技术领域Technical Field
本发明涉及医疗器械技术领域，尤其涉及一种导引抽吸导管及具有该导管的导管系统。The present invention relates to the technical field of medical devices, and in particular to a guiding suction catheter and a catheter system having the catheter.
背景技术Background Art
经皮冠状动脉介入治疗(percutaneous transluminal coronary intervention，PCI)是指采用经皮穿刺技术送入球囊导管或其他相关器械，解除冠状动脉狭窄或梗阻，重建冠状动脉血流的技术。Percutaneous transluminal coronary intervention (PCI) refers to the technology of using percutaneous puncture technology to insert a balloon catheter or other related devices to relieve coronary artery stenosis or obstruction and restore coronary blood flow.
随着医学的不断发展，医学介入手术也得到了极大的发展。延伸导管在冠心CTO病变手术介入治疗过程中，以导引导管做指引，能够更深入的治疗侧枝以及远离主动脉的病变。在小血管介入治疗的过程中，一般情况下，会将导引导管输送至靠近小血管的较大血管位置处，然后将导丝穿过导引导管并输送至小血管的血栓处，延伸导管套设在导丝上并沿着导丝到达靶区，然后进行抽吸。但该方式存在以下其问题：针对远端小血管，需要使用延伸导管，由于延伸导管的管腔内存在导丝，导丝占据延伸导管的管腔的面积，且导丝不是紧靠导管壁，造成抽吸通路不顺畅，有效抽吸面积较小，影响血栓的抽吸效果。With the continuous development of medicine, medical interventional surgery has also been greatly developed. During the surgical interventional treatment of coronary CTO lesions, the extension catheter is guided by the guide catheter, which can more deeply treat the side branches and lesions far away from the aorta. In the process of small blood vessel interventional treatment, under normal circumstances, the guide catheter will be delivered to the position of the larger blood vessel close to the small blood vessel, and then the guide wire will be passed through the guide catheter and delivered to the thrombus of the small blood vessel. The extension catheter is placed on the guide wire and reaches the target area along the guide wire, and then suction is performed. However, this method has the following problems: for distal small blood vessels, an extension catheter is required. Since there is a guide wire in the lumen of the extension catheter, the guide wire occupies the area of the lumen of the extension catheter, and the guide wire is not close to the catheter wall, resulting in an unsmooth suction passage and a small effective suction area, which affects the suction effect of the thrombus.
因此，有必要提供一种抽吸通路顺畅、可避免导丝对管腔的有效抽吸面积造成影响的导引抽吸导管，以及提供一种具有该导引抽吸导管的导管系统。Therefore, it is necessary to provide a guiding suction catheter with a smooth suction passageway that can prevent the guide wire from affecting the effective suction area of the lumen, and to provide a catheter system having the guiding suction catheter.
发明内容Summary of the invention
本发明的第一目的在于提供一种抽吸通路顺畅、可避免导丝对管腔的有效抽吸面积造成影响的导引抽吸导管。The first object of the present invention is to provide a guide suction catheter with a smooth suction passageway and capable of preventing the guide wire from affecting the effective suction area of the lumen.
本发明的第二目的在于提供一种导管系统，该导管系统具有导引抽吸导管，借由导引抽吸导管来保证抽吸通路顺畅，并避免导丝对管腔的有效抽吸面积造成影响。The second object of the present invention is to provide a catheter system having a guide suction catheter, which ensures a smooth suction passage and prevents the guide wire from affecting the effective suction area of the lumen.
为实现上述第一目的，本发明提供了一种导引抽吸导管，包括导管主体、递送件、递送手柄、锚定球囊及导丝管，所述导管主体内设有用于输送医疗器械的延长通道，所述导管主体的近端设有与所述延长通道连通的导入口；所述递送件的远端与所述导管主体的近端连接，所述递送件的内部设有充盈通道；所述递送手柄的远端与所述递送件的近端连接，所述递送手柄的内腔与所述充盈通道连通；所述锚定球囊套设于所述导管主体上并位于靠近所述导管主体近端的位置处，所述锚定球囊的内腔与所述充盈通道连通；所述导丝管沿所述导管主体的导管方向与所述导管主体并列连接，且所述导丝管的近端位于所述锚定球囊的远端一侧，所述导丝管的远端延伸到所述导管主体的远端，所述导丝管内设有供导丝穿过的导丝腔。To achieve the above-mentioned first purpose, the present invention provides a guiding suction catheter, comprising a catheter body, a delivery member, a delivery handle, an anchoring balloon and a guidewire tube, wherein the catheter body is provided with an extension channel for delivering medical devices, and the proximal end of the catheter body is provided with an introduction port connected to the extension channel; the distal end of the delivery member is connected to the proximal end of the catheter body, and a filling channel is provided inside the delivery member; the distal end of the delivery handle is connected to the proximal end of the delivery member, and the inner cavity of the delivery handle is connected to the filling channel; the anchoring balloon is sleeved on the catheter body and located near the proximal end of the catheter body, and the inner cavity of the anchoring balloon is connected to the filling channel; the guidewire tube is connected in parallel with the catheter body along the catheter direction of the catheter body, and the proximal end of the guidewire tube is located on the distal side of the anchoring balloon, the distal end of the guidewire tube extends to the distal end of the catheter body, and the guidewire tube is provided with a guidewire cavity for the guidewire to pass through.
与现有技术相比，本发明的导引抽吸导管通过在导管主体的导管方向并列地连接有导丝管，使得导丝可穿过该导丝管的导丝腔而不占据导管主体的延长通道的面积，使得通过导管主体的延长通道进行抽吸的抽吸通路顺畅，有效抽吸面积相对较大，可避免导丝对管腔的有效抽吸面积造成影响，并提高抽吸效果，同时，穿过导丝腔的导丝也可对导管主体进行引导锚定，保证导引抽吸导管可准确地输送至靶区。Compared with the prior art, the guide suction catheter of the present invention is connected to a guide wire tube in parallel in the catheter direction of the catheter body, so that the guide wire can pass through the guide wire cavity of the guide wire tube without occupying the area of the extension channel of the catheter body, so that the suction passage for suction through the extension channel of the catheter body is smooth, and the effective suction area is relatively large, which can avoid the guide wire from affecting the effective suction area of the lumen and improve the suction effect. At the same time, the guide wire passing through the guide wire cavity can also guide and anchor the catheter body, ensuring that the guide suction catheter can be accurately delivered to the target area.
较佳地，所述导丝管设置于所述导管主体的外壁上。Preferably, the guide wire tube is arranged on the outer wall of the catheter body.
较佳地，所述导管主体的远端为斜切抽吸口。Preferably, the distal end of the catheter body is a beveled suction port.
较佳地，所述导管主体包括由内向外依次设置的内层、中间加强层和外层。Preferably, the catheter body includes an inner layer, a middle reinforcement layer and an outer layer which are sequentially arranged from inside to outside.
较佳地，所述外层的软硬度由所述导管主体的近端往远端依次降低。Preferably, the hardness of the outer layer decreases from the proximal end to the distal end of the catheter body.
较佳地，所述递送件的远端固定于所述导管主体的管壁内，所述递送件靠近所述导管主体近端的位置处设有通孔，所述通孔连通于所述充盈通道与所述锚定球囊的内腔之间。Preferably, the distal end of the delivery member is fixed in the tube wall of the catheter body, and a through hole is provided at a position of the delivery member close to the proximal end of the catheter body, and the through hole is connected between the filling channel and the inner cavity of the anchoring balloon.
较佳地，所述递送件的内部呈空心结构，所述充盈通道形成于所述空心结构内，且所述递送件的远端延伸至对应所述锚定球囊的位置处。Preferably, the interior of the delivery member is a hollow structure, the filling channel is formed in the hollow structure, and the distal end of the delivery member extends to a position corresponding to the anchoring balloon.
较佳地，所述导管主体的导入口呈斜口结构。Preferably, the introduction port of the catheter body is an oblique port structure.
为实现上述第二目的，本发明提供了一种导管系统，包括指引导管、导丝及上述的导引抽吸导管，所述指引导管内设有指引通道，当所述锚定球囊未充盈时，所述导引抽吸导管在所述指引通道内滑动，所述导丝可活动地穿过所述指引通道和所述导丝腔；当所述锚定球囊充盈时，所述锚定球囊扩张后抵接于所述指引通道的内壁和所述导丝上，所述延长通道与所述指引通道连通。To achieve the above-mentioned second purpose, the present invention provides a catheter system, including a guiding catheter, a guide wire and the above-mentioned guiding suction catheter, wherein a guiding channel is provided in the guiding catheter, and when the anchoring balloon is not filled, the guiding suction catheter slides in the guiding channel, and the guide wire can movably pass through the guiding channel and the guide wire cavity; when the anchoring balloon is filled, the anchoring balloon expands and abuts against the inner wall of the guiding channel and the guide wire, and the extension channel is connected to the guiding channel.
与现有技术相比，本发明的导管系统具有导引抽吸导管，该导引抽吸导管通过在导管主体的导管方向并列地连接有导丝管，使得导丝可穿过该导丝管的导丝腔而不占据导管主体的延长通道的面积，使得通过指引通道和延长通道进行抽吸的抽吸通路顺畅，有效抽吸面积相对较大，可避免导丝对管腔的有效抽吸面积造成影响，并提高抽吸效果，同时，穿过导丝腔的导丝也可对导管主体进行引导锚定，保证导引抽吸导管可准确地输送至靶区。Compared with the prior art, the catheter system of the present invention has a guiding suction catheter, which is connected to a guide wire tube in parallel in the catheter direction of the catheter body, so that the guide wire can pass through the guide wire cavity of the guide wire tube without occupying the area of the extension channel of the catheter body, so that the suction path for suction through the guiding channel and the extension channel is smooth, and the effective suction area is relatively large, which can avoid the influence of the guide wire on the effective suction area of the lumen and improve the suction effect. At the same time, the guide wire passing through the guide wire cavity can also guide and anchor the catheter body, ensuring that the guiding suction catheter can be accurately delivered to the target area.
较佳地，所述导引抽吸导管穿插于所述指引通道内，且所述导管主体的远端从所述指引通道的远端穿出来，所述导管主体的近端位于所述指引通道内，所述递送件的近端位于所述指引通道的近端外侧。Preferably, the guide suction catheter is inserted into the guide channel, and the distal end of the catheter body passes through the distal end of the guide channel, the proximal end of the catheter body is located in the guide channel, and the proximal end of the delivery member is located outside the proximal end of the guide channel.
附图说明BRIEF DESCRIPTION OF THE DRAWINGS
图1是本发明的导引抽吸导管的结构示意图。FIG. 1 is a schematic structural diagram of a guide suction catheter of the present invention.
图2是图1中沿A-A方向的剖视示意图。Fig. 2 is a schematic cross-sectional view along the A-A direction in Fig. 1.
图3是图1中沿A-A方向的另一实施方式的剖视示意图。Fig. 3 is a schematic cross-sectional view of another embodiment along the A-A direction in Fig. 1 .
图4是图3中C处的放大图。FIG. 4 is an enlarged view of point C in FIG. 3 .
图5是图1中沿B-B方向的剖视示意图。Fig. 5 is a schematic cross-sectional view along the B-B direction in Fig. 1 .
图6是图1中沿B-B方向的第二实施方式的剖视示意图。Fig. 6 is a schematic cross-sectional view of the second embodiment along the B-B direction in Fig. 1 .
图7是图1中沿B-B方向的第三实施方式的剖视示意图。Fig. 7 is a schematic cross-sectional view of the third embodiment along the B-B direction in Fig. 1 .
图8是图1中沿B-B方向的第四实施方式的剖视示意图。Fig. 8 is a schematic cross-sectional view of the fourth embodiment along the B-B direction in Fig. 1 .
图9是图1中沿B-B方向的第五实施方式的剖视示意图。Fig. 9 is a schematic cross-sectional view of the fifth embodiment along the B-B direction in Fig. 1 .
图10本发明的导引抽吸导管沿其导管方向的剖视示意图。FIG. 10 is a schematic cross-sectional view of the guide suction catheter of the present invention along its catheter direction.
图11是本发明的第一实施方式的导管系统的在抽吸工作时的结构图。FIG. 11 is a structural diagram of the catheter system according to the first embodiment of the present invention during suction operation.
图12是本发明的导管系统的局部半剖示意图。FIG. 12 is a partial half-section schematic diagram of the catheter system of the present invention.
图13是本发明的另一实施方式的导引抽吸导管的远端结构示意图。FIG. 13 is a schematic diagram of the distal structure of a guide suction catheter according to another embodiment of the present invention.
具体实施方式DETAILED DESCRIPTION
为了详细说明本发明的技术内容、构造特征，以下结合实施方式并配合附图作进一步说明。其中，需要说明的是，以上描述及以下描述中的“近端”通常是指医疗设备在正常操作过程中靠近操作者的一端，“远端”通常是指医疗设备在正常操作过程中首先进入患者体内的一端。In order to explain the technical content and structural features of the present invention in detail, the following is further explained in combination with the embodiments and the accompanying drawings. It should be noted that the "proximal end" in the above description and the following description usually refers to the end of the medical device close to the operator during normal operation, and the "distal end" usually refers to the end of the medical device that first enters the patient's body during normal operation.
请参阅图1至图13，本发明的导管系统200包括指引导管201、导丝202及导引抽吸导管100。其中，导引抽吸导管100包括导管主体1、递送件2、递送手柄3、锚定球囊4及导丝管5，导管主体1内设有用于输送医疗器械的延长通道11，导管主体1的近端设有与延长通道11连通的导入口12；递送件2的远端与导管主体1的近端连接，递送件2的内部设有充盈通道21；递送手柄3的远端与递送件2的近端连接，递送手柄3的内腔与充盈通道21连通；锚定球囊4套设于导管主体1上并位于靠近导管主体1近端的位置处，锚定球囊4的内腔与充盈通道21连通；导丝管5沿导管主体1的导管方向与导管主体1的并列连接，且导丝管5的近端位于锚定球囊4的远端一侧，导丝管5的远端延伸到导管主体1的远端，导丝管5内设有供导丝202穿过的导丝腔51。指引导管201内设有指引通道201a，当锚定球囊4未充盈时，导引抽吸导管100在指引通道201a内滑动，导丝202可活动地穿过指引通道201a和导丝腔51；当锚定球囊4充盈时，锚定球囊4扩张后抵接于指引通道201a的内壁和导丝202上，延长通道11与指引通道201a连通。Please refer to FIGS. 1 to 13 , the catheter system 200 of the present invention includes a guiding catheter 201 , a guide wire 202 , and a guiding suction catheter 100 . Among them, the guiding suction catheter 100 includes a catheter body 1, a delivery member 2, a delivery handle 3, an anchoring balloon 4 and a guidewire tube 5. The catheter body 1 is provided with an extension channel 11 for conveying medical devices, and the proximal end of the catheter body 1 is provided with an introduction port 12 connected to the extension channel 11; the distal end of the delivery member 2 is connected to the proximal end of the catheter body 1, and a filling channel 21 is provided inside the delivery member 2; the distal end of the delivery handle 3 is connected to the proximal end of the delivery member 2, and the inner cavity of the delivery handle 3 is connected to the filling channel 21; the anchoring balloon 4 is sleeved on the catheter body 1 and is located near the proximal end of the catheter body 1, and the inner cavity of the anchoring balloon 4 is connected to the filling channel 21; the guidewire tube 5 is connected in parallel with the catheter body 1 along the catheter direction of the catheter body 1, and the proximal end of the guidewire tube 5 is located on the distal side of the anchoring balloon 4, and the distal end of the guidewire tube 5 extends to the distal end of the catheter body 1, and a guidewire cavity 51 for the guidewire 202 to pass through is provided in the guidewire tube 5. A guiding channel 201a is provided in the guiding catheter 201. When the anchoring balloon 4 is not filled, the guiding suction catheter 100 slides in the guiding channel 201a, and the guide wire 202 can movably pass through the guiding channel 201a and the guide wire cavity 51; when the anchoring balloon 4 is filled, the anchoring balloon 4 expands and abuts against the inner wall of the guiding channel 201a and the guide wire 202, and the extension channel 11 is connected to the guiding channel 201a.
具体地，导引抽吸导管100穿插于指引通道201a内，且导管主体1的远端从指引通道201a的远端穿出来，导管主体1的近端位于指引通道201a内，递送件2的近端位于指引通道201a的近端外侧，导入口12将延长通道11与指引通道201a连通。Specifically, the guide suction catheter 100 is inserted into the guiding channel 201a, and the distal end of the catheter body 1 comes out from the distal end of the guiding channel 201a, the proximal end of the catheter body 1 is located in the guiding channel 201a, the proximal end of the delivery member 2 is located outside the proximal end of the guiding channel 201a, and the introduction port 12 connects the extension channel 11 with the guiding channel 201a.
请参阅图5及图6，在一实施例中，导丝管5设置于导管主体1的外壁上，但不以此为限。Please refer to FIG. 5 and FIG. 6 . In one embodiment, the guide wire tube 5 is disposed on the outer wall of the catheter body 1 , but the present invention is not limited thereto.
请参阅图1及图13，在一实施例中，导管主体1的远端为斜切抽吸口。通过将导管主体1的远端设置为斜切抽吸口，从而增加导管主体1的远端与血栓300的接触面积，提升血栓300抓捕能力，以及提升抽吸效率。斜切抽吸口与导管主体1的轴向夹角可以为0-90度，但不限于此。Referring to FIG. 1 and FIG. 13 , in one embodiment, the distal end of the catheter body 1 is an oblique suction port. By setting the distal end of the catheter body 1 as an oblique suction port, the contact area between the distal end of the catheter body 1 and the thrombus 300 is increased, the thrombus 300 capture capability is improved, and the suction efficiency is improved. The axial angle between the oblique suction port and the catheter body 1 can be 0-90 degrees, but is not limited thereto.
请参阅图3，在一实施例中，导管主体1包括由内向外依次设置的内层13、中间加强层14和外层15。导管主体1为三层复合结构，能提供强支撑性、耐压性和抗折性。3, in one embodiment, the catheter body 1 includes an inner layer 13, an intermediate reinforcement layer 14 and an outer layer 15 arranged in sequence from the inside to the outside. The catheter body 1 is a three-layer composite structure, which can provide strong support, pressure resistance and folding resistance.
在一实施例中，内层13材质为聚四氟乙烯或线性低密度聚乙烯，从而为其他器械通过位于内层13内的延长通道11提供较低的摩擦；中间加强层14为不锈钢编织网层或弹簧层，使得导管主体1具备强耐负压能力，以及强支撑性，以提高导管主体1的抗折性和扭控性；外层15材质为聚醚前端聚酰胺、尼龙和聚氨酯弹性体中的一种或多种混合物，外表面具有更光滑的外观和手感，充分保护血管，避免产生血栓300、夹层等。In one embodiment, the inner layer 13 is made of polytetrafluoroethylene or linear low-density polyethylene, thereby providing lower friction for other instruments to pass through the extended channel 11 located in the inner layer 13; the middle reinforcement layer 14 is a stainless steel braided mesh layer or a spring layer, so that the catheter body 1 has strong negative pressure resistance and strong support, so as to improve the folding resistance and torsion control of the catheter body 1; the outer layer 15 is made of one or more mixtures of polyether front-end polyamide, nylon and polyurethane elastomer, and the outer surface has a smoother appearance and feel, which fully protects the blood vessels and avoids the formation of thrombus 300, dissection, etc.
在一实施例中，外层15的软硬度由导管主体1的近端往远端依次降低。使得导管主体1不显突兀，更好地满足导管主体1在人体血管内推送的需求，既能让医生更精准，更方便的操作，又能减少病人在手术过程中的痛苦。进一步地，外层15还涂覆有亲水层，导管主体1头端柔软无创。此设计确保导管主体1具有良好的支撑性、操控性和润滑性。In one embodiment, the hardness of the outer layer 15 decreases from the proximal end to the distal end of the catheter body 1. This makes the catheter body 1 less obtrusive and better meets the requirements of pushing the catheter body 1 into human blood vessels, which can not only allow doctors to operate more accurately and conveniently, but also reduce the pain of patients during the operation. Furthermore, the outer layer 15 is also coated with a hydrophilic layer, and the tip of the catheter body 1 is soft and non-invasive. This design ensures that the catheter body 1 has good support, controllability and lubricity.
如图5及图6，在一实施例中，导管主体1和导丝管5是分体设置的，导管主体1与导丝管5进行粘接、熔接、通过连接件连接在一起。可以理解的是，只要使得导丝腔51和延长通道11分割设置，即落入本申请范围。请参阅图7至图9，在其他实施例中，导管主体1和导丝管5也可以是是一体设置的，使得导丝腔51和延长通道11分割设置，导丝腔51优先设置于导管主体1内，延长通道11的截面形状可以进行多种变形，例如图7至图9所示，但不限于此。As shown in Figures 5 and 6, in one embodiment, the catheter body 1 and the guide wire tube 5 are separately arranged, and the catheter body 1 and the guide wire tube 5 are bonded, welded, and connected together by a connector. It is understandable that as long as the guide wire cavity 51 and the extension channel 11 are divided and arranged, it falls within the scope of this application. Please refer to Figures 7 to 9. In other embodiments, the catheter body 1 and the guide wire tube 5 can also be integrally arranged, so that the guide wire cavity 51 and the extension channel 11 are divided and arranged, and the guide wire cavity 51 is preferentially arranged in the catheter body 1, and the cross-sectional shape of the extension channel 11 can be multiple deformations, such as shown in Figures 7 to 9, but is not limited thereto.
请参阅图1至图4、图10，在一实施例中，递送件2的远端固定于导管主体1的管壁内，递送件2靠近导管主体1近端的位置处设有通孔22，通孔22连通于充盈通道21与锚定球囊4的内腔之间。递送手柄3的内腔、递送件2的充盈通道21及锚定球囊4的内腔相互连通并形成单腔通道，医生可在递送手柄3处连接注射流体等介质，流体等介质可以通过递送手柄3的内腔、递送件2的充盈通道21及通孔22进入锚定球囊4，从而对锚定球囊4进行充压，使得锚定球囊4迅速锚定在指引导管201的指引通道201a内，并进行封堵，将导引抽吸导管100与指引导管201密封性连接起来，后续抽吸血栓或斑块时，此处不会降低抽吸压力，也能防止导引抽吸导管100移动。锚定球囊4充盈时可以锚定导丝202，在医生操作过程中，防止导丝202前后移动，避免因为导引抽吸导管100或导丝202的移动可能造成血管的损伤。还有，由于递送件2的远端固定于导管主体1的管壁内，故而递送件2可隐藏在导管主体1的材料中间处，使得递送件2不对血管造成损伤。具体地，递送件2上设有若干个通孔22，通孔22分布于球囊中间位置。Please refer to Figures 1 to 4 and 10. In one embodiment, the distal end of the delivery member 2 is fixed in the wall of the catheter body 1. The delivery member 2 is provided with a through hole 22 near the proximal end of the catheter body 1. The through hole 22 is connected between the filling channel 21 and the inner cavity of the anchoring balloon 4. The inner cavity of the delivery handle 3, the filling channel 21 of the delivery member 2 and the inner cavity of the anchoring balloon 4 are connected to each other and form a single cavity channel. The doctor can connect the delivery handle 3 to inject fluid and other media. The fluid and other media can enter the anchoring balloon 4 through the inner cavity of the delivery handle 3, the filling channel 21 of the delivery member 2 and the through hole 22, thereby pressurizing the anchoring balloon 4, so that the anchoring balloon 4 is quickly anchored in the guiding channel 201a of the guiding catheter 201 and blocked, so that the guiding suction catheter 100 is sealed with the guiding catheter 201. When the thrombus or plaque is subsequently aspirated, the suction pressure will not be reduced here, and the guiding suction catheter 100 can also be prevented from moving. When the anchoring balloon 4 is filled, it can anchor the guide wire 202, and during the doctor's operation, it prevents the guide wire 202 from moving forward and backward, avoiding damage to the blood vessel caused by the movement of the guide suction catheter 100 or the guide wire 202. In addition, since the distal end of the delivery member 2 is fixed in the wall of the catheter body 1, the delivery member 2 can be hidden in the middle of the material of the catheter body 1, so that the delivery member 2 does not cause damage to the blood vessel. Specifically, the delivery member 2 is provided with a plurality of through holes 22, and the through holes 22 are distributed in the middle of the balloon.
请参阅图1至图4，图10，在一实施例中，递送件2的内部呈空心结构，充盈通道21形成于空心结构内，递送件2的远端延伸至对应锚定球囊4的位置处。但不以此为限，举例而言，在其他的实施例中，递送件2的近端呈空心结构，充盈通道21形成于空心结构内。Please refer to Figures 1 to 4 and 10. In one embodiment, the interior of the delivery member 2 is a hollow structure, the filling channel 21 is formed in the hollow structure, and the distal end of the delivery member 2 extends to the position corresponding to the anchoring balloon 4. However, this is not limited to this. For example, in other embodiments, the proximal end of the delivery member 2 is a hollow structure, and the filling channel 21 is formed in the hollow structure.
在另一实施例中，递送件2向远端延伸，递送件2的远端呈实心结构，通过将递送件2的远端设置为实心结构，使得推送力可较好地传递。进一步地，空心结构23的外径大于实心结构24的外径，从而保证推送杆递送件2在空心结构23的位置处的强度。In another embodiment, the delivery member 2 extends to the distal end, and the distal end of the delivery member 2 is a solid structure. By setting the distal end of the delivery member 2 as a solid structure, the pushing force can be better transmitted. Furthermore, the outer diameter of the hollow structure 23 is greater than the outer diameter of the solid structure 24, thereby ensuring the strength of the push rod delivery member 2 at the position of the hollow structure 23.
在介入治疗的过程中，操作者可直接握持递送手柄3将导管主体1平稳在人体内推进，递送件2为导引抽吸导管100提供了良好的支撑力和推送力，以保证手术的顺利进行。其中，递送件2可由不锈钢制成，外表面均作抛光处理，以提高介入治疗的安全性。During the interventional treatment, the operator can directly hold the delivery handle 3 to smoothly push the catheter body 1 into the human body, and the delivery member 2 provides good support and pushing force for the guide suction catheter 100 to ensure the smooth progress of the operation. The delivery member 2 can be made of stainless steel, and the outer surface is polished to improve the safety of the interventional treatment.
请参阅图1以及图10至图12，在一实施例中，导管主体1的导入口12呈斜口结构，可使本发明的导引抽吸导管100具备更好推送性传递。斜口结构与导管主体1的轴向夹角可以为0-90度，但不限于此。Referring to Figures 1 and 10 to 12, in one embodiment, the introduction port 12 of the catheter body 1 is an oblique structure, which can make the guide suction catheter 100 of the present invention have better push transmission. The axial angle between the oblique structure and the catheter body 1 can be 0-90 degrees, but is not limited thereto.
导入口12可作为器械进出的通道，还可以作为血栓300抽吸的通道，例如外接的导管或者支架等可以从导入口12进入到导管主体1的延长通道11中并贯穿移动至导管主体1的远端，这样导引抽吸导管100可以作为快速交换型导管，从而通过实现器械的快速交换；又如，还可以将导入口12通过指引导管201与注射器连接，以便于通过注射器实现血栓300的抽吸。The introduction port 12 can be used as a channel for the entry and exit of instruments, and can also be used as a channel for aspirating the thrombus 300. For example, an external catheter or stent can enter the extension channel 11 of the catheter body 1 from the introduction port 12 and move through it to the distal end of the catheter body 1. In this way, the guide aspiration catheter 100 can be used as a rapid exchange catheter, thereby achieving rapid exchange of instruments; for example, the introduction port 12 can also be connected to a syringe through the guiding catheter 201 to facilitate the aspiration of the thrombus 300 through the syringe.
请参阅图1及图3，在一实施例中，锚定球囊4真空平整贴合在导管主体1的外层15，锚定球囊4的远端与导管主体1的外层15紧密焊接或粘接，从而形成密封端；锚定球囊4的近端与导管外层15、递送件2的远端紧密焊接，整个锚定球囊4两端的焊接或粘接处，平顺过渡，无明显凹凸手感，进入其他通道器械更顺畅，低阻力。具体地，锚定球囊4可以是顺应性球囊，这里的顺应性球囊是指锚定球囊4扩张到预定直径后，随充盈压力的增加，其直径和容积可不断增加。锚定球囊4可由尼龙、聚乙烯、聚氨酯或聚对苯二甲酸乙二醇酯材料制成。Please refer to Figures 1 and 3. In one embodiment, the anchoring balloon 4 is vacuum-flattened and attached to the outer layer 15 of the catheter body 1. The distal end of the anchoring balloon 4 is tightly welded or bonded to the outer layer 15 of the catheter body 1 to form a sealed end. The proximal end of the anchoring balloon 4 is tightly welded to the outer layer 15 of the catheter and the distal end of the delivery member 2. The welding or bonding at both ends of the entire anchoring balloon 4 has a smooth transition without obvious uneven feel, and it is smoother to enter other channel instruments with low resistance. Specifically, the anchoring balloon 4 can be a compliant balloon, and the compliant balloon here means that after the anchoring balloon 4 is expanded to a predetermined diameter, its diameter and volume can continue to increase with the increase of filling pressure. The anchoring balloon 4 can be made of nylon, polyethylene, polyurethane or polyethylene terephthalate.
在一实施例中，导管主体1的外层15在靠近锚定球囊4的位置处设有显影元件6，但不以此为限。进一步地，导管主体1的远端也可设置显影元件6，但不以此为限。在造影操作中，显影元件6可显示黑影，为操作者提供位置信息。显影元件6可采用不透X射线的显影材料制成，显影材料为黄金、钨、铂金、铂铱合金中的一种或多种。显影元件6可以是显影环，也可以是圆柱螺旋状的显影线圈，也可以是涂覆在导管主体1的侧壁上的显影涂层。具体地，显影元件6优选为显影环，这样能够帮助操作者快速捕捉导管主体1和锚定球囊4的位置。In one embodiment, the outer layer 15 of the catheter body 1 is provided with a developing element 6 at a position close to the anchoring balloon 4, but the present invention is not limited thereto. Furthermore, the developing element 6 may also be provided at the distal end of the catheter body 1, but the present invention is not limited thereto. During the angiography operation, the developing element 6 may display a black shadow to provide position information to the operator. The developing element 6 may be made of an X-ray-opaque developing material, and the developing material may be one or more of gold, tungsten, platinum, and platinum-iridium alloy. The developing element 6 may be a developing ring, or a cylindrical spiral developing coil, or a developing coating coated on the side wall of the catheter body 1. Specifically, the developing element 6 is preferably a developing ring, which can help the operator quickly capture the position of the catheter body 1 and the anchoring balloon 4.
请参阅图11及图12，在一实施例中，指引导管201的近端设有导管座203，导管座203具有第一接口203a和第二接口203b，第一接口203a和第二接口203b分别与指引通道201a连通，导丝202和导引抽吸导管100均穿插于第一接口203a内，且递送件2的近端位于导管座203的外侧，第二接口203b用于流体输送或抽吸。Please refer to Figures 11 and 12. In one embodiment, a catheter seat 203 is provided at the proximal end of the guiding catheter 201. The catheter seat 203 has a first interface 203a and a second interface 203b. The first interface 203a and the second interface 203b are respectively connected to the guiding channel 201a. The guide wire 202 and the guiding suction catheter 100 are both inserted into the first interface 203a, and the proximal end of the delivery member 2 is located on the outside of the catheter seat 203. The second interface 203b is used for fluid delivery or suction.
在一实施例中，当本发明的导引抽吸导管100完成锚定操作后，可通过指引导管201上的导管座203注射造影剂或其他流体介质，该介质可沿着指引导管201的指引通道201a顺流到进行导引抽吸导管100的导管主体1的延长通道11内，进行超选择性造影，或其他靶向治疗。In one embodiment, after the guide suction catheter 100 of the present invention completes the anchoring operation, contrast agent or other fluid medium can be injected through the catheter seat 203 on the guiding catheter 201. The medium can flow along the guiding channel 201a of the guiding catheter 201 to the extension channel 11 of the catheter body 1 of the guiding suction catheter 100 to perform super-selective angiography or other targeted treatments.
在一实施例中，当本发明的导引抽吸导管100完成锚定操作后，可用相关的抽吸器械通过指引导管201上的导管座203对血管进行抽吸血栓300、钙化斑块等操作。血栓300或钙化斑块等可在负压力作用下沿着导引抽吸导管100的导管主体1的延长通道11回流到指引导管201的指引通道201a，最后被抽出体外。In one embodiment, after the guiding suction catheter 100 of the present invention completes the anchoring operation, a related suction device can be used to suction thrombus 300, calcified plaque, etc. from the blood vessel through the catheter seat 203 on the guiding catheter 201. The thrombus 300 or calcified plaque, etc. can flow back to the guiding channel 201a of the guiding catheter 201 along the extension channel 11 of the catheter body 1 of the guiding suction catheter 100 under the action of negative pressure, and finally be sucked out of the body.
结合图1至图13，以进入小血管来进行抽吸血栓300为例，本发明的导管系统200具体工作原理如下：1 to 13 , taking entering a small blood vessel to aspirate a thrombus 300 as an example, the specific working principle of the catheter system 200 of the present invention is as follows:
进入目标区：血栓300在小血管，输送指引导管201至靠近小血管的较大血管，沿指引导管201近端的导管座203的第一接口203a输送导丝202至小血管的血栓300处。将导丝管5沿导丝202输送导引抽吸导管100，导引抽吸导管100从指引导管201的近端的导管座203的第一接口203a伸入指引导管201。导引抽吸导管100的导管主体1的远端从指引导管201的远端露出，导管主体1的近端位于指引通道201a内，递送件2的一端位于指引通道201a内，递送件2的另一端从导管座203的第一接口203a露出，递送手柄3位于导管座203外。在导丝202的指引下，导管主体1进入指锚定置，由于导管主体1内含递送件2，可以由递送件2使力，使得指引导管201容易进入分支血管和狭小血管。Entering the target area: The thrombus 300 is in a small blood vessel, the guiding catheter 201 is transported to a larger blood vessel near the small blood vessel, and the guide wire 202 is transported to the thrombus 300 in the small blood vessel along the first interface 203a of the catheter seat 203 at the proximal end of the guiding catheter 201. The guide wire tube 5 is transported to the guiding suction catheter 100 along the guide wire 202, and the guiding suction catheter 100 extends into the guiding catheter 201 from the first interface 203a of the catheter seat 203 at the proximal end of the guiding catheter 201. The distal end of the catheter body 1 of the guiding suction catheter 100 is exposed from the distal end of the guiding catheter 201, the proximal end of the catheter body 1 is located in the guiding channel 201a, one end of the delivery member 2 is located in the guiding channel 201a, the other end of the delivery member 2 is exposed from the first interface 203a of the catheter seat 203, and the delivery handle 3 is located outside the catheter seat 203. Under the guidance of the guide wire 202, the catheter body 1 enters the finger anchoring position. Since the catheter body 1 contains the delivery component 2, the delivery component 2 can exert force, so that the guiding catheter 201 can easily enter the branch blood vessels and narrow blood vessels.
建立传输通道：经递送手柄3的内腔和递送件2内的充盈通道21充盈锚定球囊4，锚定球囊4扩张后锚定在指引通道201a内，锚定球囊4将指引导管201与导管主体1之间的间隙封堵，指引通道201a与导管腔连通。Establishing a transmission channel: filling the anchoring balloon 4 through the inner cavity of the delivery handle 3 and the filling channel 21 in the delivery member 2, and anchoring the anchoring balloon 4 in the guiding channel 201a after expansion, the anchoring balloon 4 blocks the gap between the guiding catheter 201 and the catheter body 1, and the guiding channel 201a is connected to the catheter cavity.
输送造影剂/药物：将指引导管201的导管座203处伸出递送件2的第一接口203a封堵，在导管座203的第二接口203b输送造影剂/药物，造影剂/药物沿指引通道201a流向导管主体1的延长通道11内，然后在导管主体1远端流出，造影剂/药物流向小血管远端，从而进行超选择性造影/靶向施药。Delivery of contrast agent/drug: The first interface 203a of the delivery member 2 extending out of the catheter seat 203 of the guiding catheter 201 is blocked, and the contrast agent/drug is delivered at the second interface 203b of the catheter seat 203. The contrast agent/drug flows along the guiding channel 201a into the extension channel 11 of the catheter body 1, and then flows out at the distal end of the catheter body 1. The contrast agent/drug flows to the distal end of the small blood vessels, thereby performing super-selective angiography/targeted drug administration.
外接抽吸器抽吸血栓300、斑块：将指引导管201的导管座203处伸出递送件2的第一接口203a封堵，在导管座203的第二接口203b连接抽吸器，抽吸导管主体1远端的血栓300、斑块。血栓300或钙化斑块等在负压力作用下沿着导管主体1的延长通道11回流到指引通道201a，直到被抽出体外。An external suction device is used to suck out the thrombus 300 and plaque: the first interface 203a of the delivery member 2 extending out of the catheter seat 203 of the guiding catheter 201 is blocked, and the suction device is connected to the second interface 203b of the catheter seat 203 to suck out the thrombus 300 and plaque at the distal end of the catheter body 1. Under the action of negative pressure, the thrombus 300 or calcified plaque flows back to the guiding channel 201a along the extension channel 11 of the catheter body 1 until it is sucked out of the body.
导丝202(或导引抽吸导管100)的撤回：使用压力泵负压状态下回抽锚定球囊4内的介质。在X射线透视下，确定锚定球囊4抽瘪且无介质残留，整体回撤导丝202(或导引抽吸导管100)，直至退出体外。Withdrawal of the guide wire 202 (or the guide suction catheter 100): Use a pressure pump to withdraw the medium in the anchoring balloon 4 under negative pressure. Under X-ray fluoroscopy, confirm that the anchoring balloon 4 is deflated and no medium remains, and withdraw the guide wire 202 (or the guide suction catheter 100) as a whole until it is out of the body.
综上，本发明的导管系统200具有导引抽吸导管100，该导引抽吸导管100通过在导管主体1的导管方向并列地连接有导丝管5，使得导丝202可穿过该导丝管5的导丝腔51而不占据导管主体1的延长通道11的面积，使得通过指引通道201a和延长通道11进行抽吸的抽吸通路顺畅，有效抽吸面积相对较大，可避免导丝202对管腔的有效抽吸面积造成影响，并提高抽吸效果，同时，穿过导丝腔51的导丝202也可对导管主体1进行引导锚定，保证导引抽吸导管100可准确地输送至靶区。此外，由于导丝202不占据导管主体1的延长通道11的面积，有效抽吸面积相对较大，对于大块血栓300抽吸能力更好，减少并发症。还有，本发明的导引抽吸导管100既可作为导引器械深插到血管更远的位置，又可实现血栓300和斑块抽吸的功能，减少因血栓300抽吸导致的血栓事件，减少器械之间的交换，提升手术效率。In summary, the catheter system 200 of the present invention has a guide suction catheter 100, which is connected to a guide wire tube 5 in parallel in the catheter direction of the catheter body 1, so that the guide wire 202 can pass through the guide wire cavity 51 of the guide wire tube 5 without occupying the area of the extension channel 11 of the catheter body 1, so that the suction path for suction through the guide channel 201a and the extension channel 11 is smooth, and the effective suction area is relatively large, which can avoid the influence of the guide wire 202 on the effective suction area of the lumen and improve the suction effect. At the same time, the guide wire 202 passing through the guide wire cavity 51 can also guide and anchor the catheter body 1, ensuring that the guide suction catheter 100 can be accurately delivered to the target area. In addition, since the guide wire 202 does not occupy the area of the extension channel 11 of the catheter body 1, the effective suction area is relatively large, and the suction ability for large thrombi 300 is better, reducing complications. In addition, the guide aspiration catheter 100 of the present invention can be used as a guide device to be inserted deeply into a farther position of the blood vessel, and can also realize the function of aspirating thrombus 300 and plaque, thereby reducing thrombotic events caused by aspiration of thrombus 300, reducing the exchange between devices, and improving surgical efficiency.
以上所揭露的仅为本发明的较佳实例而已，不能以此来限定本发明之权利范围，因此依本发明权利要求所作的等同变化，均属于本发明所涵盖的范围。The above disclosure is only a preferred embodiment of the present invention, which cannot be used to limit the scope of the present invention. Therefore, equivalent changes made according to the claims of the present invention are all within the scope of the present invention.
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202410667874.6ACN118477216A (en) | 2024-05-27 | 2024-05-27 | Guide suction catheter and catheter system having the same |
| PCT/CN2024/117544WO2025055831A1 (en) | 2023-09-11 | 2024-09-06 | Guide extension type aspiration catheter, and thrombus aspiration catheter system and method |
| PCT/CN2024/117545WO2025055832A1 (en) | 2023-09-11 | 2024-09-06 | Extension aspiration catheter, catheter system, and method |
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202410667874.6ACN118477216A (en) | 2024-05-27 | 2024-05-27 | Guide suction catheter and catheter system having the same |
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202510910806.2ADivisionCN120789358A (en) | 2024-05-27 | Guiding suction catheter and catheter system having the same |
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| CN118477216Atrue CN118477216A (en) | 2024-08-13 |
| Application Number | Title | Priority Date | Filing Date |
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| CN202410667874.6APendingCN118477216A (en) | 2023-09-11 | 2024-05-27 | Guide suction catheter and catheter system having the same |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| WO2025055832A1 (en)* | 2023-09-11 | 2025-03-20 | 广东博迈医疗科技股份有限公司 | Extension aspiration catheter, catheter system, and method |
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102319097A (en)* | 2011-08-04 | 2012-01-18 | 东莞永胜医疗制品有限公司 | Thrombus aspiration catheter and method of use thereof |
| CN109498968A (en)* | 2019-01-15 | 2019-03-22 | 科塞尔医疗科技（苏州）有限公司 | A kind of seal wire anchoring balloon component |
| CN210750821U (en)* | 2019-05-07 | 2020-06-16 | 深圳市业聚实业有限公司 | Guide extension catheter for fixing guide wire |
| CN117323476A (en)* | 2023-11-14 | 2024-01-02 | 广东博迈医疗科技股份有限公司 | Extended suction catheter and catheter system having the same |
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102319097A (en)* | 2011-08-04 | 2012-01-18 | 东莞永胜医疗制品有限公司 | Thrombus aspiration catheter and method of use thereof |
| CN109498968A (en)* | 2019-01-15 | 2019-03-22 | 科塞尔医疗科技（苏州）有限公司 | A kind of seal wire anchoring balloon component |
| CN210750821U (en)* | 2019-05-07 | 2020-06-16 | 深圳市业聚实业有限公司 | Guide extension catheter for fixing guide wire |
| CN117323476A (en)* | 2023-11-14 | 2024-01-02 | 广东博迈医疗科技股份有限公司 | Extended suction catheter and catheter system having the same |
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2025055832A1 (en)* | 2023-09-11 | 2025-03-20 | 广东博迈医疗科技股份有限公司 | Extension aspiration catheter, catheter system, and method |
| WO2025055831A1 (en)* | 2023-09-11 | 2025-03-20 | 广东博迈医疗科技股份有限公司 | Guide extension type aspiration catheter, and thrombus aspiration catheter system and method |
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| TA01 | Transfer of patent application right | Effective date of registration:20241120 Address after:523000 Room 301, building 15, No.1, North 4th Industrial Road, Songshanhu Park, Dongguan City, Guangdong Province Applicant after:Guangdong Bomai Medical Technology Co.,Ltd. Country or region after:China Applicant after:Guangdong Bomai Yuantong Medical Technology Co.,Ltd. Address before:523000 Room 301, building 15, No.1, North 4th Industrial Road, Songshanhu Park, Dongguan City, Guangdong Province Applicant before:Guangdong Bomai Medical Technology Co.,Ltd. Country or region before:China | |
| TA01 | Transfer of patent application right |