CN116746987A - Cutting and collecting catheter and intravascular calcified plaque removing device - Google Patents
Cutting and collecting catheter and intravascular calcified plaque removing device Download PDFInfo
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- VTYYLEPIZMXCLO-UHFFFAOYSA-L Calcium carbonate Chemical compound [Ca+2].[O-]C([O-])=O VTYYLEPIZMXCLO-UHFFFAOYSA-L 0.000 description 2
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/32—Surgical cutting instruments
- A61B17/3205—Excision instruments
- A61B17/3207—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
- A61B17/320758—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions with a rotating cutting instrument, e.g. motor driven
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/32—Surgical cutting instruments
- A61B17/3205—Excision instruments
- A61B17/3207—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
- A61B17/320783—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions through side-hole, e.g. sliding or rotating cutter inside catheter
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/32—Surgical cutting instruments
- A61B17/3205—Excision instruments
- A61B17/3207—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
- A61B2017/320716—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions comprising means for preventing embolism by dislodged material
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/32—Surgical cutting instruments
- A61B17/3205—Excision instruments
- A61B17/3207—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
- A61B2017/320741—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions for stripping the intima or the internal plaque from a blood vessel, e.g. for endarterectomy
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Abstract
Description
技术领域Technical field
本发明涉及医疗器械技术领域,尤其涉及一种切割和收集导管及血管内钙化斑块去除装置。The present invention relates to the technical field of medical devices, and in particular to a cutting and collecting catheter and an intravascular calcified plaque removal device.
背景技术Background technique
钙化斑块是由于脂肪、血栓、结蹄组织和碳酸钙在血管内壁沉积所造成的对人体有害的物质,钙化斑块的存在会使血管管腔狭窄、血流不畅,严重时会导致器官供血不足,斑块破裂甚至会堵塞血管,引起患者器官急性缺血现象。因此,有必要对血管内的钙化斑块进行去除。Calcified plaque is a substance harmful to the human body caused by the deposition of fat, thrombus, connective tissue and calcium carbonate on the inner wall of blood vessels. The presence of calcified plaque can narrow the lumen of the blood vessel and impede blood flow. In severe cases, it can cause organ damage. Insufficient blood supply, plaque rupture may even block blood vessels, causing acute ischemia of the patient's organs. Therefore, it is necessary to remove calcified plaque in blood vessels.
现有的钙化斑块去除装置的导管包括管体及设于管体内的切刀,切刀与电机连接,在电机的驱动下旋转切割人体血管中的钙化斑。然而,这种钙化斑块去除装置的导管在切除钙化斑的过程中产生了大量的碎块,并未做任何处理,钙化斑碎块存留在血管中,可能形成栓塞并造成问题。The catheter of the existing calcified plaque removal device includes a tube body and a cutter installed in the tube body. The cutter is connected to a motor and is driven by the motor to rotate and cut calcified plaques in human blood vessels. However, the catheter of this calcified plaque removal device generates a large amount of fragments during the removal of calcified plaques without any treatment. The calcified plaque fragments remain in the blood vessels and may form embolisms and cause problems.
发明内容Contents of the invention
本发明的主要目的在于提供一种切割和收集导管及血管内钙化斑块去除装置,旨在实现在去除血管内钙化斑块的同时收集钙化斑碎块,以避免钙化斑碎块存留在体内血管中。The main purpose of the present invention is to provide a cutting and collecting catheter and an intravascular calcified plaque removal device, which aims to collect calcified plaque fragments while removing intravascular calcified plaque, so as to avoid calcified plaque fragments remaining in blood vessels in the body. middle.
为实现上述目的,本发明提出一种切割和收集导管,包括:In order to achieve the above object, the present invention proposes a cutting and collecting catheter, including:
管体,设有显露口;The pipe body is provided with an exposure port;
切割部件,旋转设置于所述管体内并位于所述显露口处,所述切割部件用于旋转切割血管内钙化斑块;以及A cutting component, which is rotatably installed in the tube body and located at the exposure port, and is used to rotate and cut intravascular calcified plaque; and
收集部件,与所述管体一体成型或设于所述管体内,所述收集部件用于收集切割过程中产生的钙化斑碎块。A collection component is integrally formed with or provided in the tube body. The collection component is used to collect calcified plaque fragments generated during the cutting process.
可选地,所述切割部件包括刀座和刀头,所述刀座适于通过传动轴与驱动组件驱动连接,所述刀座上设有凸柱,所述刀头上对应所述凸柱的位置设有与其适配的安装孔,所述凸柱插设于所述安装孔中并通过焊接或粘接固定。Optionally, the cutting component includes a cutter holder and a cutter head. The cutter holder is suitable for driving connection with the driving assembly through a transmission shaft. The cutter holder is provided with a protruding column, and the cutter head corresponds to the protruding column. is provided with a matching mounting hole, and the protruding column is inserted into the mounting hole and fixed by welding or bonding.
可选地,所述刀头的刀刃向轴心偏转α角,以使所述刀头的刀刃与人体血管壁平行。Optionally, the cutting edge of the cutter head is deflected toward the axis by an angle α so that the cutting edge of the cutter head is parallel to the blood vessel wall of the human body.
可选地,所述切割部件还包括切刀停泊件和/或切刀调整件,所述切刀停泊件设于所述管体的近端内部并用于在所述切割部件工作时供其停靠,所述切刀调整件部分插设于所述管体的近端内部并用于在所述切割部件工作时顶住所述收集部件。Optionally, the cutting part further includes a cutter parking part and/or a cutter adjustment part. The cutter parking part is provided inside the proximal end of the tube body and is used for docking the cutting part when it is working. , the cutter adjustment piece is partially inserted inside the proximal end of the tube body and used to resist the collection component when the cutting component is working.
可选地,所述收集部件包括骨架、第一导丝腔体及第一显影件,所述骨架、所述第一导丝腔体与第一显影件层压热缩或注塑包胶形成收集管主体,所述骨架呈镂空状,所述第一导丝腔体形成有供导丝通过的第一导丝腔道,所述第一显影件设于所述第一导丝腔体内,所述第一显影件用于在影像设备探测下显影,以在所述切割和收集导管进入人体后标记所述收集部件所处位置;和/或Optionally, the collection component includes a skeleton, a first guide wire cavity and a first developing member, and the skeleton, the first guide wire cavity and the first developing member are laminated and heat-shrunk or injection molded to form a collecting member. The main body of the tube, the skeleton is hollow, the first guide wire cavity is formed with a first guide wire cavity for the guide wire to pass through, the first developing member is arranged in the first guide wire cavity, so The first developing member is used to develop under detection by imaging equipment to mark the location of the collection component after the cutting and collection catheter enters the human body; and/or
所述收集部件具有弯型段,所述弯型段用于使所述切割部件贴近钙化斑块所处的血管壁一侧。The collecting component has a curved section, and the curved section is used to bring the cutting component close to the side of the blood vessel wall where the calcified plaque is located.
可选地,所述切割和收集导管还包括设置于所述管体远端的尖头组件,所述尖头组件整体呈锥形。Optionally, the cutting and collecting catheter further includes a tip assembly disposed at the distal end of the tube body, and the tip assembly is tapered as a whole.
可选地,所述尖头组件包括支撑件、连接件、第二导丝腔体及第二显影件,所述支撑件、所述连接件、所述第二导丝腔体与所述第二显影件层压热缩或注塑包胶形成尖头主体,所述支撑件与所述收集部件连接,所述连接件嵌设于所述尖头主体中,所述第二导丝腔体设有供导丝通过的第二导丝腔道,所述第二显影件设于所述第二导丝腔体内,所述第二显影件用于在影像设备探测下显影,以在所述切割和收集导管进入人体后标记所述尖头组件所处位置。Optionally, the tip assembly includes a support member, a connecting member, a second guide wire cavity and a second developing member, and the support member, the connecting member, the second guide wire cavity and the third developing member The two developing parts are laminated and heat-shrunk or injection-molded to form a pointed body, the support member is connected to the collecting component, the connecting piece is embedded in the pointed body, and the second guide wire cavity is provided with There is a second guidewire lumen for the guidewire to pass through, and the second developing member is provided in the second guidewire cavity. The second developing member is used for developing under detection by an imaging device to perform the cutting operation. After the collection catheter enters the human body, the position of the pointed assembly is marked.
为实现上述目的,本发明还提出一种血管内钙化斑块去除装置,包括:In order to achieve the above object, the present invention also proposes an intravascular calcified plaque removal device, including:
驱动组件;drive components;
输送导管,所述输送导管的近端固定在所述驱动组件上;以及a delivery catheter with a proximal end secured to the drive assembly; and
如上所述的切割和收集导管,固定在所述输送导管的远端上并与所述驱动组件驱动连接,所述驱动组件用于驱动所述切割和收集导管的切割部件旋转以切割血管内钙化斑块;所述切割和收集导管包括:The cutting and collecting catheter as described above is fixed on the distal end of the delivery catheter and is drivingly connected to the driving assembly. The driving assembly is used to drive the cutting component of the cutting and collecting catheter to rotate to cut intravascular calcification. Plaque; the cutting and collection catheter includes:
管体,设有显露口;The pipe body is provided with an exposure port;
切割部件,旋转设置于所述管体内并位于所述显露口处,所述切割部件用于旋转切割血管内钙化斑块;以及A cutting component, which is rotatably installed in the tube body and located at the exposure port, and is used to rotate and cut intravascular calcified plaque; and
收集部件,与所述管体一体成型或设于所述管体的远端,所述收集部件用于收集切割过程中产生的钙化斑碎块。A collection component is integrally formed with the tube body or is provided at the distal end of the tube body. The collection component is used to collect calcified plaque fragments generated during the cutting process.
可选地,所述输送导管包括螺旋扭力管、防漏膜及金属编织网,所述螺旋扭力管、所述防漏膜与所述金属编织网通过层压热缩或注塑包胶形成导管主体;和/或Optionally, the delivery conduit includes a spiral torsion tube, a leak-proof membrane and a metal braided mesh, and the spiral torsion tube, the leak-proof membrane and the metal braided mesh are laminated and heat-shrunk or injection-molded to form a catheter body. ;and / or
所述输送导管具有固定弯管段,所述固定弯管段适于贴靠于血管壁上并用于为所述切割部件提供支撑力,以使其贴近钙化斑块所处的血管壁一侧。The delivery catheter has a fixed elbow section that is adapted to abut against the blood vessel wall and is used to provide supporting force for the cutting component so that it is close to the side of the blood vessel wall where the calcified plaque is located.
可选地,所述驱动组件还用于控制所述切割部件的刀刃在切割钙化斑时抬起预设高度,所述预设高度适于小于血管壁厚。Optionally, the driving assembly is also used to control the blade of the cutting component to lift to a preset height when cutting calcification plaques, and the preset height is suitable to be smaller than the blood vessel wall thickness.
在本发明的技术方案中,该切割和收集导管包括管体、切割部件以及收集部件;管体设有显露口;切割部件旋转设置于管体内并位于显露口处,切割部件用于旋转切割血管内钙化斑块;收集部件与管体一体成型或设于管体的远端,收集部件用于收集切割过程中产生的钙化斑碎块。如此,通过设置切割部件旋转切割血管内钙化斑块,同时收集部件收集切割过程中产生的钙化斑碎块,有效去除了血管内钙化斑块,并避免了钙化斑碎块存留在体内血管中。In the technical solution of the present invention, the cutting and collecting catheter includes a tube body, a cutting part and a collecting part; the tube body is provided with an exposure port; the cutting part is rotatably arranged in the tube body and located at the exposure port, and the cutting part is used to rotate and cut blood vessels Internal calcified plaque; the collection component is integrally formed with the tube body or is located at the distal end of the tube body, and the collection component is used to collect calcified plaque fragments generated during the cutting process. In this way, by setting the cutting part to rotate and cut the calcified plaque in the blood vessel, and at the same time, the collecting part collects the calcified plaque fragments generated during the cutting process, which effectively removes the calcified plaque in the blood vessel and prevents the calcified plaque fragments from remaining in the blood vessels in the body.
附图说明Description of the drawings
为了更清楚地说明本发明实施例或现有技术中的技术方案,下面将对实施例或现有技术描述中所需要使用的附图作简单地介绍,显而易见地,下面描述中的附图仅仅是本发明的一些实施例,对于本领域普通技术人员来讲,在不付出创造性劳动的前提下,还可以根据这些附图示出的结构获得其他的附图。In order to explain the embodiments of the present invention or the technical solutions in the prior art more clearly, the drawings needed to be used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings in the following description are only These are some embodiments of the present invention. For those of ordinary skill in the art, other drawings can be obtained based on the structures shown in these drawings without exerting creative efforts.
图1为本发明切割和收集导管一实施例的结构示意图;Figure 1 is a schematic structural diagram of an embodiment of the cutting and collecting catheter of the present invention;
图2为本发明切割和收集导管一实施例的结构细化图;Figure 2 is a detailed structural view of an embodiment of the cutting and collection catheter of the present invention;
图3为本发明切割和收集导管一实施例中切除钙化斑的示意图;Figure 3 is a schematic diagram of removing calcified plaques in one embodiment of the cutting and collecting catheter of the present invention;
图4为本发明切割和收集导管一实施例中收集部件弯型段的结构示意图;Figure 4 is a schematic structural diagram of the curved section of the collection component in one embodiment of the cutting and collection catheter of the present invention;
图5为本发明切割和收集导管一实施例中处于工作状态时刀头的抬高高度和刀刃角度示意图;Figure 5 is a schematic diagram of the elevation height and blade angle of the cutter head when the cutting and collecting catheter is in working state according to an embodiment of the present invention;
图6为本发明切割和收集导管一实施例中切割部件的结构示意图;Figure 6 is a schematic structural diagram of the cutting component in one embodiment of the cutting and collecting catheter of the present invention;
图7为本发明切割和收集导管一实施例中切割部件的爆炸图;Figure 7 is an exploded view of the cutting component in one embodiment of the cutting and collecting catheter of the present invention;
图8为本发明血管内钙化斑块去除装置一实施例的结构示意图;Figure 8 is a schematic structural diagram of an embodiment of the intravascular calcified plaque removal device of the present invention;
图9为本发明血管内钙化斑块去除装置一实施例中输送导管的结构示意图。Figure 9 is a schematic structural diagram of a delivery catheter in an embodiment of the intravascular calcified plaque removal device of the present invention.
附图标号说明:Explanation of reference numbers:
100、切割和收集导管;200、输送导管;300、驱动组件;10、管体;20、切割部件;30、收集部件;40、尖头组件;10a、显露口;101、血管;102、钙化斑块;21、刀座;22、刀头;23、传动轴;211、凸柱;22a、安装孔;24、切刀停泊件;25、切刀调整件;31、骨架;32、第一导丝腔体;33、第一显影件;310、收集管主体;41、支撑件;42、连接件;43、第二导丝腔体;44、第二显影件;410、尖头主体;210、螺旋扭力管;220、防漏膜;230、金属编织网;240、导管主体;301、弯型段;201、固定弯管段。100. Cutting and collecting catheter; 200. Delivery catheter; 300. Driving component; 10. Tube body; 20. Cutting component; 30. Collection component; 40. Tip assembly; 10a. Exposure port; 101. Blood vessel; 102. Calcification Plaque; 21. Knife holder; 22. Cutter head; 23. Drive shaft; 211. Boss; 22a. Mounting hole; 24. Cutter parking piece; 25. Cutter adjustment piece; 31. Skeleton; 32. First Guide wire cavity; 33. First developing member; 310. Collection tube main body; 41. Support member; 42. Connector; 43. Second guide wire cavity; 44. Second developing member; 410. Tip body; 210. Spiral torque tube; 220. Leak-proof membrane; 230. Metal braided mesh; 240. Conduit main body; 301. Bend section; 201. Fixed bend section.
本发明目的的实现、功能特点及优点将结合实施例,参照附图做进一步说明。The realization of the purpose, functional features and advantages of the present invention will be further described with reference to the embodiments and the accompanying drawings.
具体实施方式Detailed ways
下面将结合本发明实施例中的附图,对本发明实施例中的技术方案进行清楚、完整地描述,显然,所描述的实施例仅仅是本发明的一部分实施例,而不是全部的实施例。基于本发明中的实施例,本领域普通技术人员在没有付出创造性劳动前提下所获得的所有其他实施例,都属于本发明保护的范围。The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are only some of the embodiments of the present invention, rather than all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without exerting creative efforts fall within the scope of protection of the present invention.
需要说明,本发明实施例中所有方向性指示(诸如上、下、左、右、前、后……)仅用于解释在某一特定姿态(如附图所示)下各部件之间的相对位置关系、运动情况等,如果该特定姿态发生改变时,则该方向性指示也相应地随之改变。It should be noted that all directional indications (such as up, down, left, right, front, back...) in the embodiment of the present invention are only used to explain the relationship between components in a specific posture (as shown in the drawings). Relative positional relationship, movement conditions, etc., if the specific posture changes, the directional indication will also change accordingly.
另外,在本发明中涉及“第一”、“第二”等的描述仅用于描述目的,而不能理解为指示或暗示其相对重要性或者隐含指明所指示的技术特征的数量。由此,限定有“第一”、“第二”的特征可以明示或者隐含地包括至少一个该特征。另外,全文中出现的“和/或”的含义为,包括三个并列的方案,以“A和/或B”为例,包括A方案,或B方案,或A和B同时满足的方案。另外,各个实施例之间的技术方案可以相互结合,但是必须是以本领域普通技术人员能够实现为基础,当技术方案的结合出现相互矛盾或无法实现时应当认为这种技术方案的结合不存在,也不在本发明要求的保护范围之内。In addition, descriptions involving "first", "second", etc. in the present invention are for descriptive purposes only and cannot be understood as indicating or implying their relative importance or implicitly indicating the number of indicated technical features. Therefore, features defined as "first" and "second" may explicitly or implicitly include at least one of these features. In addition, the meaning of "and/or" appearing in the entire text is to include three parallel plans. Taking "A and/or B" as an example, it includes plan A, or plan B, or a plan that satisfies both A and B at the same time. In addition, the technical solutions in various embodiments can be combined with each other, but it must be based on the realization by those of ordinary skill in the art. When the combination of technical solutions is contradictory or cannot be realized, it should be considered that such a combination of technical solutions does not exist. , nor within the protection scope required by the present invention.
本发明提出一种切割和收集导管,可适用于血管内钙化斑块去除装置或其他硬化物切除装置,此处不限。The present invention proposes a cutting and collecting catheter, which can be used as an intravascular calcified plaque removal device or other sclerosis removal device, and is not limited here.
参照图1至图3,在本发明一实施例中,该切割和收集导管100包括管体10、切割部件20以及收集部件30;管体10设有显露口10a;切割部件20旋转设置于管体10内并位于显露口10a处,切割部件20用于旋转切割血管101内钙化斑块102;收集部件30与管体10一体成型或设于管体10内,收集部件30用于收集切割过程中产生的钙化斑碎块。Referring to Figures 1 to 3, in one embodiment of the present invention, the cutting and collecting catheter 100 includes a tube body 10, a cutting part 20 and a collecting part 30; the tube body 10 is provided with an exposure opening 10a; the cutting part 20 is rotatably arranged on the tube. Inside the body 10 and located at the exposure port 10a, the cutting component 20 is used to rotate and cut the calcified plaque 102 in the blood vessel 101; the collection component 30 is integrally formed with the tube body 10 or is located inside the tube body 10, and the collection component 30 is used to collect the cutting process. Calcified plaque fragments produced in.
本实施例中,管体10可采用医用高分子材料,其可由收集部件30在层压热缩或注塑包胶等工艺过程中形成,也可为单独的部件,具体不限。In this embodiment, the tube body 10 can be made of medical polymer material, which can be formed by the collection component 30 in a process such as lamination and heat shrinkage or injection molding, or can be a separate component, and the details are not limited.
切割部件20可为旋转切刀,此处不限定具体结构。收集部件30可呈管状,特别是镂空管状结构,其可以是单一的部件,通过粘接或熔接等方式装配在管体10内切割部件20的前端,也可以是与管体10一体成型结构,此处不限。The cutting component 20 may be a rotary cutter, and the specific structure is not limited here. The collection component 30 can be in the shape of a tube, especially a hollow tubular structure. It can be a single component that is assembled at the front end of the cutting component 20 in the tube body 10 by bonding or welding, or it can be an integrally formed structure with the tube body 10. No limit here.
可以理解的是,本发明通过设置切割部件20旋转切割血管101内钙化斑块102,同时收集部件30收集切割过程中产生的钙化斑碎块,有效去除了血管101内钙化斑块102,并避免了钙化斑碎块存留在体内血管101中。It can be understood that the present invention effectively removes the calcified plaque 102 in the blood vessel 101 by arranging the cutting part 20 to rotate and cut the calcified plaque 102 in the blood vessel 101, and at the same time the collecting part 30 collects the calcified plaque fragments generated during the cutting process, and avoids Calcified plaque fragments remain in blood vessels 101 in the body.
为提升组装切割部件20的便利性,主要参照图5至图7,在一实施例中,切割部件20可包括刀座21和刀头22,刀座21适于通过传动轴23与驱动组件300驱动连接,刀座21上设有凸柱211,刀头22上对应凸柱211的位置设有与其适配的安装孔22a,凸柱211插设于安装孔22a中并通过焊接或粘接等方式固定。In order to improve the convenience of assembling the cutting component 20 , mainly referring to FIGS. 5 to 7 , in one embodiment, the cutting component 20 may include a cutter base 21 and a cutter head 22 . The cutter base 21 is adapted to be connected to the driving assembly 300 through the transmission shaft 23 Driving connection, the tool base 21 is provided with a protruding post 211, and the cutter head 22 is provided with a matching mounting hole 22a at a position corresponding to the protruding post 211. The protruding post 211 is inserted into the mounting hole 22a and is welded or bonded. The way is fixed.
本实施例中,切割部件20拆分为刀座21和刀头22,可以降低切割部件20的加工难度。其中,刀头22可采用钨钢或者其它硬质合金材料制作而成,以增加刀片硬度。In this embodiment, the cutting component 20 is divided into a knife seat 21 and a knife head 22, which can reduce the processing difficulty of the cutting component 20. Among them, the cutter head 22 can be made of tungsten steel or other hard alloy materials to increase the blade hardness.
优选地,如图7所示,凸柱211可设置为扁平的方柱,对应的安装孔22a可设置为方孔,如此,刀座21与刀头22通过方柱和方孔配合后并可通过焊接或者粘接等方式组装成为一体,可以有效提高在切割部件20旋转过程中刀头22的抗扭强度,刀头22不容易脱落。Preferably, as shown in FIG. 7 , the protruding pillar 211 can be configured as a flat square pillar, and the corresponding mounting hole 22a can be configured as a square hole. In this way, the tool base 21 and the tool head 22 can be assembled through the square pillar and the square hole. Assembling them into one body by welding or bonding can effectively improve the torsional strength of the cutter head 22 during the rotation of the cutting component 20 and prevent the cutter head 22 from falling off easily.
进一步地,结合图3、图5和图6,刀头22的刀刃可向轴心偏转α角,以使刀头22的刀刃与人体血管101壁平行。可选地,刀头22的刀刃可向轴心偏转0~60°。如此,可以使刀头22在工作状态时,理论上刀头22的刀刃与血管101壁和收集囊处于平行状态,可以有效降低血管101切穿的风险。Further, with reference to FIGS. 3 , 5 and 6 , the blade of the cutter head 22 can be deflected by an angle α toward the axis, so that the blade of the cutter head 22 is parallel to the wall of the human blood vessel 101 . Optionally, the cutting edge of the cutter head 22 can be deflected toward the axis by 0° to 60°. In this way, when the cutter head 22 is in the working state, the blade of the cutter head 22 is theoretically parallel to the wall of the blood vessel 101 and the collection bag, which can effectively reduce the risk of the blood vessel 101 cutting through.
为提升切割部件20运行的稳定性,参照图1至图5,在一实施例中,切割部件20还可包括切刀停泊件24和切刀调整件25,切刀停泊件24设于管体10的近端内部并用于在切割部件20工作时供其停靠,切刀调整件25部分插设于管体10的近端内部并用于在切割部件20工作时顶住收集部件30。In order to improve the stability of the operation of the cutting part 20, with reference to Figures 1 to 5, in one embodiment, the cutting part 20 may also include a cutter parking part 24 and a cutter adjustment part 25. The cutter parking part 24 is provided on the pipe body. The proximal end of the tube body 10 is used for stopping the cutting component 20 when it is working. The cutter adjustment member 25 is partially inserted into the proximal end of the tube body 10 and is used to resist the collection component 30 when the cutting component 20 is working.
如图1至图5以及图8所示,在开始切除时,启动血管内钙化斑块去除装置的驱动组件300以将切割部件20从显露口10a中抬起伸出于管体10之外,然后切割部件20旋转切除钙化斑块102,此时切割部件20的内侧停靠在切刀停泊件24上,以维持抬起状态。As shown in Figures 1 to 5 and 8, when starting the resection, the driving assembly 300 of the intravascular calcified plaque removal device is started to lift the cutting component 20 from the exposure port 10a and extend out of the tube body 10, The cutting component 20 then rotates to remove the calcified plaque 102. At this time, the inner side of the cutting component 20 rests on the cutter parking component 24 to maintain the lifted state.
主要参照图5,切割部件20在工作状态下收集部件30的骨架31顶在切刀调整件25上,这样可以增加刀头22在运行过程中的稳定性,减少刀头22或者刀头22周围零件的振动,进一步地降低了血管101切穿的风险。Mainly referring to Figure 5, when the cutting part 20 is in working condition, the skeleton 31 of the collection part 30 is pressed against the cutter adjustment member 25, which can increase the stability of the cutter head 22 during operation and reduce the number of cuts around the cutter head 22 or the cutter head 22. The vibration of the parts further reduces the risk of the blood vessel 101 cutting through.
参照图1及图2,在一实施例中,收集部件30可包括骨架31、第一导丝腔体32及第一显影件33,骨架31、第一导丝腔体32与第一显影件33层压热缩或注塑包胶等工艺形成收集管主体310,骨架31呈镂空状,第一导丝腔体32形成有供导丝通过的第一导丝腔道,第一显影件33设于第一导丝腔体32内,第一显影件33用于在影像设备探测下显影,以在切割和收集导管100进入人体后标记收集部件30所处位置。Referring to FIGS. 1 and 2 , in one embodiment, the collecting component 30 may include a frame 31 , a first guidewire cavity 32 and a first developing member 33 . The frame 31 , the first guidewire cavity 32 and the first developing member 33 33 The main body 310 of the collection tube is formed by lamination, heat shrinkage or injection molding. The skeleton 31 is hollow. The first guide wire cavity 32 forms a first guide wire cavity for the guide wire to pass through. The first developing member 33 is provided with In the first guidewire cavity 32, the first developing member 33 is used to develop under detection by imaging equipment to mark the position of the collection component 30 after the cutting and collection catheter 100 enters the human body.
本实施例中,骨架31、第一导丝腔体32与第一显影件33通过高分子材料层压热缩或者包胶注塑等方式固定在一起并形成收集管主体310。其中,骨架31可通过激光切割或者其它工艺制造而成的镂空不锈钢管或者镍钛管等,目的是降低收集部件30的刚性,增加其柔韧性,便于通过血管101,进一步地降低血管101损伤。In this embodiment, the skeleton 31 , the first guide wire cavity 32 and the first developing member 33 are fixed together through polymer material lamination and heat shrinkage or plastic injection molding to form the collection tube main body 310 . Among them, the skeleton 31 can be a hollow stainless steel tube or a nickel-titanium tube made by laser cutting or other processes. The purpose is to reduce the rigidity of the collection component 30 and increase its flexibility to facilitate passage of the blood vessel 101 and further reduce damage to the blood vessel 101.
主要参照图4,在一实施例中,收集部件30设置有弯型段301,弯型段301用于使切割部件20贴近钙化斑块102所处的血管101壁,以提升去除钙化斑块102的效果。Referring mainly to Figure 4, in one embodiment, the collection component 30 is provided with a curved section 301. The curved section 301 is used to bring the cutting component 20 close to the wall of the blood vessel 101 where the calcified plaque 102 is located, so as to lift and remove the calcified plaque 102. Effect.
本实施例中,弯型段301可以设置在显露口10a的背面,也可设置在收集部件30的其它位置,比如镂空的骨架31处,此处不限。In this embodiment, the curved section 301 can be disposed on the back side of the exposure opening 10a, or can be disposed at other locations of the collection component 30, such as the hollow frame 31, which is not limited thereto.
为方便将导管插入至血管101中,并降低对血管101的损伤,参照图1及图2,在一实施例中,切割和收集导管100还可包括设置于管体10远端的尖头组件40,尖头组件40整体呈锥形。In order to facilitate the insertion of the catheter into the blood vessel 101 and reduce damage to the blood vessel 101, referring to Figures 1 and 2, in one embodiment, the cutting and collection catheter 100 may also include a tip assembly disposed at the distal end of the tube body 10 40. The pointed assembly 40 is tapered as a whole.
本实施例中,尖头组件40可包括支撑件41、连接件42、第二导丝腔体43及第二显影件44,支撑件41、连接件42、第二导丝腔体43与第二显影件44层压热缩或注塑包胶等工艺形成尖头主体410,支撑件41与收集部件30连接,连接件42嵌设于尖头主体410中,第二导丝腔体43设有供导丝通过的第二导丝腔道,第二显影件44设于第二导丝腔体43内,第二显影件44用于在影像设备探测下显影,以在切割和收集导管100进入人体后标记尖头组件40所处位置。In this embodiment, the tip assembly 40 may include a support member 41, a connecting member 42, a second guide wire cavity 43 and a second developing member 44. The support member 41, the connecting member 42, the second guide wire cavity 43 and the second developing member 44 are The two developing parts 44 are laminated and heat-shrunk or injection molded to form the tip body 410. The support member 41 is connected to the collection part 30. The connecting piece 42 is embedded in the tip body 410. The second guide wire cavity 43 is provided with The second guide wire lumen for the guide wire to pass through, the second developing member 44 is provided in the second guide wire cavity 43, and the second developing member 44 is used to develop under detection by the imaging device to ensure that the cutting and collecting catheter 100 enters the second guide wire lumen. The position of the tip assembly 40 is marked behind the human body.
本实施例中,支撑件41、连接件42、第二导丝腔体43与第二显影件44通过高分子材料层压热缩或者包胶注塑等工艺固定在一起并形成尖头主体410。其中,连接件42可以增加层压热缩或者包胶注塑后高分子材料与支撑件41的连接强度,连接件42可为弹簧或者异形表面凹凸不平的零件,以增加高分子材料与支撑件41的连接强度。支撑件41与收集部件30连接可通过焊接、机械卡槽、粘接、层压热缩等工艺进行连接。In this embodiment, the support member 41 , the connecting member 42 , the second guide wire cavity 43 and the second developing member 44 are fixed together through processes such as polymer material lamination and heat shrinkage or overcoating injection molding to form the tip body 410 . Among them, the connector 42 can increase the connection strength between the polymer material and the support 41 after lamination, heat shrinkage or overmolding. The connector 42 can be a spring or a part with uneven surfaces to increase the connection strength between the polymer material and the support 41 . connection strength. The support member 41 and the collection member 30 can be connected through processes such as welding, mechanical slotting, bonding, lamination and heat shrinkage.
本发明还提出一种血管内钙化斑块去除装置,参照图8,该血管内钙化斑块去除装置包括切割和收集导管100,该切割和收集导管100的具体结构参照上述实施例,由于本发明提出的血管内钙化斑块去除装置包括上述切割和收集导管100的所有实施例的所有方案,因此,至少具有与上述切割和收集导管100相同的技术效果,此处不一一阐述。The present invention also proposes an intravascular calcified plaque removal device. Refer to Figure 8. The intravascular calcified plaque removal device includes a cutting and collecting catheter 100. The specific structure of the cutting and collecting catheter 100 refers to the above embodiment. Since the present invention The proposed intravascular calcified plaque removal device includes all solutions of all embodiments of the above-mentioned cutting and collecting catheter 100. Therefore, it has at least the same technical effect as the above-mentioned cutting and collecting catheter 100, which will not be described one by one here.
主要参照图3及图8,在本发明一实施例中,该血管内钙化斑块去除装置包括切割和收集导管100、输送导管200以及驱动组件300;输送导管200的近端固定在驱动组件300上;切割和收集导管100固定在输送导管200的远端上并与驱动组件300驱动连接,驱动组件300用于驱动切割和收集导管100的切割部件20旋转以切割血管101内钙化斑块102。Referring mainly to Figures 3 and 8, in one embodiment of the present invention, the intravascular calcified plaque removal device includes a cutting and collection catheter 100, a delivery catheter 200 and a driving assembly 300; the proximal end of the delivery catheter 200 is fixed on the driving assembly 300 Upper; the cutting and collecting catheter 100 is fixed on the distal end of the delivery catheter 200 and is drivingly connected with the driving assembly 300. The driving assembly 300 is used to drive the cutting component 20 of the cutting and collecting catheter 100 to rotate to cut the calcified plaque 102 in the blood vessel 101.
本实施例中,驱动组件300可包括电机、电池、电路、开关、外壳等部件,电池为电机提供动力,结合图2及图8,将电机的输出轴与连接切割部件20的传动轴23固定连接在一起,从而将电机的转动通过传动轴23传递至切割部件20,从而实现切割部件20的旋转。其中,传动轴23的扭力传输比可为1∶1,此处不限。In this embodiment, the driving assembly 300 may include a motor, a battery, a circuit, a switch, a housing and other components. The battery provides power for the motor. With reference to Figures 2 and 8, the output shaft of the motor is fixed to the transmission shaft 23 connected to the cutting component 20. are connected together, thereby transmitting the rotation of the motor to the cutting component 20 through the transmission shaft 23, thereby realizing the rotation of the cutting component 20. Among them, the torque transmission ratio of the transmission shaft 23 can be 1:1, which is not limited here.
另外,处于远端的切割和收集导管100和输送导管200可做亲水涂层处理,以提高导管在血管101内部的通过性。In addition, the cutting and collecting catheter 100 and the delivery catheter 200 at the distal end can be treated with hydrophilic coating to improve the passage of the catheter inside the blood vessel 101 .
参照图9,在一实施例中,输送导管200可包括螺旋扭力管210、防漏膜220及金属编织网230,螺旋扭力管210、防漏膜220与金属编织网230通过高分子材料层压热缩或注塑包胶等工艺固定在一起并形成导管主体240,其中螺旋扭力管210、防漏膜220与金属编织网230由内向外依次分布。Referring to FIG. 9 , in one embodiment, the delivery catheter 200 may include a spiral torque tube 210 , a leak-proof membrane 220 and a metal braid 230 . The spiral torque tube 210 , the leak-proof membrane 220 and the metal braid 230 are laminated by polymer materials. They are fixed together by processes such as heat shrinking or injection molding to form the main body 240 of the conduit, in which the spiral torque tube 210, the leak-proof membrane 220 and the metal braid 230 are sequentially distributed from the inside to the outside.
其中,防漏膜220可采用PTFE等材质,此处不限。Among them, the anti-leakage membrane 220 can be made of PTFE or other materials, which is not limited here.
如图3所示,输送导管200设置有固定弯管段201,固定弯管段201适于贴靠于血管101壁上并用于为切割部件20提供支撑力,以使其贴近钙化斑块102所处的血管101壁。即,输送导管200的一段可设置为固定弯型,从而为切割部件20工作过程中提供良好的贴壁能力,切割部件20更容易贴在钙化斑块102上,达到良好的切割效果。较优地,固定弯管段201的弯曲度可为30°~90°,其可为固定形态的柔性材质制成的弯管。As shown in FIG. 3 , the delivery catheter 200 is provided with a fixed elbow section 201 . The fixed elbow section 201 is adapted to abut against the wall of the blood vessel 101 and is used to provide supporting force for the cutting component 20 so that it can be close to the calcified plaque 102 . The wall of blood vessel 101 at. That is, a section of the delivery catheter 200 can be set in a fixed curved shape, thereby providing the cutting component 20 with good wall-adhering ability during operation, and the cutting component 20 can more easily adhere to the calcified plaque 102 to achieve a good cutting effect. Preferably, the curvature of the fixed elbow section 201 can be 30° to 90°, and it can be an elbow made of a fixed-shaped flexible material.
参照图5,在一实施例中,驱动组件300还可用于控制切割部件20的刀刃在切割钙化斑时抬起预设高度h,预设高度h适于小于血管101壁厚。可选地,预设高度h可为0~1mm。Referring to FIG. 5 , in one embodiment, the driving assembly 300 can also be used to control the blade of the cutting component 20 to lift a preset height h when cutting calcified plaques, and the preset height h is suitable to be smaller than the wall thickness of the blood vessel 101 . Optionally, the preset height h can be 0~1mm.
如图1所示,该血管内钙化斑块去除装置非工作状态,此时切割部件20在收集部件30的内部,驱动组件300的电源开关为关闭状态。在施术时,该装置的前端的切割和收集导管100经过人体指定血管101介入,通过血管101系统,将导管推送到病人的靶病变血管101位置,如图3所示,然后再启动驱动组件300的电源开关,切割部件20停靠在切刀停泊件24上,切割部件20抬起并开始旋转,此时通过向前推送导管使切割部件20经过血管101靶病变部位,去除血管101内钙化斑块102并收集在收集部件30内,完成病变的治疗。As shown in FIG. 1 , the intravascular calcified plaque removal device is in an inoperative state. At this time, the cutting component 20 is inside the collection component 30 and the power switch of the driving component 300 is in a closed state. During the operation, the cutting and collecting catheter 100 at the front end of the device is inserted through the designated blood vessel 101 of the human body, and the catheter is pushed to the patient's target diseased blood vessel 101 through the blood vessel 101 system, as shown in Figure 3, and then the driving assembly is started. 300 power switch, the cutting part 20 is docked on the cutter parking part 24, the cutting part 20 is lifted up and starts to rotate. At this time, the cutting part 20 is pushed forward to pass the target lesion of the blood vessel 101, and the calcified plaque in the blood vessel 101 is removed. Block 102 and collect it in the collection part 30 to complete the treatment of the lesion.
更进一步地,在切割部件20处于切割状态时,如图5所示,切割部件20的刀头22抬起一定预设高度h,使刀头22接触钙化斑块102时,刀头22能够嵌入至钙化斑块102。在实际应用中,通过设计一定的预设高度h,可以达到切割一定厚度的钙化斑块102的效果。Furthermore, when the cutting part 20 is in the cutting state, as shown in FIG. 5 , the cutter head 22 of the cutting part 20 is raised to a certain preset height h, so that when the cutter head 22 contacts the calcified plaque 102 , the cutter head 22 can be embedded. to calcified plaque 102. In practical applications, by designing a certain preset height h, the effect of cutting calcified plaque 102 of a certain thickness can be achieved.
本发明有效防止了血管101切穿的风险。一方面通过调节预设高度h,使预设高度h的值小于血管101壁厚;另一方面该去除装置通过调节刀头22的刀刃上述角度α的方式,可以使刀头22在工作状态时,理论上刀刃与血管101壁和收集囊处于平行状态,在工作状态下刀头22的刀刃水平抬高预设高度h,避免了刀刃与血管101的内壁接触。The present invention effectively prevents the risk of blood vessel 101 cutting through. On the one hand, by adjusting the preset height h, the value of the preset height h is smaller than the wall thickness of the blood vessel 101; on the other hand, the removal device can adjust the angle α of the blade of the cutter head 22 to make the cutter head 22 in the working state. , in theory, the blade is in a parallel state with the wall of the blood vessel 101 and the collection bag. In the working state, the blade of the blade 22 is horizontally raised to a preset height h, which avoids contact between the blade and the inner wall of the blood vessel 101.
以上所述仅为本发明的可选实施例,并非因此限制本发明的专利范围,凡是在本发明的发明构思下,利用本发明说明书及附图内容所作的等效结构变换,或直接/间接运用在其他相关的技术领域均包括在本发明的专利保护范围内。The above are only optional embodiments of the present invention, and are not intended to limit the patent scope of the present invention. Under the inventive concept of the present invention, equivalent structural transformations can be made using the contents of the description and drawings of the present invention, or directly/indirectly. Application in other related technical fields is included in the scope of patent protection of the present invention.
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