技术领域technical field
本发明属于瓣膜置入技术领域，涉及一种瓣膜释放装置，尤其涉及一种瓣膜释放组件及输送瓣膜的装置。The invention belongs to the technical field of valve implantation, and relates to a valve releasing device, in particular to a valve releasing component and a device for delivering a valve.
背景技术Background technique
随着经导管瓣膜置换技术（TAVI和TMVI）日渐成熟，介入人工心脏瓣膜（以下简称“介入瓣”）临床应用也日益增多。如何以最小的损伤将介入瓣送达且精准释放在目标位置，需要一个操作简便，控制精准的瓣膜输送系统。With the maturity of transcatheter valve replacement technology (TAVI and TMVI), the clinical application of interventional artificial heart valves (hereinafter referred to as "interventional valves") is also increasing. How to deliver and accurately release the interventional valve at the target position with minimal damage requires an easy-to-operate and precisely controlled valve delivery system.
目前介入瓣根据其释放机制主要分为两类，球囊扩张式和自膨胀式。无论是哪类介入瓣，都需要预装载在相应的输送系统的导管内，经导管进入体内并被送至目标位置后，分步撤除束缚部件，介入瓣随即释放展开并固定在目标位置。然而有时在将介入瓣送至目标位置后，由于输送系统控制力不够精准，导致释放速度过快，瓣膜展开固定后发现瓣膜固定位置不够理想，却无法再次调整。因此，需要输送系统具备在瓣膜全部或部分释放但尚未与系统解脱时，可以回收进导管，将其调整至理想位置后，再次进行释放的功能，这样可以确保瓣膜能够固定在最佳位置，然而现有产品输送系统在这方面的功能仍有欠缺。At present, interventional valves are mainly divided into two types according to their release mechanism, balloon-expandable and self-expandable. Regardless of the type of interventional valve, it needs to be pre-loaded in the catheter of the corresponding delivery system. After entering the body through the catheter and being delivered to the target position, the restraining parts are removed step by step, and the interventional valve is released and deployed and fixed at the target position. However, sometimes after the interventional valve is delivered to the target position, the release speed is too fast due to the inaccurate control of the delivery system. After the valve is deployed and fixed, it is found that the fixed position of the valve is not ideal, but it cannot be adjusted again. Therefore, it is necessary for the delivery system to have the function of recovering the catheter when the valve is fully or partially released but has not yet been released from the system, and adjusting it to the ideal position before releasing it again, so as to ensure that the valve can be fixed in the optimal position. Existing product delivery systems are still lacking in this regard.
CN1961847A公开了一种人工心脏瓣膜及其输放装置，包括管型网状支架、连接在网状支架中段的瓣膜叶、覆盖在网状支架上的密封膜以及设置在网状支架上的不透X线标志和柔性联结环。输放装置包括导管头、内管、近端控制器、中管、导丝管、外保护机构、至少一根锁定丝和至少一根支架拉线。该输放装置可以用于人工心脏瓣膜的输放，但无法做到瓣膜的回收，也无法控制瓣膜的释放速度。CN1961847A discloses an artificial heart valve and its delivery device, comprising a tubular mesh support, valve leaflets connected to the middle section of the mesh support, a sealing membrane covering the mesh support, and an impermeable valve arranged on the mesh support. X-ray markers and flexible coupling ring. The delivery device includes a catheter head, an inner tube, a near-end controller, a middle tube, a guide wire tube, an outer protection mechanism, at least one locking wire and at least one support pull wire. The delivery device can be used for the delivery of the artificial heart valve, but it cannot recover the valve, nor can it control the release speed of the valve.
CN114081696A公开了一种血管支架释放装置，包括脚架、内管、中管以及外管。脚架具有中心段、连接在中心段一端的推动段和连接在中心段另一端的回收段，推动段具有朝向远端方向沿径向向外弹性伸出的推动卡爪，回收段具有朝向近端方向沿径向向外弹性伸出的回收卡爪；内管与脚架的中心段固定连接；中管套设在内管及脚架的外部，中管的远端具有适于脚架的推动段伸出的第一开口，中管的远端的侧壁具有适于脚架的回收段伸出的第二开口；外管套设在中管外，外管与中管之间适用于容纳支架。CN114081696A discloses a vascular stent releasing device, which includes a tripod, an inner tube, a middle tube and an outer tube. The tripod has a center section, a push section connected to one end of the center section and a recovery section connected to the other end of the center section. The recovery jaw elastically protrudes radially outward in the end direction; the inner tube is fixedly connected with the central section of the tripod; the middle tube is sleeved outside the inner tube and the tripod, and the distal end of the middle tube has a The first opening protruding from the pushing section, the side wall at the far end of the middle tube has a second opening suitable for the stretching out of the recovery section of the tripod; the outer tube is sleeved outside the middle tube, and the space between the outer tube and the middle tube is suitable for Holds the stand.
该装置能够进行血管支架的释放与回收，但无法实现血管支架的准确释放，也无法控制血管支架的释放速度。The device is capable of releasing and recovering the vascular stent, but cannot realize accurate release of the vascular stent, nor can it control the release speed of the vascular stent.
CN115300187A公开了一种稳定释放和回收的瓣膜输送系统，包括植入器械、输送导管、释放装置与约束装置，约束装置能相对于释放装置远离移动和受限制地靠近移动，释放装置与输送导管连接；植入器械预装时，植入器械与约束装置可拆卸连接，且植入器械的远端部与约束装置限制在释放装置内；在释放植入器械的过程中，约束装置相对于释放装置进行了远离移动，同时，在回收释放装置器件，为防止植入器械牵扯或钩住释放装置，在释放装置穿过植入器械过程中，第二约束件对第一约束件提供了作用力以保证第一约束件静止或小幅度运动，使第一约束件与释放装置的近端保持接触或相邻近。该瓣膜输送系统能够利用弹簧实现瓣膜的释放与回收，到受限于弹性件的结构，其对瓣膜释放的控制有待进一步提高。CN115300187A discloses a valve delivery system for stable release and recovery, including implantation equipment, a delivery catheter, a release device and a restraint device, the restraint device can move away from the release device and move close to it in a restricted manner, and the release device is connected to the delivery catheter ; When the implant device is pre-installed, the implant device and the restraint device are detachably connected, and the distal end of the implant device and the restraint device are restricted in the release device; during the process of releasing the implant device, the restraint device is relative to the release device At the same time, when the release device is retracted, in order to prevent the implant device from pulling or hooking the release device, the second restraint provides a force to the first restraint during the release device passing through the implant device. Ensure that the first restraining member is stationary or moves in a small range, so that the first restraining member remains in contact with or adjacent to the proximal end of the release device. The valve delivery system can use the spring to realize the release and recovery of the valve, but it is limited by the structure of the elastic member, and its control over the release of the valve needs to be further improved.
发明内容Contents of the invention
针对现有技术存在的不足，本发明的目的在于提供一种瓣膜释放组件及输送瓣膜的装置；所述瓣膜释放组件能够实现瓣膜释放速度的控制，达到精准释放的目的；所述输送瓣膜的装置能够实现瓣膜的释放与全释放后的回收，且释放过程中能够控制瓣膜的释放速度，避免瓣膜在释放时出现跑飞的现象，从而实现瓣膜的精准释放与回收。Aiming at the deficiencies in the prior art, the object of the present invention is to provide a valve release assembly and a valve delivery device; the valve release assembly can control the release speed of the valve to achieve the purpose of precise release; the valve delivery device The valve can be released and recovered after full release, and the release speed of the valve can be controlled during the release process to avoid the phenomenon of the valve running away during release, so as to realize the precise release and recovery of the valve.
为达此目的，本发明采用以下技术方案：For reaching this purpose, the present invention adopts following technical scheme:
第一方面，本发明提供了一种瓣膜释放组件，所述瓣膜释放组件包括连接部、锁件、控制部与卡槽连接件；In the first aspect, the present invention provides a valve release assembly, which includes a connecting part, a lock, a control part, and a slot connector;
所述连接部包括固定件；所述固定件的一端设置连接件，另一端与锁件连接；The connecting part includes a fixing piece; one end of the fixing piece is provided with a connecting piece, and the other end is connected with the lock piece;
所述控制部包括基座；所述基座的一端设置控制件，另一端与卡槽连接件连接；The control part includes a base; one end of the base is provided with a control part, and the other end is connected with the slot connector;
所述锁件设置有与控制件对应的通孔；所述控制件穿设于锁件的对应通孔，分布于连接件的内侧。The lock piece is provided with a through hole corresponding to the control piece; the control piece passes through the corresponding through hole of the lock piece and is distributed inside the connecting piece.
本发明中的“远端”是指远离操作者的一端，本发明中的“近端”是指靠近操作者的一端。相对应的，“远端”是指靠近患者的一端，“近端”是指远离患者的一端。The "distal end" in the present invention refers to the end away from the operator, and the "proximal end" in the present invention refers to the end close to the operator. Correspondingly, "distal end" refers to the end close to the patient, and "proximal end" refers to the end away from the patient.
应用本发明所述瓣膜释放组件时，瓣膜的支腿沿径向方向依次由外侧向内侧穿过连接件与控制件，当需要释放瓣膜时，使控制部相对于连接部向近端移动，从而使支腿首先与控制件分离。本领域所用瓣膜的材料为具有记忆金属特性的镍钛材料，在自膨力的作用下支腿进一步与连接部分离，从而实现了瓣膜的分步释放。When using the valve release assembly of the present invention, the legs of the valve pass through the connecting part and the control part sequentially from the outside to the inside in the radial direction, and when the valve needs to be released, the control part moves proximally relative to the connecting part, thereby Separate the outriggers from the controls first. The material of the valve used in this field is a nickel-titanium material with memory metal properties, and the legs are further separated from the connecting part under the action of self-expansion force, thereby realizing the step-by-step release of the valve.
本发明提供的瓣膜释放组件结构简单，能够实现瓣膜的分步释放，从而解决了瓣膜在释放时的跑飞问题，使瓣膜释放更为准确。The valve release assembly provided by the invention has a simple structure and can realize the step-by-step release of the valve, thereby solving the problem of the valve running away during release and making the valve release more accurate.
优选地，所述固定件设置连接件的相对端设置有第一卡接件；所述第一卡接件与锁件卡接。Preferably, the opposite end of the connecting part for setting the fixing part is provided with a first clamping part; the first clamping part is engaged with the locking part.
本发明所述第一卡接件的形状为任意能够实现与锁件卡接的形状，锁件外壁设置有与第一卡接件形状对应的限位槽；示例性的，本发明所述第一卡接件包括但不限于T型头。The shape of the first clamping piece in the present invention is any shape that can be clamped with the lock piece, and the outer wall of the lock piece is provided with a limit groove corresponding to the shape of the first clamping piece; exemplary, the first clamping piece in the present invention A clip includes but is not limited to a T-head.
优选地，所述基座设置控制件的相对端设置有第二卡接件；所述第二卡接件与卡槽连接件卡接。Preferably, the opposite end of the base setting control part is provided with a second clamping part; the second clamping part is clamped with the slot connection part.
本发明所述第二卡接件的形状为任意能够实现与卡槽连接件卡接的形状，卡槽连接件的外壁设置有与第二卡接件形状对应的限位槽；示例性的，本发明所述第二卡接件包括但不限于T型头。The shape of the second clamping part in the present invention is any shape capable of being clamped with the slot connector, and the outer wall of the slot connector is provided with a limiting groove corresponding to the shape of the second clamping part; exemplary, The second clamping member in the present invention includes but is not limited to a T-shaped head.
本发明通过T型头的使用，能够使卡接更为牢固，从而有利于瓣膜的精准释放。Through the use of the T-shaped head, the present invention can make the clamping connection more firm, thereby facilitating the precise release of the valve.
优选地，所述连接件的数量与控制件的数量相同。Preferably, the number of the connecting parts is the same as the number of the control parts.
作为本发明的优选技术方案，所述连接件的数量与控制件的数量相同。进一步的，所述连接件的数量与瓣膜支腿的数量相同。As a preferred technical solution of the present invention, the number of the connecting parts is the same as the number of the control parts. Further, the number of the connecting parts is the same as the number of valve legs.
优选地，所述连接件包括连接延伸件与连接环；所述连接延伸件的近端与固定件连接，远端与连接环连接。Preferably, the connecting piece includes a connecting extension piece and a connecting ring; the proximal end of the connecting extending piece is connected to the fixing piece, and the distal end is connected to the connecting ring.
优选地，所述连接件均匀分布；进一步优选地，所述连接部内的连接环呈阶梯错位分布。Preferably, the connecting parts are evenly distributed; further preferably, the connecting rings in the connecting part are distributed in a stepwise dislocation.
优选地，所述控制件包括控制延伸件；所述控制延伸件的近端与基座连接，远端设置卡槽。Preferably, the control member includes a control extension; the proximal end of the control extension is connected to the base, and the distal end is provided with a card slot.
优选地，所述控制件均匀分布；进一步优选地，所述控制部内的卡槽阶梯错位分布。Preferably, the control parts are evenly distributed; further preferably, the card slots in the control part are distributed in steps.
作为本发明所述瓣膜释放组件的优选技术方案，应用本发明所述瓣膜释放组件时，瓣膜的支腿沿径向方向依次由外侧向内侧穿过连接环与卡槽，当需要释放瓣膜时，使控制部相对于连接部向近端移动，从而使支腿首先与卡槽分离。本领域所用瓣膜的材料为具有记忆金属特性的镍钛材料，在自膨力的作用下支腿进一步与连接环分离，从而实现了瓣膜的分步释放。As a preferred technical solution of the valve release assembly of the present invention, when the valve release assembly of the present invention is applied, the legs of the valve pass through the connecting ring and the card slot sequentially from the outside to the inside in the radial direction. When the valve needs to be released, The control part is moved to the proximal end relative to the connecting part, so that the supporting leg is first separated from the engaging slot. The material of the valve used in this field is a nickel-titanium material with memory metal properties, and the legs are further separated from the connecting ring under the action of self-expansion force, thereby realizing the step-by-step release of the valve.
第二方面，本发明提供了一种输送瓣膜的装置，所述装置包括如第一方面所述的瓣膜释放组件。In a second aspect, the present invention provides a device for delivering a valve, the device comprising the valve release assembly as described in the first aspect.
优选地，所述装置包括内芯组件、手柄组件、释放组件以及快撤组件；Preferably, the device includes an inner core assembly, a handle assembly, a release assembly and a quick release assembly;
所述内芯组件包括导向头、内芯、连接部、锁件与内导管；所述内芯的一端与导向头固定连接，另一端与锁件连接；所述锁件与内芯连接的相对端，与内导管连接；The inner core assembly includes a guide head, an inner core, a connecting portion, a lock and an inner conduit; one end of the inner core is fixedly connected to the guide head, and the other end is connected to the lock; the opposite end of the lock connected to the inner core end, connected with the inner catheter;
所述手柄组件包括前手柄外壳、外鞘管、外鞘固定件与手柄旋转件；所述内芯组件设置于外鞘管内部；所述外鞘管与设置于前手柄外壳内的外鞘固定件连接；所述手柄旋转件与外鞘固定件螺旋连接，手柄旋转件旋转以带动外鞘固定件沿轴向移动；The handle assembly includes a front handle shell, an outer sheath tube, an outer sheath fixing part and a handle rotating part; the inner core assembly is arranged inside the outer sheath tube; the outer sheath tube is fixed to the outer sheath arranged in the front handle shell The handle rotating part is spirally connected with the outer sheath fixing part, and the handle rotating part rotates to drive the outer sheath fixing part to move axially;
所述释放组件包括控制部、推送管以及推送手柄；所述推送管的一端与卡槽连接件连接，另一端与推送手柄连接；推送手柄控制推送管沿轴向移动；The release assembly includes a control part, a push tube and a push handle; one end of the push tube is connected to the slot connector, and the other end is connected to the push handle; the push handle controls the push tube to move axially;
所述推送手柄的外壳与前手柄外壳通过内部的外壳连接件相连；The shell of the push handle is connected to the front handle shell through an internal shell connector;
所述快撤组件包括固定导杆、推送管固定件与快撤旋钮；所述推送管固定件与快撤旋钮螺纹配合；所述固定导杆一端与外壳连接件连接，另一端与推送管固定件滑动连接。The quick withdrawal assembly includes a fixed guide rod, a push tube fixture and a quick withdrawal knob; the push tube fixture is threadedly matched with the quick withdrawal knob; one end of the fix guide rod is connected to the housing connector, and the other end is fixed to the push tube pieces slide connection.
本发明所述输送瓣膜的装置中，内芯组件的作用为固定瓣膜；手柄组件的作用为控制外鞘管的回收与释放；释放组件的作用为调整控制部与瓣膜支腿的连接；所述快撤组件的作用为瓣膜释放完成后，将内芯组件撤回外鞘管内，并将内芯组件与外鞘管一同撤出体外。In the valve delivery device of the present invention, the function of the inner core component is to fix the valve; the function of the handle component is to control the recovery and release of the outer sheath tube; the function of the release component is to adjust the connection between the control part and the valve legs; The function of the quick withdrawal component is to withdraw the inner core component into the outer sheath tube after the valve is released, and withdraw the inner core component and the outer sheath tube out of the body together.
本发明所述输送瓣膜的装置的结构简单，各部件相互配合，能够实现瓣膜的释放与全释放后的回收，并能够实现瓣膜的准确释放；所述全释放后的回收是指，瓣膜在完全膨开后，仍有支腿与连接件相连情况下的回收。其中，手柄组件中的手柄旋转件旋转以带动外鞘固定件沿轴向移动，从而实现外鞘管的轴向移动，进而实现了内芯组件所固定瓣膜的释放与回收；释放组件中推送手柄控制推送管沿轴向移动，从而实现控制部与连接部沿轴向的相对位移，实现瓣膜支腿与控制部以及连接部的分步分离，从而实现了瓣膜的分步稳定释放，也便于实现瓣膜完全膨开后的全释放回收；所述快撤组件的设置则能够实现瓣膜释放到位后对输送系统的快速回收，使导向头快速撤回到鞘管内一起随输送系统一起撤出体外，避免导向头在回撤过程中在外力作用下掉落在体内，提高了瓣膜的设置效率，进而减少了患者的痛苦。The valve delivery device of the present invention has a simple structure, and the components cooperate with each other to realize the release of the valve and the recovery after full release, and can realize the accurate release of the valve; the recovery after the full release means that the valve is fully released. After expanding, there is still recovery under the condition that the outrigger is connected with the connecting piece. Among them, the handle rotating part in the handle assembly rotates to drive the outer sheath fixing part to move in the axial direction, thereby realizing the axial movement of the outer sheath tube, and then realizing the release and recovery of the valve fixed by the inner core assembly; pushing the handle in the release assembly Control the push tube to move in the axial direction, so as to realize the relative displacement of the control part and the connecting part in the axial direction, and realize the step-by-step separation of the valve legs from the control part and the connecting part, so as to realize the step-by-step stable release of the valve and facilitate the realization of Full release and recovery after the valve is fully inflated; the setting of the quick withdrawal component can realize the rapid recovery of the delivery system after the valve is released in place, so that the guide head can be quickly withdrawn into the sheath and withdrawn from the body together with the delivery system to avoid guiding The head falls into the body under the action of external force during the withdrawal process, which improves the setting efficiency of the valve and reduces the pain of the patient.
优选地，所述内芯组件还包括设置于内导管外侧的挡件；Preferably, the inner core assembly further includes a stopper arranged outside the inner conduit;
所述推送管与卡槽连接件连接的一端设置有U型槽；所述挡件与U型槽配合，限制推送管的周向旋转。A U-shaped groove is provided at one end of the push pipe connected to the slot connector; the stopper cooperates with the U-shaped groove to limit the circumferential rotation of the push pipe.
本发明内芯组件通过挡件的设置，实现了对推送管周向旋转的限制，避免了瓣膜释放过程中对心肌内壁的损伤。The inner core assembly of the present invention realizes the limitation of the circumferential rotation of the push tube through the setting of the stopper, and avoids damage to the inner wall of the myocardium during the valve release process.
优选地，所述手柄组件还包括解锁件；所述解锁件通过轴向移动控制手柄旋转件的旋转锁止；Preferably, the handle assembly further includes an unlocking member; the unlocking member controls the rotation locking of the handle rotating member by moving axially;
优选地，所述解锁件设置有凸台，所述手柄旋转件的一端设置有限位卡槽，限位卡槽与凸台配合以实现手柄旋转件的旋转锁的与旋转解锁。Preferably, the unlocking part is provided with a boss, and one end of the handle rotating part is provided with a limiting slot, and the limiting slot cooperates with the boss to realize the rotation lock and rotation unlocking of the handle rotating part.
优选地，所述推送手柄包括推送手柄外壳、推送管密封腔、推送管行程件以及尾端旋钮；Preferably, the push handle includes a push handle housing, a push tube sealing cavity, a push tube travel member, and a tail knob;
所述推送管的近端与推送管密封腔连接；所述推送管密封腔与推送管行程件螺纹连接，以通过推送管行程螺纹的旋转控制推送管的轴向移动；The proximal end of the push tube is connected with the push tube sealing cavity; the push tube seal cavity is threadedly connected with the push tube travel member, so as to control the axial movement of the push tube through the rotation of the push tube stroke thread;
所述尾端旋钮设置有尾端凸台；推送管密封腔、尾端旋钮以及尾端凸台位于推送手柄外壳的内腔；所述推送管行程件位于尾端凸台的内腔；The tail end knob is provided with a tail end boss; the push tube sealing cavity, the tail end knob and the tail end boss are located in the inner cavity of the push handle shell; the push tube travel member is located in the inner cavity of the tail end boss;
所述尾端凸台的内腔设置导槽，推送管行程件的外壁设置凸起，导槽与凸起配合以使推送管行程件沿轴向移动。A guide groove is provided in the inner cavity of the boss at the tail end, and a protrusion is provided on the outer wall of the push tube travel member, and the guide groove cooperates with the protrusion to move the push pipe travel member in the axial direction.
优选地，所述导向头的形状为圆锥形。Preferably, the shape of the guide head is conical.
本发明所述导向头的材质为本领域常规材质，包括但不限于PEBAX(聚醚酰胺嵌段共聚物)弹性体。本发明通过导向头的使用，能够避免戳伤生物组织的内壁。The material of the guide head in the present invention is a conventional material in the field, including but not limited to PEBAX (polyetheramide block copolymer) elastomer. The present invention can avoid stabbing the inner wall of the biological tissue through the use of the guide head.
优选地，所述外鞘管与外鞘固定件的连接方式包括卡接、焊接或粘接中的任意一种或至少两种的组合。Preferably, the connection method between the outer sheath tube and the outer sheath fixing member includes any one or a combination of at least two of clamping, welding or bonding.
与现有技术相比，本发明的有益效果为：Compared with prior art, the beneficial effect of the present invention is:
（1）本发明提供的瓣膜释放组件与具有记忆金属特性的镍钛材料配合时，能够利用控制部与连接部的相对移动，在自膨力的作用下实现瓣膜与瓣膜释放组件的分步释放，从而解决了瓣膜在释放时的跑飞问题，使瓣膜释放更为准确；(1) When the valve release assembly provided by the present invention cooperates with the nickel-titanium material with memory metal properties, the relative movement of the control part and the connection part can be used to realize the step-by-step release of the valve and the valve release assembly under the action of self-expansion force , so as to solve the problem of the valve running away when it is released, and make the valve release more accurate;
（2）本发明所述输送瓣膜的装置的结构简单，各部件相互配合，能够实现瓣膜的释放与全释放后的回收，并能够实现瓣膜的准确释放；所述全释放后的回收是指，瓣膜在完全膨开后，仍有支腿与连接件相连情况下的回收。其中，手柄组件中的手柄旋转件旋转以带动外鞘固定件沿轴向移动，从而实现外鞘管的轴向移动，进而实现了内芯组件所固定瓣膜的释放与回收；释放组件中推送手柄控制推送管沿轴向移动，从而实现控制部与连接部沿轴向的相对位移，实现瓣膜支腿与控制部以及连接部的分步分离，从而实现了瓣膜的分步稳定释放；所述快撤组件的设置则能够实现瓣膜释放到位后对输送系统的快速回收，使导向头快速撤回到鞘管内一起随输送系统一起撤出体外，避免导向头在回撤过程中在外力作用下掉落在体内，提高了瓣膜的设置效率，进而减少了患者的痛苦。(2) The device for delivering the valve described in the present invention has a simple structure, and the components cooperate with each other to realize the release of the valve and the recovery after the full release, and can realize the accurate release of the valve; the recovery after the full release refers to, After the valve is fully inflated, it can still be recovered with the legs connected to the connector. Among them, the handle rotating part in the handle assembly rotates to drive the outer sheath fixing part to move in the axial direction, thereby realizing the axial movement of the outer sheath tube, and then realizing the release and recovery of the valve fixed by the inner core assembly; pushing the handle in the release assembly Control the push tube to move in the axial direction, so as to realize the relative displacement of the control part and the connecting part in the axial direction, and realize the step-by-step separation of the valve legs from the control part and the connecting part, so as to realize the step-by-step stable release of the valve; The setting of the withdrawal component can realize the rapid recovery of the delivery system after the valve is released in place, so that the guide head can be quickly withdrawn into the sheath and withdrawn from the body together with the delivery system, so as to avoid the guide head from falling on the ground under the action of external force during the withdrawal process. In vivo, the setting efficiency of the valve is improved, thereby reducing the pain of the patient.
附图说明Description of drawings
图1为实施例1中瓣膜释放组件的结构示意图；Fig. 1 is the structural schematic diagram of the valve releasing assembly in embodiment 1;
图2为实施例1中锁件的结构示意图；Fig. 2 is the structural representation of lock in embodiment 1;
图3为实施例1中连接部的结构示意图；Fig. 3 is the structural schematic diagram of connection part in embodiment 1;
图4为实施例1中控制部的结构示意图；Fig. 4 is the schematic structural diagram of the control part in embodiment 1;
图5为实施例1中瓣膜支腿与连接部以及控制部连接的示意图；Fig. 5 is a schematic diagram of the connection between the valve leg and the connection part and the control part in embodiment 1;
图6为实施例1中输送瓣膜的装置的结构示意图；6 is a schematic structural view of the device for delivering the valve in Example 1;
图7为实施例1中内芯组件的结构示意图；Fig. 7 is the structural representation of inner core assembly in embodiment 1;
图8为实施例1中手柄组件的结构示意图；Fig. 8 is the structural representation of handle assembly in embodiment 1;
图9与图10为实施例1中释放组件的结构示意图；9 and 10 are schematic structural views of the release assembly in Embodiment 1;
图11为实施例1中，释放组件中推送手柄的结构示意图；Fig. 11 is a schematic structural view of the push handle in the release assembly in embodiment 1;
图12为实施例1中快撤组件的结构示意图；Figure 12 is a schematic structural view of the quick-removal assembly in Embodiment 1;
图13为实施例1中快撤组件与内芯组件的连接关系图；Fig. 13 is a connection relation diagram between the quick-removal assembly and the inner core assembly in Embodiment 1;
图14为图13的局部放大图。FIG. 14 is a partially enlarged view of FIG. 13 .
其中：1，内芯组件；11，导向头；12，内芯；13，连接部；131，连接件；132，第一卡接件；14，锁件；15，内导管；16，挡件；2，手柄组件；21，前手柄外壳；22，外鞘管；23，外鞘固定件；24，手柄旋转件；25，解锁件；3，释放组件；31，控制部；311，控制件；312，第二卡接件；32，卡槽连接件；33，推送管；34，推送手柄外壳；35，衬套；36，推送管密封腔；37，推送管行程件；38，尾端旋钮；4，快撤组件；41，固定导杆；42，推送管固定件；43，快撤旋钮。Among them: 1, inner core assembly; 11, guide head; 12, inner core; 13, connecting part; 131, connecting piece; 132, first clamping piece; 14, locking piece; 15, inner catheter; 16, stop ;2, handle assembly; 21, front handle shell; 22, outer sheath tube; 23, outer sheath fixing part; 24, handle rotating part; 25, unlocking part; 3, release assembly; 31, control part; 311, control part ; Knob; 4, quick release assembly; 41, fixed guide rod; 42, push tube fixing piece; 43, quick release knob.
具体实施方式Detailed ways
需要理解的是，在本发明的描述中，术语“中心”、“纵向”、“横向”、“上”、“下”、“前”、“后”、“左”、“右”、“竖直”、“水平”、“顶”、“底”、“内”、“外”等指示的方位或位置关系为基于附图所示的方位或位置关系，仅是为了便于描述本发明和简化描述，而不是指示或暗示所指的装置或元件必须具有特定的方位、以特定的方位构造和操作，因此不能理解为对本发明的限制。It should be understood that in the description of the present invention, the terms "center", "longitudinal", "transverse", "upper", "lower", "front", "rear", "left", "right", " The orientations or positional relationships indicated by "vertical", "horizontal", "top", "bottom", "inner" and "outer" are based on the orientations or positional relationships shown in the drawings, and are only for the convenience of describing the present invention and Simplified descriptions, rather than indicating or implying that the device or element referred to must have a particular orientation, be constructed and operate in a particular orientation, and thus should not be construed as limiting the invention.
需要说明的是，在本发明的描述中，除非另有明确的规定和限定，术语“设置”、“相连”、“连接”应做广义理解，例如，可以是固定连接，也可以是可拆卸连接，或一体连接；可以是机械连接，也可以是电连接；可以是直接相连，也可以通过中间媒介间接相连，可以是两个元件内部的连通。对于本领域的普通技术人员而言，可以通过具体情况理解上述术语在本发明中的具体含义。It should be noted that, in the description of the present invention, unless otherwise clearly stipulated and limited, the terms "set", "connected" and "connected" should be understood in a broad sense, for example, it can be a fixed connection or a detachable connection. Connection, or integral connection; it can be mechanical connection or electrical connection; it can be direct connection or indirect connection through an intermediary, and it can be the internal communication of two components. Those of ordinary skill in the art can understand the specific meanings of the above terms in the present invention based on specific situations.
下面结合附图并通过具体实施方式来进一步说明本发明的技术方案。The technical solutions of the present invention will be further described below in conjunction with the accompanying drawings and through specific implementation methods.
在本发明提供的一个实施例中，本发明提供了一种瓣膜释放组件，所述瓣膜释放组件包括连接部、锁件、控制部与卡槽连接件；In one embodiment provided by the present invention, the present invention provides a valve release assembly, the valve release assembly includes a connecting part, a lock, a control part and a slot connecting part;
所述连接部包括固定件；所述固定件的一端设置连接件，另一端与锁件连接；The connecting part includes a fixing piece; one end of the fixing piece is provided with a connecting piece, and the other end is connected with the lock piece;
所述控制部包括基座；所述基座的一端设置控制件，另一端与卡槽连接件连接；The control part includes a base; one end of the base is provided with a control part, and the other end is connected with the slot connector;
所述锁件设置有与控制件对应的通孔；所述控制件穿设于锁件的对应通孔，分布于连接件的内侧。The lock piece is provided with a through hole corresponding to the control piece; the control piece passes through the corresponding through hole of the lock piece and is distributed inside the connecting piece.
应用所述瓣膜释放组件时，瓣膜的支腿沿径向方向依次由外侧向内侧穿过连接件与控制件，当需要释放瓣膜时，使控制部相对于连接部向近端移动，从而使支腿首先与控制件分离。本领域所用瓣膜的材料为具有记忆金属特性的镍钛材料，在自膨力的作用下支腿进一步与连接部分离，从而实现了瓣膜的分步释放。When using the valve release assembly, the legs of the valve pass through the connecting part and the control part sequentially from the outside to the inside in the radial direction. When the valve needs to be released, the control part is moved proximally relative to the connecting part, so that the support The legs are first separated from the controls. The material of the valve used in this field is a nickel-titanium material with memory metal properties, and the legs are further separated from the connecting part under the action of self-expansion force, thereby realizing the step-by-step release of the valve.
在某些实施例中，所述固定件设置连接件的相对端设置有第一卡接件；所述第一卡接件与锁件卡接。In some embodiments, the opposite end of the connecting part for setting the fixing part is provided with a first engaging part; the first engaging part is engaged with the locking part.
在某些实施例中，所述第一卡接件为T型头。In some embodiments, the first clamping member is a T-shaped head.
在某些实施例中，所述基座设置控制件的相对端设置有第二卡接件；所述第二卡接件与卡槽连接件卡接。In some embodiments, the opposite end of the base setting control part is provided with a second clamping part; the second clamping part is clamped with the slot connection part.
在某些实施例中，所述第二卡接件为T型头。In some embodiments, the second clamping member is a T-shaped head.
本发明通过T型头的使用，能够使卡接更为牢固，从而有利于瓣膜的精准释放。Through the use of the T-shaped head, the present invention can make the clamping connection more firm, thereby facilitating the precise release of the valve.
在某些实施例中，所述连接件的数量与控制件的数量相同。In some embodiments, the number of connecting elements is the same as the number of control elements.
在某些实施例中，所述连接件的数量与瓣膜支腿的数量相同。In some embodiments, the number of connectors is the same as the number of valve legs.
在某些实施例中，所述连接件包括连接延伸件与连接环；所述连接延伸件的近端与固定件连接，远端与连接环连接。In some embodiments, the connecting member includes a connecting extension and a connecting ring; the proximal end of the connecting extending member is connected to the fixing member, and the distal end is connected to the connecting ring.
在某些实施例中，所述连接件均匀分布，且所述连接部内的连接环呈阶梯错位分布。In some embodiments, the connecting elements are evenly distributed, and the connecting rings in the connecting portion are distributed in a stepwise dislocation manner.
在某些实施例中，所述控制件包括控制延伸件；所述控制延伸件的近端与基座连接，远端设置卡槽。In some embodiments, the control member includes a control extension; the proximal end of the control extension is connected to the base, and the distal end is provided with a card slot.
在某些实施例中，所述控制件均匀分布，且所述控制部内的卡槽阶梯错位分布。In some embodiments, the control members are evenly distributed, and the locking slots in the control portion are distributed in steps.
作为本发明所述瓣膜释放组件的优选技术方案，应用本发明所述瓣膜释放组件时，瓣膜的支腿沿径向方向依次由外侧向内侧穿过连接环与卡槽，当需要释放瓣膜时，使控制部相对于连接部向近端移动，从而使支腿首先与卡槽分离。本领域所用瓣膜的材料为具有记忆金属特性的镍钛材料，在自膨力的作用下支腿进一步与连接环分离，从而实现了瓣膜的分步释放。As a preferred technical solution of the valve release assembly of the present invention, when the valve release assembly of the present invention is applied, the legs of the valve pass through the connecting ring and the card slot sequentially from the outside to the inside in the radial direction. When the valve needs to be released, The control part is moved to the proximal end relative to the connecting part, so that the supporting leg is first separated from the engaging slot. The material of the valve used in this field is a nickel-titanium material with memory metal properties, and the legs are further separated from the connecting ring under the action of self-expansion force, thereby realizing the step-by-step release of the valve.
在本发明提供的另外一个实施例中，本发明提供了一种输送瓣膜的装置，所述装置包括上述瓣膜释放组件。In another embodiment provided by the present invention, the present invention provides a device for delivering a valve, the device comprising the above-mentioned valve release assembly.
在某些实施例中，所述装置包括内芯组件、手柄组件、释放组件以及快撤组件；In some embodiments, the device includes a core assembly, a handle assembly, a release assembly, and a quick release assembly;
所述内芯组件包括导向头、内芯、连接部、锁件与内导管；所述内芯的一端与导向头固定连接，另一端与锁件连接；所述锁件与内芯连接的相对端，与内导管连接；The inner core assembly includes a guide head, an inner core, a connecting portion, a lock and an inner conduit; one end of the inner core is fixedly connected to the guide head, and the other end is connected to the lock; the opposite end of the lock connected to the inner core end, connected with the inner catheter;
所述手柄组件包括前手柄外壳、外鞘管、外鞘固定件与手柄旋转件；所述内芯组件设置于外鞘管内部；所述外鞘管与设置于前手柄外壳内的外鞘固定件连接；所述手柄旋转件与外鞘固定件螺旋连接，手柄旋转件旋转以带动外鞘固定件沿轴向移动；The handle assembly includes a front handle shell, an outer sheath tube, an outer sheath fixing part and a handle rotating part; the inner core assembly is arranged inside the outer sheath tube; the outer sheath tube is fixed to the outer sheath arranged in the front handle shell The handle rotating part is spirally connected with the outer sheath fixing part, and the handle rotating part rotates to drive the outer sheath fixing part to move axially;
所述释放组件包括控制部、推送管以及推送手柄；所述推送管的一端与卡槽连接件连接，另一端与推送手柄连接；推送手柄控制推送管沿轴向移动；The release assembly includes a control part, a push tube and a push handle; one end of the push tube is connected to the slot connector, and the other end is connected to the push handle; the push handle controls the push tube to move axially;
所述推送手柄的外壳与前手柄外壳通过内部的外壳连接件相连；The shell of the push handle is connected to the front handle shell through an internal shell connector;
所述快撤组件包括固定导杆、推送管固定件与快撤旋钮；所述推送管固定件与快撤旋钮螺纹配合；所述固定导杆一端与推送管固定件连接，另一端与外鞘固定件连接。The quick withdrawal assembly includes a fixed guide rod, a push tube fixture and a quick withdrawal knob; the push tube fixture is threadedly matched with the quick withdrawal knob; one end of the fixed guide rod is connected to the push tube fixture, and the other end is connected to the outer sheath Fastener connection.
本发明所述输送瓣膜的装置中，内芯组件的作用为固定瓣膜；手柄组件的作用为控制外鞘管的回收与释放；释放组件的作用为调整控制部与瓣膜支腿的连接；所述快撤组件的作用为瓣膜释放完成后，将内芯组件撤回外鞘管内，并将内芯组件与外鞘管一同撤出体外。In the valve delivery device of the present invention, the function of the inner core component is to fix the valve; the function of the handle component is to control the recovery and release of the outer sheath tube; the function of the release component is to adjust the connection between the control part and the valve legs; The function of the quick withdrawal component is to withdraw the inner core component into the outer sheath tube after the valve release is completed, and withdraw the inner core component and the outer sheath tube out of the body together.
本发明所述输送瓣膜的装置的结构简单，各部件相互配合，能够实现瓣膜的释放与全释放后的回收，并能够实现瓣膜的准确释放；所述全释放后的回收是指，瓣膜在完全膨开后，仍有支腿与连接件相连情况下的回收。其中，手柄组件中的手柄旋转件旋转以带动外鞘固定件沿轴向移动，从而实现外鞘管的轴向移动，进而实现了内芯组件所固定瓣膜的释放与回收；释放组件中推送手柄控制推送管沿轴向移动，从而实现控制部与连接部沿轴向的相对位移，实现瓣膜支腿与控制部以及连接部的分布分离，从而实现了瓣膜的分步稳定释放；所述快撤组件的设置则能够实现瓣膜释放到位后对输送系统的快速回收，使导向头快速撤回到鞘管内一起随输送系统一起撤出体外，避免导向头在回撤过程中在外力作用下掉落在体内，提高了瓣膜的设置效率，进而减少了患者的痛苦。The valve delivery device of the present invention has a simple structure, and the components cooperate with each other to realize the release of the valve and the recovery after full release, and can realize the accurate release of the valve; the recovery after the full release means that the valve is fully released. After expanding, there is still recovery under the condition that the outrigger is connected with the connecting piece. Among them, the handle rotating part in the handle assembly rotates to drive the outer sheath fixing part to move in the axial direction, thereby realizing the axial movement of the outer sheath tube, and then realizing the release and recovery of the valve fixed by the inner core assembly; pushing the handle in the release assembly Control the push tube to move in the axial direction, so as to realize the relative displacement of the control part and the connecting part in the axial direction, and realize the distribution and separation of the valve legs from the control part and the connecting part, thereby realizing the step-by-step stable release of the valve; the quick withdrawal The setting of the components can realize the rapid recovery of the delivery system after the valve is released in place, so that the guide head can be quickly withdrawn into the sheath and withdrawn from the body together with the delivery system, preventing the guide head from falling into the body under the action of external force during the withdrawal process , improving the setting efficiency of the valve, thereby reducing the pain of the patient.
在某些实施例中，所述内芯组件还包括设置于内导管外侧的挡件。In some embodiments, the inner core assembly further includes a stopper disposed outside the inner conduit.
所述推送管与卡槽连接件连接的一端设置有U型槽；所述挡件与U型槽配合，限制推送管的周向旋转。A U-shaped groove is provided at one end of the push pipe connected to the slot connector; the stopper cooperates with the U-shaped groove to limit the circumferential rotation of the push pipe.
本发明内芯组件通过挡件的设置，实现了对推送管周向旋转的限制，避免了瓣膜释放过程中对血管内壁的损伤。The inner core assembly of the present invention realizes the limitation of the circumferential rotation of the push tube through the setting of the stopper, and avoids damage to the inner wall of the blood vessel during the valve release process.
在某些实施例中，所述手柄组件还包括解锁件；所述解锁件通过轴向移动控制手柄旋转件的旋转锁止。In some embodiments, the handle assembly further includes an unlocking part; the unlocking part controls the rotation lock of the handle rotating part by moving axially.
在某些实施例中，所述解锁件设置有凸台，所述手柄旋转件的一端设置有限位卡槽，限位卡槽与凸台配合以实现手柄旋转件的旋转锁的与旋转解锁。In some embodiments, the unlocking part is provided with a boss, and one end of the handle rotating part is provided with a limiting slot, and the limiting slot cooperates with the boss to realize the rotation lock and rotation unlocking of the handle rotating part.
在某些实施例中，所述推送手柄包括推送手柄外壳、推送管密封腔、推送管行程件以及尾端旋钮。In some embodiments, the push handle includes a push handle housing, a push tube sealing chamber, a push tube travel member, and a tail end knob.
所述推送管的近端与推送管密封腔连接；所述推送管密封腔与推送管行程件螺纹连接，以通过推送管行程螺纹的旋转控制推送管的轴向移动。The proximal end of the push tube is connected with the push tube sealing cavity; the push tube seal cavity is threadedly connected with the push tube stroke member, so as to control the axial movement of the push tube through the rotation of the push tube stroke thread.
所述尾端旋钮设置有尾端凸台；推送管密封腔、尾端旋钮以及尾端凸台位于推送手柄外壳的内腔；所述推送管行程件位于尾端凸台的内腔。The tail end knob is provided with a tail end boss; the sealing cavity of the push tube, the tail end knob and the tail end boss are located in the inner cavity of the push handle shell; the push tube travel member is located in the inner cavity of the tail end boss.
所述尾端凸台的内腔设置导槽，推送管行程件的外壁设置凸起，导槽与凸起配合以使推送管行程件沿轴向移动。A guide groove is provided in the inner cavity of the boss at the tail end, and a protrusion is provided on the outer wall of the push tube travel member, and the guide groove cooperates with the protrusion to move the push pipe travel member in the axial direction.
在某些实施例中，所述导向头的形状为圆锥形。In some embodiments, the shape of the guide head is conical.
本发明所述导向头的材质为本领域常规材质，包括但不限于PEBAX(聚醚酰胺嵌段共聚物)弹性体。本发明通过导向头的使用，能够避免戳伤生物组织的内壁。The material of the guide head in the present invention is a conventional material in the field, including but not limited to PEBAX (polyetheramide block copolymer) elastomer. The present invention can avoid stabbing the inner wall of the biological tissue through the use of the guide head.
在某些实施例中，所述外鞘管与外鞘固定件的连接方式包括卡接、焊接或粘接中的任意一种或至少两种的组合。In some embodiments, the connection method of the outer sheath tube and the outer sheath fixing member includes any one or a combination of at least two of clamping, welding or bonding.
实施例1Example 1
本实施例提供了一种输送瓣膜的装置，所述装置包括瓣膜释放组件3；This embodiment provides a device for delivering a valve, which includes a valve release assembly 3;
所述瓣膜释放组件的结构示意图如图1所示，包括连接部13、锁件14、控制部31与卡槽连接件32；所述连接部13包括固定件(参见图3)；所述固定件的一端设置均匀分布的连接件131，另一端设置有第一卡接件132，第一卡接件132与锁件14卡接；所述第一卡接件132为T型头；所述控制部31包括基座，所述基座的一端设置均匀分布的控制件311，另一端设置有第二卡接件312(参见图4)，第二卡接件312与卡槽连接件32卡接；所述第二卡接件312为T型头；所述锁件14设置有与控制件311对应的通孔(参见图2)；所述控制件311穿设于锁件14的对应通孔，分布于连接件131的内侧；The structure diagram of the valve release assembly is shown in Figure 1, including a connecting part 13, a lock 14, a control part 31 and a slot connecting part 32; the connecting part 13 includes a fixing part (see Figure 3); the fixing One end of the piece is provided with evenly distributed connectors 131, and the other end is provided with a first clamping piece 132, and the first clamping piece 132 is clamped with the lock piece 14; the first clamping piece 132 is a T-shaped head; the The control part 31 includes a base, one end of the base is provided with evenly distributed control members 311, and the other end is provided with a second clamping member 312 (see FIG. 4 ), the second clamping member 312 is engaged with the slot connector 32 connected; the second clamping piece 312 is a T-shaped head; the lock piece 14 is provided with a through hole corresponding to the control piece 311 (see FIG. 2 ); Holes are distributed on the inner side of the connector 131;
所述连接件131包括连接延伸件与连接环；所述连接延伸件的近端与固定件连接，远端与连接环连接；所述控制件311包括控制延伸件；所述控制延伸件的近端与基座连接，远端设置卡槽；The connecting part 131 includes a connecting extension and a connecting ring; the proximal end of the connecting extending part is connected with the fixing part, and the far end is connected with the connecting ring; the control part 311 includes a control extending part; the near end of the controlling extending part The end is connected to the base, and the far end is provided with a card slot;
所述连接件131的数量、控制件311的数量以及瓣膜支腿的数量相同，且连接部13内的连接环呈阶梯错位分布，控制部31内的卡槽阶梯错位分布。The number of the connecting parts 131 , the number of the control parts 311 and the number of valve legs are the same, and the connecting rings in the connecting part 13 are distributed in steps and the slots in the control part 31 are distributed in steps.
应用所述瓣膜释放组件时，瓣膜的支腿沿径向方向依次由外侧向内侧穿过连接环与卡槽(参见图5)，当需要释放瓣膜时，使控制部31相对于连接部13向近端移动，从而使支腿首先与卡槽分离。所述瓣膜的材料为具有记忆金属特性的镍钛材料，在自膨力的作用下支腿进一步与连接环分离，从而实现了瓣膜的分步释放。When using the valve release assembly, the legs of the valve pass through the connecting ring and the slot from the outside to the inside in the radial direction (see Figure 5). The proximal end moves so that the legs are first separated from the slots. The material of the valve is nickel-titanium material with memory metal properties, and the legs are further separated from the connecting ring under the action of self-expansion force, thereby realizing the step-by-step release of the valve.
所述装置的结构示意图如图6所示，包括内芯组件1、手柄组件2、释放组件3以及快撤组件4；The structural diagram of the device is shown in Figure 6, including an inner core component 1, a handle component 2, a release component 3 and a quick withdrawal component 4;
所述内芯组件1的结构示意图如图7所示，包括圆锥形导向头11、内芯12、连接部13、锁件14与内导管15；所述内芯12的一端与导向头11固定连接，另一端与锁件14连接；所述锁件14与内芯12连接的相对端，与内导管15连接；所述内芯组件1还包括设置于内导管15外侧的挡件16；The schematic structural view of the inner core assembly 1 is shown in Figure 7, including a conical guide head 11, an inner core 12, a connecting portion 13, a lock 14 and an inner conduit 15; one end of the inner core 12 is fixed to the guide head 11 Connected, the other end is connected with the lock piece 14; the opposite end of the lock piece 14 connected with the inner core 12 is connected with the inner conduit 15; the inner core assembly 1 also includes a stopper 16 arranged on the outside of the inner conduit 15;
所述手柄组件2的结构示意图如图8所示，包括前手柄外壳21、外鞘管22、外鞘固定件23与手柄旋转件24；所述内芯组件1设置于外鞘管22内部；所述外鞘管22与设置于前手柄外壳21内的外鞘固定件23粘接；所述手柄旋转件24与外鞘固定件23螺旋连接，手柄旋转件24旋转以带动外鞘固定件23沿轴向移动；The structural schematic diagram of the handle assembly 2 is shown in FIG. 8 , including a front handle shell 21, an outer sheath tube 22, an outer sheath fixing member 23 and a handle rotating member 24; the inner core assembly 1 is arranged inside the outer sheath tube 22; The outer sheath tube 22 is bonded to the outer sheath fixing part 23 arranged in the front handle shell 21; the handle rotating part 24 is spirally connected with the outer sheath fixing part 23, and the handle rotating part 24 rotates to drive the outer sheath fixing part 23 move along the axis;
所述手柄组件2还包括解锁件25，所述解锁件25设置有凸台，所述手柄旋转件24的一端设置有限位卡槽，限位卡槽与凸台配合以实现手柄旋转件24的旋转锁的与旋转解锁；The handle assembly 2 also includes an unlocking part 25, the unlocking part 25 is provided with a boss, and one end of the handle rotating part 24 is provided with a limit card slot, and the limit card slot cooperates with the boss to realize the handle rotating part 24. Rotate lock and rotate unlock;
所述释放组件3的结构示意图如图9与图10所示，包括控制部31、推送管33以及推送手柄；所述推送管33的一端与卡槽连接件32连接，另一端与推送手柄连接；推送手柄控制推送管33沿轴向移动；具体的：所述推送手柄(参见图11)包括推送手柄外壳34、衬套35、推送管密封腔36、推送管行程件37以及尾端旋钮38；所述推送管33的近端与推送管密封腔36连接；所述推送管密封腔36与推送管行程件37螺纹连接，以通过推送管33行程螺纹的旋转控制推送管33的轴向移动；所述尾端旋钮38设置有尾端凸台；推送管密封腔36、尾端旋钮38以及尾端凸台位于推送手柄外壳34的内腔；所述推送管行程件37位于尾端凸台的内腔；所述尾端凸台的内腔设置导槽，推送管行程件37的外壁设置凸起，导槽与凸起配合以使快撤时，尾端旋钮38保持不动，而推送管行程件37及推送管33、衬套35与推送管密封腔36沿轴向移动；所述推送管33与卡槽连接件32连接的一端设置有U型槽；所述挡件16与U型槽配合，限制推送管33的周向旋转；The structure diagram of the release assembly 3 is shown in Figure 9 and Figure 10, including a control part 31, a push tube 33 and a push handle; one end of the push tube 33 is connected to the slot connector 32, and the other end is connected to the push handle The push handle controls the push tube 33 to move axially; specifically: the push handle (see FIG. 11 ) includes a push handle housing 34, a bushing 35, a push tube sealing chamber 36, a push tube travel member 37 and a tail end knob 38 The proximal end of the push tube 33 is connected with the push tube seal chamber 36; the push tube seal cavity 36 is threaded with the push tube stroke member 37, so as to control the axial movement of the push tube 33 by the rotation of the push tube 33 stroke threads The tail end knob 38 is provided with a tail end boss; the push tube sealing cavity 36, the tail end knob 38 and the tail end boss are located in the inner cavity of the push handle shell 34; the push tube travel member 37 is located at the tail end boss The inner chamber of the boss at the tail end is provided with a guide groove, and the outer wall of the push tube travel member 37 is provided with a protrusion, and the guide groove cooperates with the protrusion so that when withdrawing quickly, the tail end knob 38 remains motionless and pushes The pipe stroke member 37, the push pipe 33, the bushing 35 and the push pipe sealing cavity 36 move axially; the end of the push pipe 33 connected to the groove connector 32 is provided with a U-shaped groove; the stopper 16 and the U The groove fits to limit the circumferential rotation of the push tube 33;
所述推送手柄外壳34与前手柄外壳21通过内腔的外壳连接件131相连；The push handle shell 34 is connected to the front handle shell 21 through the shell connector 131 of the inner cavity;
所述快撤组件4(参见图12)包括固定导杆41、推送管固定件42与快撤旋钮43，其与内芯组件1的连接关系图如图13所示；所述推送管固定件42的外表面设置外螺纹，与快撤旋钮43的内螺纹相配合；所述固定导杆41一端与外壳连接件131连接，另一端与推送管固定件42滑动连接；所述推送管固定件42的内部将衬套35以及推送管密封腔36连接为一体(参见图14)；旋转快撤旋钮43带动推送管固定件42及其内腔的零件向近端移动，从而将内芯组件1撤回外鞘管22；。The quick-removal assembly 4 (see FIG. 12 ) includes a fixed guide rod 41, a push tube fixing member 42 and a quick-removal knob 43, and its connection diagram with the inner core assembly 1 is shown in FIG. 13; the push tube fixing member The outer surface of 42 is provided with an external thread, which matches the internal thread of the quick release knob 43; one end of the fixed guide rod 41 is connected to the shell connector 131, and the other end is slidably connected to the push tube fixer 42; the push tube fixer The interior of 42 connects the bushing 35 and the sealing cavity 36 of the push tube as a whole (see Figure 14); the quick release knob 43 drives the push tube fixture 42 and the parts of its inner cavity to move to the proximal end, thereby moving the inner core assembly 1 Withdraw the outer sheath tube 22;.
本实施例提供的输送瓣膜的装置中，手柄组件2中的手柄旋转件24旋转以带动外鞘固定件23沿轴向移动，从而实现外鞘管22的轴向移动，进而实现了内芯组件1所固定瓣膜的释放与全释放后的回收；释放组件3中推送手柄控制推送管33沿轴向移动，从而实现控制部31与连接部13沿轴向的相对位移，实现瓣膜支腿与控制部31以及连接部13的分布分离，从而实现了瓣膜的分步稳定释放；所述快撤组件4的设置则能够实现瓣膜释放到位后对输送系统的快速回收，使导向头11快速撤回到鞘管内一起随输送系统一起撤出体外，避免导向头11在回撤过程中在外力作用下掉落在体内，提高了瓣膜的设置效率，进而减少了患者的痛苦。因此，本实施例提供的输送瓣膜的装置的结构简单，各部件相互配合，能够实现瓣膜的释放与回收，并能够实现瓣膜的准确释放。In the valve delivery device provided in this embodiment, the handle rotating part 24 in the handle assembly 2 rotates to drive the outer sheath fixing part 23 to move axially, thereby realizing the axial movement of the outer sheath tube 22 and realizing the inner core assembly 1 The release of the fixed valve and the recovery after full release; the push handle in the release assembly 3 controls the push tube 33 to move in the axial direction, so as to realize the relative displacement of the control part 31 and the connecting part 13 in the axial direction, and realize the valve leg and control The distribution and separation of the connecting part 31 and the connecting part 13, thereby realizing the step-by-step stable release of the valve; the setting of the quick withdrawal component 4 can realize the rapid recovery of the delivery system after the valve is released in place, so that the guide head 11 can be quickly withdrawn to the sheath The inside of the tube is withdrawn from the body together with the delivery system, which prevents the guide head 11 from falling into the body under the action of external force during the withdrawal process, improves the setting efficiency of the valve, and reduces the pain of the patient. Therefore, the device for delivering the valve provided by this embodiment has a simple structure, and the components cooperate with each other to realize the release and recovery of the valve, and realize the accurate release of the valve.
综上所述，本发明提供的瓣膜释放组件与具有记忆金属特性的镍钛材料配合时，能够利用控制部与连接部的相对移动，在自膨力的作用下实现瓣膜与瓣膜释放组件的分步释放，从而解决了瓣膜在释放时的跑飞问题，使瓣膜释放更为准确；本发明所述输送瓣膜的装置的结构简单，各部件相互配合，能够实现瓣膜的释放与全释放后的回收，并能够实现瓣膜的准确释放；所述全释放后的回收是指，瓣膜在完全膨开后，仍有支腿与连接件相连情况下的回收。其中，手柄组件中的手柄旋转件旋转以带动外鞘固定件沿轴向移动，从而实现外鞘管的轴向移动，进而实现了内芯组件所固定瓣膜的释放与回收；释放组件中推送手柄控制推送管沿轴向移动，从而实现控制部与连接部沿轴向的相对位移，实现瓣膜支腿与控制部以及连接部的分步分离，从而实现了瓣膜的分步稳定释放；所述快撤组件的设置则能够实现瓣膜释放到位后对输送系统的快速回收，使导向头快速撤回到鞘管内一起随输送系统一起撤出体外，避免导向头在回撤过程中在外力作用下掉落在体内，提高了瓣膜的设置效率，进而减少了患者的痛苦。In summary, when the valve release assembly provided by the present invention cooperates with the nickel-titanium material with memory metal properties, the relative movement of the control part and the connection part can be used to realize the separation of the valve and the valve release assembly under the action of self-expanding force. step-by-step release, thereby solving the problem of the valve running away during release, and making the valve release more accurate; the device for delivering the valve described in the present invention has a simple structure, and the components cooperate with each other to realize the release of the valve and the recovery after full release , and can realize the accurate release of the valve; the recovery after full release refers to the recovery under the condition that the outrigger is still connected to the connecting part after the valve is fully inflated. Among them, the handle rotating part in the handle assembly rotates to drive the outer sheath fixing part to move in the axial direction, thereby realizing the axial movement of the outer sheath tube, and then realizing the release and recovery of the valve fixed by the inner core assembly; pushing the handle in the release assembly Control the push tube to move in the axial direction, so as to realize the relative displacement of the control part and the connecting part in the axial direction, and realize the step-by-step separation of the valve legs from the control part and the connecting part, so as to realize the step-by-step stable release of the valve; The setting of the withdrawal component can realize the rapid recovery of the delivery system after the valve is released in place, so that the guide head can be quickly withdrawn into the sheath and withdrawn from the body together with the delivery system, so as to avoid the guide head from falling on the ground under the action of external force during the withdrawal process. In vivo, the setting efficiency of the valve is improved, thereby reducing the pain of the patient.
以上所述仅为本发明的具体实施方式，但本发明的保护范围并不局限于此，所属技术领域的技术人员应该明了，任何属于本技术领域的技术人员在本发明揭露的技术范围内，可轻易想到的变化或替换，均落在本发明的保护范围和公开范围之内。The above is only a specific embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Those skilled in the art should understand that any person skilled in the art is within the technical scope disclosed in the present invention. Easily conceivable changes or substitutions all fall within the scope of protection and disclosure of the present invention.
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202310572705.XACN116269943B (en) | 2023-05-22 | 2023-05-22 | A valve release component and a device for delivering a valve |
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202310572705.XACN116269943B (en) | 2023-05-22 | 2023-05-22 | A valve release component and a device for delivering a valve |
| Publication Number | Publication Date |
|---|---|
| CN116269943A CN116269943A (en) | 2023-06-23 |
| CN116269943Btrue CN116269943B (en) | 2023-09-01 |
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202310572705.XAActiveCN116269943B (en) | 2023-05-22 | 2023-05-22 | A valve release component and a device for delivering a valve |
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| CN (1) | CN116269943B (en) |
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
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| CN102196784A (en)* | 2008-08-22 | 2011-09-21 | 爱德华兹生命科学公司 | Prosthetic heart valve and delivery apparatus |
| CN208725960U (en)* | 2017-08-25 | 2019-04-12 | 上海微创心通医疗科技有限公司 | The conveying device of self-expanding prosthese and the conveying device of self-expanding heart valve prosthesis |
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| CN109350311A (en)* | 2018-12-14 | 2019-02-19 | 宁波健世生物科技有限公司 | A kind of valve bracket of controlled release |
| CN209916301U (en)* | 2018-12-29 | 2020-01-10 | 杭州德晋医疗科技有限公司 | Single-window guided valve ring-contracting system |
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| Date | Code | Title | Description |
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| PB01 | Publication | ||
| PB01 | Publication | ||
| SE01 | Entry into force of request for substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| GR01 | Patent grant | ||
| GR01 | Patent grant | ||
| PE01 | Entry into force of the registration of the contract for pledge of patent right | Denomination of invention:A valve release component and device for delivering valves Granted publication date:20230901 Pledgee:China Minsheng Banking Corp Shanghai branch Pledgor:SHANGHAI CINGULAR BIOTECH Corp. Registration number:Y2024310001261 | |
| PE01 | Entry into force of the registration of the contract for pledge of patent right |