对的。举例为，上述对各方向的定义，只是为了说明本发明技术方案的方便，并不限定本发明的导管泵在包括但不限定于产品测试、运输和制造等等其他可能导致其发生颠倒或者位置发生变换的场景中的方向。在本发明中，上述定义如果另有明确的规定和限定，它们应遵循上述明确的规定和限定。It should be understood that the directions of "near", "far", "back", "front", "inner" and "outer" are defined for convenience of description. However, catheter pumps can be used in many orientations and positions, so these terms expressing relative positional relationships are not restrictive and absolute. For example, the above definitions of various directions are only for the convenience of explaining the technical solution of the present invention, and do not limit the use of the catheter pump of the present invention in other situations including but not limited to product testing, transportation and manufacturing, etc. that may cause it to be inverted or positioned. The direction in the scene where the transformation occurs. In the present invention, if the above definitions have other explicit provisions and limitations, they shall follow the above explicit provisions and limitations.
请参见图1和图2，本发明实施例的导管泵100可至少部分地介入受试者内，以辅助心脏的泵血功能，减轻心脏负担。导管泵100可以作为左心室辅助，将左心室中的血液泵送至升主动脉中。也可作为右心室辅助，将静脉中的血液泵送至右心室。Referring to FIGS. 1 and 2 , the catheter pump 100 according to the embodiment of the present invention can be at least partially inserted into a subject to assist the pumping function of the heart and reduce the burden on the heart. The catheter pump 100 can act as a left ventricular assist, pumping blood from the left ventricle into the ascending aorta. It also acts as a right ventricular assist, pumping blood from the veins to the right ventricle.
下文将主要以导管泵100作为左心室辅助作为主述场景来阐述的。但基于上文描述可知，本发明实施例的保护范围并不因此而受到限定。The following description will mainly take the catheter pump 100 as a left ventricular assist as the main scenario. However, based on the above description, it can be seen that the protection scope of the embodiments of the present invention is not limited thereby.
导管泵100包括马达1、导管2、可通过导管2被输送至受试者心脏的期望位置例如左心室进行泵血的可折叠式泵头3、以及连接至导管2近端且用于与马达1可拆卸配合的耦合器4。可折叠式泵头3包括连接至导管2远端并具有进口端311和出口端312的泵壳31、及设在泵壳31内的叶轮(未示出)。The catheter pump 100 includes a motor 1, a catheter 2, a foldable pump head 3 that can be transported to a desired location of the subject's heart, such as the left ventricle, through the catheter 2 for pumping blood, and a foldable pump head 3 connected to the proximal end of the catheter 2 and used to communicate with the motor. 1Removable fitting coupler4. The foldable pump head 3 includes a pump housing 31 connected to the distal end of the catheter 2 and having an inlet end 311 and an outlet end 312, and an impeller (not shown) provided in the pump housing 31.
泵壳31包括由镍、钛合金制作的呈金属格构的支架313和覆盖在支架313上的弹性的覆膜314。覆膜314限定有血液流动通道，可以为弹性覆膜。支架313的金属格构具有网孔设计，覆膜314覆盖支架313的中部及后端部分，支架313前端未被覆膜314覆盖的部分的网孔形成进口端311。覆膜314的后端包覆在导管2远端外部，出口端312为形成在覆膜314后端的开口。The pump housing 31 includes a metal lattice bracket 313 made of nickel or titanium alloy and an elastic coating 314 covering the bracket 313 . The coating 314 defines a blood flow channel and may be an elastic coating. The metal lattice structure of the bracket 313 has a mesh design. The coating 314 covers the middle and rear end portions of the bracket 313 . The mesh of the front end of the bracket 313 that is not covered by the coating 314 forms the inlet end 311 . The rear end of the coating 314 is wrapped around the outside of the distal end of the catheter 2 , and the outlet end 312 is an opening formed at the rear end of the coating 314 .
叶轮包括轮毂及支撑在轮毂外壁的叶片。叶轮能被驱动旋转，以将血液从进口端311吸入泵壳31并从出口端312排出。The impeller includes a hub and blades supported on the outer wall of the hub. The impeller can be driven to rotate to draw blood into the pump housing 31 from the inlet end 311 and discharge it from the outlet end 312 .
导管泵100还包括可转动地穿设在导管2中的驱动轴(未示出)，驱动轴近端连接至马达1，远端连接至叶轮，以将马达1的旋转传递至叶轮，实现泵血。The catheter pump 100 also includes a drive shaft (not shown) rotatably installed in the catheter 2. The proximal end of the drive shaft is connected to the motor 1 and the distal end is connected to the impeller to transmit the rotation of the motor 1 to the impeller to realize the pump. Blood.
驱动轴包括可弯曲的软轴和连接至软轴远端的硬轴，软轴穿设在导管2中，硬轴穿设在轮毂中。The drive shaft includes a flexible flexible shaft and a hard shaft connected to the distal end of the flexible shaft. The flexible shaft is inserted into the catheter 2 and the hard shaft is inserted into the hub.
支架313的近端和远端分别连接近端轴承室(未示出)和远端轴承室32，近端轴承室和远端轴承室32中分别设有近端轴承和远端轴承(未示出)。硬轴的近端和远端分别穿设在近端轴承和远端轴承中。这样，硬轴两端被两个轴承支撑，再加上硬轴较高的刚性，可以使叶轮被较佳的保持在泵壳31内。The proximal end and the distal end of the bracket 313 are respectively connected to the proximal bearing chamber (not shown) and the distal bearing chamber 32. The proximal bearing chamber and the distal bearing chamber 32 are respectively provided with a proximal bearing and a distal bearing (not shown). out). The proximal end and the distal end of the hard shaft are respectively inserted into the proximal bearing and the distal bearing. In this way, both ends of the hard shaft are supported by two bearings, and coupled with the high rigidity of the hard shaft, the impeller can be better kept in the pump casing 31 .
马达1具有马达轴、及形成在马达壳前端用于与耦合器4配合的插接器。插接器包括与马达轴连接的主动磁体。耦合器4包括与驱动轴近端连接的被动磁体。通过插接器和耦合器4的拆卸，实现马达1与导管2的拆卸。The motor 1 has a motor shaft and a connector formed at the front end of the motor housing for mating with the coupler 4 . The connector includes an active magnet connected to the motor shaft. Coupler 4 includes a passive magnet connected to the proximal end of the drive shaft. By disassembling the connector and coupler 4, the motor 1 and the conduit 2 are disassembled.
泵头3和导管2前端部分被送入并保持在受试者体内，泵头3和导管2的尺寸尽可能的小是被期望的。较小尺寸的泵头3和导管2可以经由较小的穿刺口尺寸进入受试者身体内，减少介入过程给受试者带来的痛苦，并可以减小因穿刺口尺寸过大而导致的并发症。The pump head 3 and the front end portion of the catheter 2 are delivered and maintained in the subject's body, and it is desired that the size of the pump head 3 and the catheter 2 be as small as possible. The smaller size pump head 3 and catheter 2 can enter the subject's body through the smaller puncture port size, reducing the pain caused to the subject during the intervention process, and can reduce the risk of complications caused by the excessive size of the puncture port. complication.
本领域中，泵头3的尺寸和流体力学性能是两个相互矛盾的参数。出于减轻受试者的痛苦和介入容易的角度，希望泵头3的尺寸小。但是出于为受试者提供较强的辅助功能，希望泵头3的流量大，流量大一般要求泵头3的尺寸大。In this field, the size and hydrodynamic performance of the pump head 3 are two conflicting parameters. In order to reduce the pain of the subject and facilitate the intervention, it is desired that the size of the pump head 3 be small. However, in order to provide strong auxiliary functions for the subjects, it is hoped that the flow rate of the pump head 3 is large, and a large flow rate generally requires a large size of the pump head 3.
故此，为减小穿刺口尺寸，同时保证泵头3的流量大，泵头3为可收折式泵，具有收折状态和展开状态。具体的，在泵头3对应介入构型下，泵壳和叶轮处于收折状态，泵头3以较小的第一外径尺寸介入受试者脉管系统中和/或在受试者脉管系统中输送。在泵头3对应工作构型下，泵壳和叶轮处于展开状态，以便泵头3以大于第一径向尺寸的第二径向尺寸在期望位置泵送血液。Therefore, in order to reduce the size of the puncture port while ensuring a large flow rate of the pump head 3, the pump head 3 is a foldable pump with a folded state and an unfolded state. Specifically, in the corresponding intervention configuration of the pump head 3, the pump casing and impeller are in a folded state, and the pump head 3 is inserted into the subject's vasculature and/or in the subject's vasculature with a smaller first outer diameter. transported in the pipeline system. In the corresponding working configuration of the pump head 3, the pump casing and the impeller are in an expanded state, so that the pump head 3 pumps blood at a desired position with a second radial dimension that is larger than the first radial dimension.
通过设置可收折的泵头3，使得泵头3具有较小的收折尺寸和较大的展开尺寸，以兼顾在介入/输送过程中减轻受试者痛苦且介入容易，以及提供大流量这两方面的需求。By arranging the foldable pump head 3, the pump head 3 has a smaller folded size and a larger unfolded size, so as to reduce the pain of the subject during the intervention/delivery process, facilitate the intervention, and provide a large flow rate. Two needs.
由上述，泵壳31的多网孔尤其是菱形网孔的设计可实现较佳的实现收折，同时借助镍钛合金的记忆特性实现展开。叶轮的叶片由柔性材料制成或形状记忆材料制成，可相对轮毂发生弯折，具有收折构型和展开构型。处于收折构型下的叶片的叶尖靠近轮毂，处于展开构型下的叶片的叶尖远离轮毂。叶片在被收折时蓄能，在外界的约束撤除后，叶片的蓄能释放，使叶片展开。From the above, the multi-mesh design of the pump casing 31, especially the diamond-shaped mesh design, can achieve better folding and at the same time achieve unfolding with the help of the memory properties of nickel-titanium alloy. The blades of the impeller are made of flexible materials or shape memory materials, which can be bent relative to the hub and have a folded configuration and an unfolded configuration. The blade tips of the blades in the folded configuration are close to the hub, and the blade tips of the blades in the expanded configuration are away from the hub. The blades store energy when they are folded. After the external constraints are removed, the energy stored in the blades is released, allowing the blades to expand.
在泵头3对应介入构型时，叶片处于收折构型，其包裹在轮毂外壁上并至少部分地与泵壳31内壁接触。在泵头3对应工作构型时，叶片处于展开构型时，其自轮毂径向向外延伸并与泵头3的内壁间隔。When the pump head 3 is in the corresponding intervention configuration, the blades are in a folded configuration, wrapped around the outer wall of the hub and at least partially in contact with the inner wall of the pump housing 31 . When the pump head 3 corresponds to the working configuration, when the blades are in the deployed configuration, they extend radially outward from the hub and are spaced apart from the inner wall of the pump head 3 .
泵头3是借助外界的约束实现收折，在约束撤除后，泵头3实现自展开。在本实施例中，″收折状态″是指泵头3被径向约束的状态，也就是说，泵头3受到外界压力被径向压缩折叠成最小径向尺寸的状态。″展开状态″是指泵头3未被径向约束的状态，也就是说，支架313和叶轮径向外侧展开成最大径向尺寸的状态。The pump head 3 is folded with the help of external constraints. After the constraints are removed, the pump head 3 realizes self-expansion. In this embodiment, the "folded state" refers to the state in which the pump head 3 is radially constrained, that is to say, the pump head 3 is radially compressed and folded to the minimum radial size under external pressure. The "expanded state" refers to a state in which the pump head 3 is not radially constrained, that is, a state in which the bracket 313 and the impeller are expanded radially outward to the maximum radial size.
请参见图3至图5，导管泵100还包括导入器5，泵头3在展开状态和收折状态之间的切换，可通过导入器5实现。导入器5包含适于将处于展开状态的泵头3收容至其内的预收折通道51，以使泵头3切换至收折状态。Referring to FIGS. 3 to 5 , the catheter pump 100 further includes an introducer 5 , through which the pump head 3 can be switched between the unfolded state and the folded state. The introducer 5 includes a pre-folding channel 51 suitable for receiving the pump head 3 in the unfolded state, so that the pump head 3 can be switched to the folded state.
很显然，预收折通道51的内径尺寸限定泵头3处于收折状态的外径尺寸，也就是，预收折通道51的内径尺寸等于泵头3处于收折状态的外径尺寸。Obviously, the inner diameter of the pre-folded channel 51 limits the outer diameter of the pump head 3 in the folded state, that is, the inner diameter of the pre-folded channel 51 is equal to the outer diameter of the pump head 3 in the folded state.
导入器5具有可滑动地套设在导管2外的第一装配状态，以及，与导管泵100分离设置的第二装配状态。也就是，导入器5可作为导管泵100的部分结构，滑动设置在导管2外，或者，导入器5作为一个附件而单独存在，与导管泵100的任何部分都不存在装配关系。The introducer 5 has a first assembly state in which it is slidably sleeved outside the catheter 2 and a second assembly state in which it is separated from the catheter pump 100 . That is, the introducer 5 can be used as a part of the catheter pump 100 and is slidably disposed outside the catheter 2 . Alternatively, the introducer 5 can exist alone as an accessory and has no assembly relationship with any part of the catheter pump 100 .
导入器5被配置为可在第一装配状态和第二装配状态中择一地使泵头3收折进入预收折通道51内。泵头3可通过两个装配状态中的任意一个装配状态收折进入导入器5的预收折通道51内。在具体操作时可以按照期望的收折方式选择合适的装配状态，以便更好地操纵，而非限定同时采取两个装配状态。The introducer 5 is configured to fold the pump head 3 into the pre-folding channel 51 in either the first assembly state or the second assembly state. The pump head 3 can be folded into the pre-folded channel 51 of the introducer 5 through any one of the two assembly states. During specific operations, the appropriate assembly state can be selected according to the desired folding method for better manipulation, rather than being limited to two assembly states at the same time.
当导入器5处于第一装配状态时，通过向前推导入器5，或者向后拉导管2，或者向前推导入器5的同时向后拉导管2，使泵头3经由导入器5的远端收折进入预收折通道51内。When the introducer 5 is in the first assembly state, by pushing the introducer 5 forward, or pulling the catheter 2 backward, or pushing the introducer 5 forward while pulling the catheter 2 backward, the pump head 3 passes through the introducer 5 The far end is folded into the pre-folding channel 51.
当导入器5处于第二装配状态时，泵头3的远端可插入导入器5的近端，并通过向后拉导入器5、或者向前推导管2，或者向后拉导入器5的同时向前推导管2，使泵头3经由导入器5的近端收折进入预收折通道51内。When the introducer 5 is in the second assembly state, the distal end of the pump head 3 can be inserted into the proximal end of the introducer 5 by pulling the introducer 5 backward, pushing the catheter 2 forward, or pulling the introducer 5 backward. At the same time, the catheter 2 is pushed forward, so that the pump head 3 is folded into the pre-folded channel 51 through the proximal end of the introducer 5 .
施加在泵头3的外界约束，可通过导入器5完成。当导入器5处于第一装配状态时，导入器5向远端移动时，可将泵头3整体收纳在其内，实现泵头3的强制收折；然后导入器5向近端移动时，泵头3受到的径向约束消失，泵头3切换至展开状态。当导入器5处于第二装配状态时，导入器5向近端移动时，可将泵头3整体收纳在其内，实现泵头3的强制收折；然后导入器5向远端移动时，泵头3受到的径向约束消失，泵头3切换至展开状态。External constraints imposed on the pump head 3 can be accomplished through the introducer 5 . When the introducer 5 is in the first assembly state, when the introducer 5 moves to the distal end, the entire pump head 3 can be stored in it to achieve forced folding of the pump head 3; then when the introducer 5 moves to the proximal end, The radial constraint on the pump head 3 disappears, and the pump head 3 switches to the unfolded state. When the introducer 5 is in the second assembly state, when the introducer 5 moves toward the proximal end, the entire pump head 3 can be stored therein to realize forced folding of the pump head 3; then when the introducer 5 moves toward the distal end, The radial constraint on the pump head 3 disappears, and the pump head 3 switches to the unfolded state.
泵头3的收折，是借助导入器5施加的径向约束力实现的，而泵头3包含的叶轮收纳在泵壳31内。因此，实质上，泵头3的收折过程是：导入器5对泵壳31施加径向约束力，泵壳31径向压缩时，对叶轮施加径向约束力。The folding of the pump head 3 is achieved by means of the radial restraining force exerted by the introducer 5 , and the impeller contained in the pump head 3 is stored in the pump casing 31 . Therefore, in essence, the folding process of the pump head 3 is: the introducer 5 exerts a radial restraining force on the pump shell 31, and when the pump shell 31 is radially compressed, it exerts a radial restraining force on the impeller.
也就是，泵壳31是直接在导入器5的作用下被收折，而叶轮却是直接在泵壳31的作用下被收折。而如上述，叶轮具有弹性。因此，尽管处于收折状态，但叶轮收折蓄能使其始终具有径向展开的趋势，进而叶轮会与泵壳31内壁接触，并对泵壳31施加反作用力。That is, the pump casing 31 is folded directly under the action of the introducer 5 , while the impeller is folded directly under the action of the pump casing 31 . And as mentioned above, the impeller is elastic. Therefore, even though it is in a folded state, the folded impeller stores energy so that it always has a tendency to expand radially, and then the impeller will come into contact with the inner wall of the pump casing 31 and exert a reaction force on the pump casing 31 .
在导入器5的约束撤除后，泵壳31在自身的记忆特性作用下，支撑弹性的覆膜314展开，叶轮在释放的蓄能作用下自展开。After the constraints of the introducer 5 are removed, the pump casing 31 expands the elastic supporting film 314 under its own memory characteristics, and the impeller self-expands under the released stored energy.
导入器5可在第一装配状态和第二装配状态之间切换。导入器5可自第一装配状态切换至第二装配状态，或者，导入器5可自第二装配状态切换至第一装配状态。也就是，导入器5在第一装配状态时，通过向后拉导管2的方式将泵头3收折至导入器5内，当继续向后导管2时，会导致导入器5从泵头3远端滑脱，导入器5处于第二装配状态。通过将泵头3向前推送的方式将泵头3收折至导入器5内，当继续向前推送泵头3，则会导致导入器5套设在导管2外，导入器5处于第一装配状态。The introducer 5 is switchable between a first assembly state and a second assembly state. The introducer 5 can switch from the first assembly state to the second assembly state, or the introducer 5 can switch from the second assembly state to the first assembly state. That is, when the introducer 5 is in the first assembly state, the pump head 3 is folded into the introducer 5 by pulling the catheter 2 backward. The distal end slips off, and the introducer 5 is in the second assembly state. By pushing the pump head 3 forward, the pump head 3 is folded into the introducer 5. When the pump head 3 is continued to be pushed forward, the introducer 5 will be sleeved outside the catheter 2, and the introducer 5 will be in the first position. Assembly status.
由此，导入器5从近端和远端均可收折泵头3，从而方便医生操作，医生可依据自身操作习惯选择从近端或远端对泵头3进行收折。并且当使用第一装配状态对泵头3进行收折时，若误操作导致导入器5从泵头3远端滑脱，可利用第二装配状态继续对泵头3进行收折，操作简单。Therefore, the introducer 5 can fold the pump head 3 from both the proximal end and the distal end, thereby facilitating the doctor's operation. The doctor can choose to fold the pump head 3 from the proximal end or the distal end according to his own operating habits. And when the first assembly state is used to fold the pump head 3, if misoperation causes the introducer 5 to slip from the far end of the pump head 3, the second assembly state can be used to continue folding the pump head 3, which is simple to operate.
导入器5包括限定预收折通道51的导入器导管52、及设置在导入器导管52近端的导入器座54，该导入器座54限定一与预收折通道51连通的引导腔53。导入器导管52的内径尺寸限定泵头3处于收折状态的外径尺寸，从而打那个泵头3进入导入器导管52内，可实现泵头3的收折。The introducer 5 includes an introducer catheter 52 defining a pre-folded channel 51 and an introducer seat 54 disposed at the proximal end of the introducer catheter 52 . The introducer seat 54 defines a guide lumen 53 communicating with the pre-folded channel 51 . The inner diameter of the introducer conduit 52 defines the outer diameter of the pump head 3 in the folded state, so that the pump head 3 can be folded by entering the introducer conduit 52 .
请参见图6，引导腔53至少包含位于近端的膨大段531，膨大段531的内径至少不小于处于展开状态下的泵头3的直径。从而方便泵头3从导入器5的近端收折，且膨大段531起到导向作用，将泵头3导向至预收折通道51。避免预收折通道51的内径与泵头3处于展开状态的直径差距过大，而导致泵头3收折受阻，不顺畅且费力。Referring to FIG. 6 , the guide cavity 53 at least includes an enlarged section 531 located at the proximal end, and the inner diameter of the enlarged section 531 is at least not smaller than the diameter of the pump head 3 in the deployed state. This facilitates the folding of the pump head 3 from the proximal end of the introducer 5 , and the enlarged section 531 plays a guiding role to guide the pump head 3 to the pre-folding channel 51 . This prevents the gap between the inner diameter of the pre-folding channel 51 and the diameter of the pump head 3 in the unfolded state from being too large, causing the pump head 3 to be blocked from folding, making it unsmooth and laborious.
引导腔53还包括位于远端的颈缩段532，颈缩段532的内径小于膨大段531的内径且至少不大于预收折通道51的内径。颈缩段532以使收折状态下的泵头3顺畅的从颈缩段532转移至预收折通道51。The guide cavity 53 also includes a necked section 532 located at the distal end. The inner diameter of the necked section 532 is smaller than the inner diameter of the expanded section 531 and at least not larger than the inner diameter of the pre-folded channel 51 . The necking section 532 allows the pump head 3 in the folded state to smoothly transfer from the necking section 532 to the pre-folding channel 51 .
引导腔53还包括连接膨大段531与颈缩段532的过渡段533，过渡段533的内壁自近端向远端逐渐倾斜渐缩。当泵头3从膨大段531移动并经过过渡段533，因过渡段533逐渐减缩，内径尺寸逐渐减小，泵头3进行缓慢且逐渐收折，减小收折力，提高泵头3进入导入器5的平滑顺畅性。The guide cavity 53 also includes a transition section 533 connecting the enlarged section 531 and the constricted section 532. The inner wall of the transition section 533 is gradually inclined and tapered from the proximal end to the distal end. When the pump head 3 moves from the expansion section 531 and passes through the transition section 533, because the transition section 533 gradually shrinks, the inner diameter gradually decreases. The pump head 3 folds slowly and gradually, reducing the folding force and increasing the entrance of the pump head 3. The smoothness of the device 5.
请参见图5和图6，导入器座54构造成操作把手54，引导腔53形成在操作把手54上。操作把手54设置在导入器导管52的近端，方便医生通过握持操作把手54进行向前端或后端的移动，提高其可操作性。Referring to FIGS. 5 and 6 , the introducer seat 54 is configured as an operating handle 54 and a guide cavity 53 is formed on the operating handle 54 . The operating handle 54 is provided at the proximal end of the introducer catheter 52, which facilitates the doctor to move the front end or the rear end by holding the operating handle 54, thereby improving its operability.
导入器导管52的材质为PTFE。采用摩擦系数低的PTFE材质，可有效降低泵头3在导入器导管52内相对移动时的输送力，提高输送的顺应性。在其他实施例中，导入器导管52的材质还可为其他摩擦系数低的材料，在此不一一列举。The material of the introducer tube 52 is PTFE. The use of PTFE material with low friction coefficient can effectively reduce the delivery force when the pump head 3 moves relatively within the introducer conduit 52 and improve the compliance of delivery. In other embodiments, the material of the introducer conduit 52 can also be other materials with low friction coefficients, which are not listed here.
导管泵100包括连接至泵头3远端的保护头6，为了导入器5能够顺利地从远端收折泵头3，保护头6沿泵头3轴线延伸，也就是保护头6呈直线状，从而能够顺利地从远端进入至导入器5内。另外，保护头6被配置为是柔软的，从而不伤害受试者的组织，保护头6可以由任意的宏观表现出柔性的材料制成，该柔性的端部以无创或无损伤的方式支撑在心室内壁上，将泵头3的吸入口与心室内壁隔开，避免泵头3在工作过程中由于流体(血液)的反作用力而使泵头3的吸入口贴合在心室内壁上，保证泵吸的有效面积。The catheter pump 100 includes a protective head 6 connected to the distal end of the pump head 3. In order for the introducer 5 to smoothly fold the pump head 3 from the distal end, the protective head 6 extends along the axis of the pump head 3, that is, the protective head 6 is linear. , so that it can enter the introducer 5 from the remote end smoothly. In addition, the protective head 6 is configured to be soft, so as not to harm the tissue of the subject. The protective head 6 can be made of any macroscopically flexible material, and the flexible end is supported in a non-invasive or non-damaging manner. On the inner wall of the ventricle, separate the suction port of the pump head 3 from the inner wall of the ventricle to prevent the suction port of the pump head 3 from being attached to the inner wall of the ventricle due to the reaction force of the fluid (blood) during the working process, ensuring that Effective area for pumping.
本发明还提供一种折叠(收折)如上所示的导管泵的泵头的方法，其包括：The present invention also provides a method for folding (folding) the pump head of the catheter pump as shown above, which includes:
当导入器处于第一装配状态时，操作导入器和导管中的至少一个，使导入器和泵头彼此的相互靠近运动，泵头的近端插入导入器的远端，并最终收折进入预收折通道；When the introducer is in the first assembly state, at least one of the introducer and the catheter is operated to move the introducer and the pump head closer to each other, and the proximal end of the pump head is inserted into the distal end of the introducer and finally folded into the pre-contraction fold channel;
当导入器处于第二装配状态时，操作导入器和泵头中的至少一个，使导入器和泵头彼此的相互靠近运动，泵头的远端插入导入器的近端内，并最终收折进入预收折通道。When the introducer is in the second assembly state, at least one of the introducer and the pump head is operated to move the introducer and the pump head closer to each other, and the distal end of the pump head is inserted into the proximal end of the introducer and finally folded Enter the pre-folding channel.
将泵头折叠(收折)后以方便后续输送至受试者的脉管系统。The pump head is folded (folded) to facilitate subsequent delivery to the subject's vasculature.
其中，当导入器处于第一装配状态时，操作导入器和泵头中的至少一个，使导入器和泵头彼此的相互靠近运动的方法为：通过向前推导入器，或者向后拉导管，或者向前推导入器的同时向后拉导管，从而使泵头经由导入器的远端收折进入预收折通道内，以使泵头切换至收折状态。Wherein, when the introducer is in the first assembly state, the method of operating at least one of the introducer and the pump head to move the introducer and the pump head closer to each other is by pushing the introducer forward or pulling the catheter backward. , or push the introducer forward while pulling the catheter backward, so that the pump head is folded into the pre-folded channel through the distal end of the introducer, so that the pump head is switched to the folded state.
当导入器处于第二装配状态时，操作导入器和泵头中的至少一个，使导入器和泵头彼此的相互靠近运动的方法为：泵头的远端可与导入器的近端对接，并通过向后拉导入器，或者向前推导管，或者向后拉导入器的同时向前推导管，从而使泵头经由导入器的近端收折进入预收折通道内，以使泵头切换至收折状态。When the introducer is in the second assembly state, the method of operating at least one of the introducer and the pump head to move the introducer and the pump head closer to each other is: the distal end of the pump head can be docked with the proximal end of the introducer, And by pulling the introducer backward, or pushing the catheter forward, or pulling the introducer backward and pushing the catheter forward at the same time, the pump head is folded into the pre-folded channel through the proximal end of the introducer to switch the pump head. to the folded state.
请参见图7至图9，本发明另一实施例提供的导管泵200，与上述实施例提供的导管泵100基本相同，不同点为本实施例的导管泵200还包括介入鞘7，该介入鞘7包含可接纳泵头3的介入通道。导入器5可操作地与介入鞘7对接，以使得介入通道和预收折通道连通。Please refer to FIGS. 7 to 9 . A catheter pump 200 provided by another embodiment of the present invention is basically the same as the catheter pump 100 provided by the above embodiment. The difference is that the catheter pump 200 of this embodiment also includes an interventional sheath 7 . The sheath 7 contains an access channel that can receive the pump head 3 . The introducer 5 is operably docked with the interventional sheath 7 so that the interventional channel and the pre-folded channel are connected.
其中，导入器5与导管泵200分离设置，泵头3的远端可与导入器5的近端对接，并通过向后拉导入器5，或者向前推导管2，或者向后拉导入器5的同事向前推导管2，使泵头3经由导入器5的近端收折进入预收折通道内。关于导入器5收折泵头3呈上述，在此不再赘述。The introducer 5 is separated from the catheter pump 200. The distal end of the pump head 3 can be docked with the proximal end of the introducer 5, and the introducer 5 can be pulled backward, the catheter 2 can be pushed forward, or the introducer can be pulled backward. 5's colleagues push the catheter 2 forward so that the pump head 3 is folded through the proximal end of the introducer 5 and enters the pre-folded channel. The folding of the pump head 3 by the introducer 5 is as described above and will not be repeated here.
导入器5的远端与介入鞘7的近端对接，通过向前推导管2，使泵头3由预收折通道转移至介入通道内。The distal end of the introducer 5 is docked with the proximal end of the interventional sheath 7, and by pushing the catheter 2 forward, the pump head 3 is transferred from the pre-folded channel to the interventional channel.
其中，导入器5可操作地与介入鞘7对接的方式可为导入器5至少部分可操作地穿入介入鞘7中，以实现预收折通道和介入通道连通，具体的如图9所示。The introducer 5 can be operatively docked with the interventional sheath 7 by at least partially operably penetrating the introducer 5 into the interventional sheath 7 to achieve communication between the pre-folded channel and the interventional channel, as shown in Figure 9 .
导入器5可操作地与介入鞘7对接的另一种方式为导入器5的远端和介入鞘7的近端进行端面对接，以实现预收折通道和介入通道连通，具体的如图7和图8所示。Another way for the introducer 5 to be operatively docked with the interventional sheath 7 is for end-to-end connection between the distal end of the introducer 5 and the proximal end of the interventional sheath 7 to achieve communication between the pre-folded channel and the interventional channel, as shown in Figures 7 and 7 As shown in Figure 8.
泵头3以收折状态穿过介入鞘7被输送至脉管系统，实现泵头3以较小的介入尺寸进入受试者体内。The pump head 3 is transported to the vasculature system through the interventional sheath 7 in a folded state, allowing the pump head 3 to enter the subject's body with a smaller intervention size.
介入鞘7的内径小于耦合器4的外径，可通过穿刺口部分地介入受试者的脉管系统。介入鞘7前端通过穿刺口进入脉管系统，后端留在人体外，用于形成或建立设备进入脉管系统的通路。The inner diameter of the interventional sheath 7 is smaller than the outer diameter of the coupler 4 and can partially intervene into the subject's vasculature through the puncture port. The front end of the interventional sheath 7 enters the vasculature through the puncture port, and the rear end remains outside the body to form or establish a passage for the device to enter the vasculature.
为了套设在泵头3和导管2上，导入器5的内径大于导管2外径和处于收折状态下的泵头3的外径。In order to be sleeved on the pump head 3 and the catheter 2, the inner diameter of the introducer 5 is larger than the outer diameter of the catheter 2 and the outer diameter of the pump head 3 in the folded state.
为了实现导入器5和介入鞘7对接，导入器5的内径小于或等于介入鞘7的内径。在一实施例中，导入器5的外径可小于或等于介入鞘7的内径，以实现导入器5至少部分可操作地穿入介入鞘7中。In order to achieve docking between the introducer 5 and the interventional sheath 7 , the inner diameter of the introducer 5 is smaller than or equal to the inner diameter of the interventional sheath 7 . In one embodiment, the outer diameter of the introducer 5 may be smaller than or equal to the inner diameter of the interventional sheath 7 , so that the introducer 5 can be at least partially operably penetrated into the interventional sheath 7 .
在导管泵100介入受试者体内辅助泵血时，导管泵100保持介入受试者在体内的状态，介入鞘7保持在穿刺口中。When the catheter pump 100 is inserted into the subject's body to assist in pumping blood, the catheter pump 100 maintains the state of the inserted subject in the body, and the interventional sheath 7 remains in the puncture port.
当导入器5为长鞘时，由于其自身长度，且长鞘的内径尺寸小于耦合器4的外径尺寸，耦合器4无法穿入长鞘内，可能会导致长鞘与耦合器4发生干涉而限制泵头3在受试者的脉管系统的移动。为此，长鞘为可撕鞘，可撕鞘在泵头3进入脉管系统中后被可操作地剥离，介入鞘7穿设在穿刺口中，从而避免了可撕鞘对耦合器4的干涉。When the introducer 5 is a long sheath, due to its own length and the inner diameter of the long sheath being smaller than the outer diameter of the coupler 4, the coupler 4 cannot penetrate into the long sheath, which may cause interference between the long sheath and the coupler 4. And restrict the movement of the pump head 3 in the subject's vasculature. For this reason, the long sheath is a tearable sheath. The tearable sheath is operably peeled off after the pump head 3 enters the vasculature. The interventional sheath 7 is inserted into the puncture port, thus avoiding the interference of the tearable sheath on the coupler 4. .
可撕鞘可操作地剥离的方法为：可撕鞘向近端移动的同时，撕开可撕鞘。The method for operable peeling of the tearable sheath is to tear the tearable sheath while moving the tearable sheath proximally.
因可撕鞘的内径尺寸小于耦合器4的外径尺寸，可撕鞘在被剥离过程中形成的近端两个部分不与耦合器4相干涉，从而可撕鞘能够顺利撤出穿刺口。Since the inner diameter of the tearable sheath is smaller than the outer diameter of the coupler 4, the two proximal parts formed during the peeling process of the tearable sheath do not interfere with the coupler 4, so that the tearable sheath can be smoothly withdrawn from the puncture port.
为了实现可撕鞘被轻松剥离，而不受耦合器4的影响，可撕鞘在近端可具有侧向开口(未示出)，可沿该侧向开口将可撕鞘剥开，操作省力方便。In order to realize that the tearable sheath can be peeled off easily without being affected by the coupler 4, the tearable sheath can have a lateral opening (not shown) at the proximal end, and the tearable sheath can be peeled off along the lateral opening, so that the operation is labor-saving. convenient.
侧向开口可设置有两个，两个侧向开口相对设置在可撕鞘近端的两侧。Two lateral openings may be provided, and the two lateral openings are provided oppositely on both sides of the proximal end of the tearable sheath.
在另一实施方式中，可撕鞘可在对称位置两侧各连接一条预压撕开缝。将可撕鞘剥离时，可一边向近端撤离一边沿着预压撕开缝将可撕鞘撕开成两半。In another embodiment, the tearable sheath can be connected with a pre-pressed tearing slit on both sides of the symmetrical position. When peeling off the tearable sheath, you can tear the tearable sheath into two halves along the pre-pressure tearing seam while withdrawing toward the proximal end.
可撕鞘可采用聚四氟乙烯材质，通过冲压工艺一体成型制造成两半对称完全一致的可撕鞘管，将两半对称完全一致的可撕鞘管通过热熔工艺对接，在对接处形成预压撕开缝。The tearable sheath can be made of polytetrafluoroethylene and is integrally formed through a stamping process to form two halves of a symmetrical and completely consistent tearable sheath tube. The two halves of the symmetrical and completely consistent tearable sheath tube are butted through a hot melt process to form a tearable sheath tube at the joint. Pre-pressed tear seams.
请参见图7和图8，介入鞘7的近端设有第一锁扣71，导入器5的远端设有第二锁扣55，第一锁扣71和第二锁扣22可拆卸的锁合。Please refer to Figures 7 and 8. The proximal end of the interventional sheath 7 is provided with a first lock 71, and the distal end of the introducer 5 is provided with a second lock 55. The first lock 71 and the second lock 22 are detachable. Lock.
当导入器5的远端和介入鞘7的对接时，通过向前推导管2，使泵头3由预收折通道转移至介入通道内。此时，第一锁扣71和第二锁扣22锁合，导入器5和介入鞘7之间无法相对分离。从而防止向前推导管2时，由于泵头3的反作用力，使导入器5向后移动而与介入鞘7分离而导致泵头3从预收折通道转移至介入通道的过程受阻，也避免泵头3转移过程中导致介入鞘7在外力作用下在穿刺口移动而破坏穿刺口。保证穿刺口的尺寸，有利于穿刺口愈合且降低穿刺口并发症概率，同时可减轻受试者痛苦。When the distal end of the introducer 5 and the interventional sheath 7 are docked, the pump head 3 is transferred from the pre-folded channel to the interventional channel by pushing the catheter 2 forward. At this time, the first lock 71 and the second lock 22 are locked, and the introducer 5 and the interventional sheath 7 cannot be relatively separated. This prevents the introduction device 5 from moving backward and separating from the interventional sheath 7 due to the reaction force of the pump head 3 when the catheter 2 is pushed forward, causing the pump head 3 to be blocked from being transferred from the pre-folded channel to the interventional channel, and also prevents the pump from being blocked. During the transfer process of the head 3, the interventional sheath 7 moves in the puncture port under the action of external force and damages the puncture port. Ensuring the size of the puncture port is beneficial to the healing of the puncture port and reduces the probability of puncture port complications, while also reducing the pain of the subject.
关于第一锁扣71和第二锁扣22的结构在此不做具体限定，为可拆卸地锁合即可。The structures of the first lock 71 and the second lock 22 are not specifically limited here, as long as they can be detachably locked.
本发明还提供一种折叠如上所示的导管泵的泵头的方法，包括：The present invention also provides a method for folding the pump head of the catheter pump as shown above, including:
操作导入器和泵头中的至少一个，使导入器和泵头彼此的相互靠近运动，泵头的远端插入导入器的近端内，并最终收折进入预收折通道；Operating at least one of the introducer and the pump head to move the introducer and the pump head closer to each other, insert the distal end of the pump head into the proximal end of the introducer, and finally fold it into the pre-folded channel;
将导入器的远端与介入鞘的近端对接，向前推送导管，使收折状态下的泵头由预收折通道转移至介入鞘内。Connect the distal end of the introducer to the proximal end of the interventional sheath, and push the catheter forward to transfer the folded pump head from the pre-folded channel into the interventional sheath.
关于将泵头收折进入预收折通道呈上述，在此不再赘述。The folding of the pump head into the pre-folding channel is as described above and will not be repeated here.
泵头由预收折通道转移至介入通道内的过程中，导入器与介入鞘轴向保持固定，具体的，通过第一锁扣和第二锁扣的锁合实现。When the pump head is transferred from the pre-folded channel to the interventional channel, the introducer and the interventional sheath are kept axially fixed. Specifically, this is achieved through the locking of the first lock and the second lock.
其中，介入鞘通过穿刺口被部分地介入受试者的脉管系统，在泵头转移至介入鞘内后，方法还包括：继续向前推送导管，使泵头从介入鞘的远端移出，以展开状态进入受试者的脉管系统，并介入至目标位置，将马达和导管配合连接，可实现导管泵的泵血工作状态。Wherein, the interventional sheath is partially inserted into the subject's vasculature through the puncture port. After the pump head is transferred into the interventional sheath, the method further includes: continuing to push the catheter forward to remove the pump head from the distal end of the interventional sheath, It enters the subject's vasculature in an expanded state and intervenes to the target location. The motor and catheter are connected to achieve the blood pumping working state of the catheter pump.
需要说明的是，介入鞘始终有部分穿设在穿刺口中，以方便后续泵头从受试者体内移出操作。It should be noted that the interventional sheath is always partially inserted into the puncture port to facilitate the subsequent removal of the pump head from the subject's body.
当导管泵辅助泵血完成后，将导管泵从受试者移出的操作为：向近端拉动导管，将处于展开状态的泵收容至介入鞘内，以使泵头切换至收折状态；继续向近端拉动导管，使泵头从介入鞘内移出。最后将介入鞘向近端拉动从体内移出即可。After the catheter pump assists in pumping blood, the operation of removing the catheter pump from the subject is as follows: pulling the catheter toward the proximal end, and receiving the pump in the unfolded state into the interventional sheath to switch the pump head to the folded state; continue Pull the catheter proximally to remove the pump head from the interventional sheath. Finally, pull the interventional sheath proximally and remove it from the body.
本发明的导入器可滑动地套设在导管外，或者与导管泵分离设置。当导入器可滑动地套设在导管外时，可从导入器的远端将泵头收折。当导入器和导管泵分离设置时，可从导入器的近端将泵头收折。导入器从近端和远端均可收折泵头，从而方便医生操作，医生可依据自身操作习惯选择从近端或远端对泵头进行收折。并且当从导入器的远端将泵头收折时，若误操作导致导入器从泵头远端滑脱，可从导入器的近端将泵头继续收折，操作简单。The introducer of the present invention is slidably sleeved outside the catheter, or is provided separately from the catheter pump. When the introducer is slidably sleeved outside the catheter, the pump head can be folded from the distal end of the introducer. When the introducer and catheter pump are installed separately, the pump head can be folded from the proximal end of the introducer. The introducer can fold the pump head from both the proximal and distal ends, making it easier for doctors to operate. Doctors can choose to fold the pump head from the proximal or distal end according to their own operating habits. And when the pump head is folded from the distal end of the introducer, if misoperation causes the introducer to slip from the distal end of the pump head, the pump head can be further folded from the proximal end of the introducer, which is simple to operate.
以上实施例仅表达了本发明的几种实施方式，其描述较为具体和详细，但并不能因此而理解为对发明专利范围的限制。应当指出的是，对于本领域的普通技术人员来说，在不脱离本发明构思的前提下，还可以做出若干变形和改进，这些都属于本发明的保护范围。因此，本发明专利的保护范围应以所附权利要求为准。The above embodiments only express several embodiments of the present invention, and their descriptions are relatively specific and detailed, but they should not be construed as limiting the scope of the invention. It should be noted that, for those of ordinary skill in the art, several modifications and improvements can be made without departing from the concept of the present invention, and these all belong to the protection scope of the present invention. Therefore, the scope of protection of the patent of the present invention should be determined by the appended claims.
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2022102528261 | 2022-03-15 | ||
| CN202210252826 | 2022-03-15 |
| Publication Number | Publication Date |
|---|---|
| CN116785584Atrue CN116785584A (en) | 2023-09-22 |
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202211331813.XAPendingCN116785584A (en) | 2022-03-15 | 2022-10-28 | Catheter pump and method for folding pump head of catheter pump |
| Country | Link |
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| CN (1) | CN116785584A (en) |
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| CN108601872A (en)* | 2016-02-11 | 2018-09-28 | 阿比奥梅德欧洲股份有限公司 | blood pump |
| US20200345337A1 (en)* | 2019-05-01 | 2020-11-05 | Tc1 Llc | Introducer sheath assembly for catheter systems and methods of using same |
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