在治疗例如血管狭窄病变或血栓堵塞病变中，需要额外使用进行过滤保护的辅助器械，如使用支架治疗颈动脉狭窄所使用的脑保护装置。现有技术中，通常使用保护伞来过滤血栓斑块，但是由于保护伞压缩后直径较大，在通过血管狭窄病变部位或者血栓堵塞病变部位时易使病变部位的斑块或血栓脱落，同时，在保护装置通过病变部位时血液还在流通，容易使脱落的斑块或血栓随血液流到直径更细的血管处堵塞血管造成严重后果。In the treatment of e.g. vascular stenosis lesions or thrombotic occlusion lesions, it is necessary to additionally use auxiliary devices for filter protection, such as brain protection devices used in the treatment of carotid artery stenosis with stents. In the prior art, protective umbrellas are usually used to filter thrombus plaques. However, due to the large diameter of the protective umbrella after compression, plaques or thrombus in the lesion are easy to fall off when passing through the vascular stenosis lesion or thrombus blocking the lesion. At the same time, in the protection When the device passes through the lesion, the blood is still circulating, and it is easy for the shed plaque or thrombus to flow with the blood to the blood vessel with a smaller diameter to block the blood vessel and cause serious consequences.

发明内容Contents of the invention

本发明的目的在于提供一种能够有效过滤脱落的斑块或血栓的球囊保护伞套件。The object of the present invention is to provide a balloon umbrella kit capable of effectively filtering exfoliated plaque or thrombus.

本发明的球囊保护伞套件包括球囊组件和保护伞组件，所述球囊组件包括第一鞘管，以及设置于所述第一鞘管的可膨胀的球囊；所述保护伞组件包括杆部件、设置于所述杆部件的至少一个自膨胀的保护伞以及第二鞘管，其中，所述第二鞘管能够通过所述第一鞘管的内腔输送，设置于所述杆部件的所述至少一个保护伞能够通过所述第二鞘管的内腔输送，所述保护伞设置成能够以未膨胀状态收纳于所述第二鞘管的内腔并且从第二鞘管的内腔输送出后呈膨胀状态。The balloon umbrella kit of the present invention includes a balloon assembly and an umbrella assembly, the balloon assembly includes a first sheath, and an inflatable balloon disposed on the first sheath; the umbrella assembly includes a rod component, at least one self-expanding protective umbrella and a second sheath disposed on the shaft member, wherein the second sheath can be delivered through the lumen of the first sheath, and the at least one self-expanding sheath disposed on the shaft member a protective umbrella is deliverable through the lumen of the second sheath, the umbrella is configured to be received in the lumen of the second sheath in an unexpanded state and to be inflated after being delivered out of the lumen of the second sheath state.

在一些实施方式中，所述第一鞘管包括内层鞘管和套在内层鞘管外的外层鞘管，所述内层鞘管与外层鞘管彼此沿轴向能够相对移动，所述球囊的一端与所述内层鞘管连接，球囊的另一端与所述外层鞘管连接，通过控制内层鞘管与外层鞘管之间的相对移动以控制所述球囊的膨胀和收缩。优选地，所述球囊包括由至少一根编织丝编织而成的支架以及覆盖在所述支架外的薄膜。In some embodiments, the first sheath includes an inner sheath and an outer sheath sheathed outside the inner sheath, and the inner sheath and the outer sheath can move relative to each other in the axial direction, One end of the balloon is connected to the inner sheath, the other end of the balloon is connected to the outer sheath, and the balloon is controlled by controlling the relative movement between the inner sheath and the outer sheath. Expansion and contraction of the sac. Preferably, the balloon includes a stent braided by at least one braided wire and a membrane covering the stent.

在一些实施方式中，所述第一鞘管上设置有流体注入孔，通过所述流体注入孔向所述球囊中填充流体以控制所述球囊的膨胀和收缩。In some embodiments, the first sheath is provided with a fluid injection hole, and the balloon is filled with fluid through the fluid injection hole to control the expansion and contraction of the balloon.

在一些实施方式中，所述至少一个保护伞由至少一根编织丝编织而成，所述编织丝为镍钛合金丝。所述编织而成的保护伞膨胀后的孔隙密度为120～250ppi。In some embodiments, the at least one protective umbrella is braided by at least one braided wire, and the braided wire is a nickel-titanium alloy wire. The pore density of the woven protective umbrella after expansion is 120-250ppi.

在一些实施方式中，所述至少一个保护伞为激光雕刻的镍钛合金部件，其外侧覆盖有微孔膜。所述微孔膜膨胀后的微孔的大小为100～240μm。In some embodiments, the at least one umbrella is a laser-engraved nitinol component covered on the outside with a microporous membrane. The size of the micropores of the expanded microporous membrane is 100-240 μm.

在一些实施方式中，所述至少一个保护伞外侧还覆盖有水凝胶。In some embodiments, the outside of the at least one umbrella is also covered with hydrogel.

在一些实施方式中，所述至少一个保护伞为伞形、球形、梭形或橄榄形。In some embodiments, the at least one umbrella is umbrella-shaped, spherical, fusiform, or olive-shaped.

在一些实施方式中，膨胀后的所述至少一个保护伞的外径为5～8mm。In some embodiments, the outer diameter of the at least one protective umbrella after expansion is 5-8 mm.

在一些实施方式中，保护伞的数量为两个，两个保护伞之间的间距为30～80mm。可选地，两个保护伞的直径不同。直径较大的保护伞与所述球囊之间的距离较小。In some embodiments, there are two protective umbrellas, and the distance between the two protective umbrellas is 30-80mm. Optionally, the diameters of the two umbrellas are different. The larger diameter umbrella has a smaller distance from the balloon.

在一些实施方式中，所述保护伞通过金属薄壁管铆接、粘接或焊接于所述杆部件上。所述金属选自：不锈钢、铂铱合金、钽、铂金。所述杆部件为导丝或导管，所述导丝的直径选自0.014”、0.018”或0.035”，所述导管的外径选自3F、4F、5F、6F。In some embodiments, the protective umbrella is riveted, bonded or welded to the rod member through a metal thin-walled tube. The metal is selected from: stainless steel, platinum-iridium alloy, tantalum, platinum. The rod part is a guide wire or a catheter, the diameter of the guide wire is selected from 0.014", 0.018" or 0.035", and the outer diameter of the catheter is selected from 3F, 4F, 5F, 6F.

本发明所提供的球囊保护伞套件中，球囊和保护伞的双重配合可以更好的防止斑块的脱落及移动。In the balloon protective umbrella set provided by the present invention, the double cooperation of the balloon and the protective umbrella can better prevent plaque from falling off and moving.

以下将结合附图和具体实施方式对本发明的技术方案和由此带来的优点进行进一步详细描述。The technical solution of the present invention and the advantages brought about by it will be further described in detail below with reference to the drawings and specific embodiments.

附图说明Description of drawings

图1是根据本发明的一种实施方式的球囊保护伞套件的结构示意图；Fig. 1 is a schematic structural view of a balloon umbrella kit according to an embodiment of the present invention;

图2是图1中的球囊保护伞套件的保护伞与杆部件之间的连接关系的示意图；Fig. 2 is a schematic diagram of the connection relationship between the umbrella and the rod part of the balloon umbrella kit in Fig. 1;

图3a至图3c中是图1中的球囊保护伞套件的保护伞的实施例的结构示意图；Figures 3a to 3c are schematic structural views of embodiments of the umbrella of the balloon umbrella kit in Figure 1;

图4是根据本发明的另一种实施方式的球囊保护伞套件的结构示意图；Fig. 4 is a schematic structural view of a balloon umbrella kit according to another embodiment of the present invention;

图5a和图5b为图4中的球囊保护伞套件的球囊组件的实施例的结构示意图；Figure 5a and Figure 5b are schematic structural views of embodiments of the balloon assembly of the balloon umbrella kit in Figure 4;

图6是根据本发明的又一种实施方式的球囊保护伞套件的结构示意图。Fig. 6 is a schematic structural view of a balloon umbrella kit according to another embodiment of the present invention.

具体实施方式Detailed ways

以下结合附图和具体实施方式对本发明涉及的各个方面进行详细阐述。其中，附图中的部件并非一定是按比例进行绘制，其重点在于对本发明的构思进行举例说明。Various aspects involved in the present invention will be described in detail below with reference to the drawings and specific embodiments. Wherein, the components in the drawings are not necessarily drawn to scale, and the emphasis is on illustrating the concept of the present invention by way of example.

在本发明的各个具体实施方式中，对其中涉及的众所周知的结构或材料未作详细说明。并且，本发明所描述的特征、结构或特性可在一个或多个实施方式中以任何方式组合。此外，本领域技术人员应当理解，下述的各种实施方式只用于举例说明，而非用于限定本发明的保护范围。本领域技术人员可以理解，本文所描述的和附图所示的各实施方式中的部件可以按多种不同配置或比例进行布置和设计。In each specific embodiment of the present invention, well-known structures or materials involved therein are not described in detail. Furthermore, the described features, structures or characteristics of the invention may be combined in any manner in one or more embodiments. In addition, those skilled in the art should understand that the various implementations described below are only for illustration, rather than limiting the protection scope of the present invention. Those skilled in the art can understand that the components in the embodiments described herein and shown in the accompanying drawings can be arranged and designed in various configurations or ratios.

【术语解释】【Explanation of terms】

ppi是用于表示孔隙密度的单位，即单位英寸长度上的平均孔数。ppi is the unit used to express pore density, which is the average number of pores per inch of length.

F为英文French的简写，是用于表示导管尺寸的单位。F is the abbreviation of French in English, which is the unit used to express the size of the catheter.

对于未在本说明书中进行具体说明的技术术语，除非另有特定说明，都应以本领域最宽泛的意思进行解释。For technical terms that are not specifically described in this specification, unless otherwise specified, they should be interpreted with the broadest meaning in the field.

【第一实施方式】[First Embodiment]

图1是根据本发明一种实施方式的球囊保护伞套件的结构示意图。如图1所示，本实施方式中的球囊保护伞套件包括球囊组件和保护伞组件，其中，球囊组件包括第一鞘管1和设置于第一鞘管1的可膨胀的球囊2，该保护伞组件包括杆部件3、设置于杆部件3的自膨胀的保护伞4和第二鞘管5，第二鞘管5能够通过第一鞘管1的内腔输送，设置于杆部件3的保护伞4能够通过第二鞘管5的内腔输送，保护伞4设置成能够以未膨胀状态收纳于第二鞘管5的内腔并且从第二鞘管5的内腔输送出后呈膨胀状态。Fig. 1 is a schematic structural view of a balloon umbrella kit according to an embodiment of the present invention. As shown in FIG. 1 , the balloon umbrella kit in this embodiment includes a balloon assembly and an umbrella assembly, wherein the balloon assembly includes a first sheath tube 1 and an inflatable balloon 2 disposed on the first sheath tube 1 , The protective umbrella assembly includes a rod part 3, a self-expanding protective umbrella 4 arranged on the rod part 3 and a second sheath tube 5, the second sheath tube 5 can be delivered through the lumen of the first sheath tube 1, and the protective umbrella arranged on the rod part 3 4 can be delivered through the lumen of the second sheath tube 5, and the protective umbrella 4 is set to be accommodated in the lumen of the second sheath tube 5 in an unexpanded state and in an expanded state after being delivered out of the lumen of the second sheath tube 5.

在操作时，先在近端的正常血管中释放球囊并使球囊膨胀，在近端对血流形成阻断，随后将第二鞘管5从第一鞘管1的内腔中推出至目标位置(经过狭窄或病变部位后的远端)，回撤第二鞘管5使得保护伞从第二鞘管5的内腔输送出并在该目标位置释放膨胀，以在远端形成过滤式保护，此时再收缩球囊并对病变部位进行操作。对病变部位进行操作(例如装配支架等)时，球囊收缩，保护伞在远端形成保护，此时不影响正常血液流通。可选地，也可以将第二鞘管5从第一鞘管1的内腔中推出后，再将设置有保护伞4的杆部件3从第二鞘管5的内腔中推出，使得保护伞从第二鞘管5的内腔输送出至目标位置(经过狭窄或病变部位后的远端)释放膨胀。During operation, the balloon is first released and inflated in the normal blood vessel at the proximal end to block the blood flow at the proximal end, and then the second sheath tube 5 is pushed out from the lumen of the first sheath tube 1 to the At the target location (distal after passing the stenosis or lesion), withdraw the second sheath 5 so that the protective umbrella is delivered from the lumen of the second sheath 5 and releases the inflation at the target location to form a filtering protection at the distal end , then deflate the balloon and operate on the lesion. When the lesion is operated (such as stent assembly, etc.), the balloon shrinks, and the protective umbrella forms protection at the distal end, which does not affect the normal blood circulation at this time. Optionally, after the second sheath tube 5 can be pushed out from the lumen of the first sheath tube 1, the rod part 3 provided with the protective umbrella 4 can be pushed out from the lumen of the second sheath tube 5, so that the protective umbrella can be pushed out from the lumen of the first sheath tube 1. The lumen of the second sheath tube 5 is delivered to the target position (the distal end after passing through the stenosis or lesion) to release the expansion.

这样，近端的球囊膨胀可以阻断血流，防止保护伞经过病变部位时可能造成的斑块脱落，待完全经过病变部位后再释放保护伞，保护伞在远端可以形成保护，进一步过滤斑块，防止大斑块沿血流方向流入其他部位，球囊和保护伞的双重配合可以更好的防止斑块的脱落移动。In this way, the expansion of the balloon at the proximal end can block the blood flow and prevent the plaque from falling off when the protective umbrella passes through the lesion. After the lesion is completely passed, the protective umbrella can be released. The protective umbrella can form a protection at the distal end to further filter the plaque. To prevent large plaques from flowing into other parts along the direction of blood flow, the double cooperation of the balloon and the protective umbrella can better prevent plaques from falling off and moving.

本实施方式中可以控制球囊膨胀成球形，形成封堵横截面以阻断血流通过，在对病变部位进行操作时也可以控制球囊使其收缩。In this embodiment, the balloon can be controlled to expand into a spherical shape to form a blocking cross section to block the passage of blood flow, and the balloon can also be controlled to shrink when the lesion is operated.

例如，球囊为阻断球囊。如图1所示，在第一鞘管1上设置有流体注入孔11，通过流体注入孔11向球囊2中填充流体以控制球囊的膨胀和收缩。For example, the balloon is a blocking balloon. As shown in FIG. 1 , a fluid injection hole 11 is provided on the first sheath tube 1 , and the balloon 2 is filled with fluid through the fluid injection hole 11 to control the expansion and contraction of the balloon.

在保护伞组件中，保护伞4的至少一端固定于杆部件3。为了说明保护伞4与杆部件3的固定，图2中显示了保护伞的一端(例如近端)与杆部件之间的连接关系。如图2所示，保护伞4可以通过金属薄壁管6铆接、粘接或焊接于杆部件3上。该金属薄壁管6可以是不锈钢管、铂铱合金管、钽管或铂金管。杆部件3可以为导丝或导管，导丝的直径优选为0.014”、0.018”或0.035”，导管的外径优选为3F、4F、5F、6F。In the umbrella assembly, at least one end of the umbrella 4 is fixed to the rod member 3 . In order to illustrate the fixing of the protective umbrella 4 and the rod part 3 , the connection relationship between one end (for example, the proximal end) of the protective umbrella and the rod part is shown in FIG. 2 . As shown in FIG. 2 , the protective umbrella 4 can be riveted, glued or welded on the rod part 3 through a metal thin-walled tube 6 . The metal thin-walled tube 6 may be a stainless steel tube, a platinum-iridium alloy tube, a tantalum tube or a platinum tube. The rod part 3 can be a guide wire or a catheter, the diameter of the guide wire is preferably 0.014", 0.018" or 0.035", and the outer diameter of the catheter is preferably 3F, 4F, 5F, 6F.

为了说明保护伞4的结构，图3a至图3c中显示了保护伞的几种实施例。In order to illustrate the structure of the umbrella 4, several embodiments of the umbrella are shown in Figs. 3a to 3c.

在本实施方式中，自膨胀的保护伞4由至少一根编织丝编织而成，编织丝为镍钛合金丝。所述编织而成的保护伞膨胀后的孔隙密度为120～250ppi。这样的编织而成的保护伞具有更好的贴壁效果，可以有效防止斑块或血栓从间隙越过。编织而成的保护伞4外侧还可以覆盖有微孔膜(未示出)，微孔膜膨胀后的微孔大小为100～240μm。膨胀后的保护伞的外径为5～8mm。In this embodiment, the self-expanding umbrella 4 is braided by at least one braided wire, and the braided wire is a nickel-titanium alloy wire. The pore density of the woven protective umbrella after expansion is 120-250ppi. Such a woven protective umbrella has a better wall-adhering effect and can effectively prevent plaque or thrombus from passing through the gap. The outer side of the braided protective umbrella 4 may also be covered with a microporous membrane (not shown), and the micropore size of the expanded microporous membrane is 100-240 μm. The outer diameter of the expanded protective umbrella is 5-8mm.

例如，保护伞可以为伞形(漏斗形)(如图3a所示)、球形(如图3b所示)、梭形或橄榄形。如图3a所示，当保护伞为伞形时，其由伞面部分41和伞架42组成，伞面部分41位于远端，由至少一根编织丝编织而成，以防止斑块或血栓越过随血液流向远端；伞架42位于近端，与杆部件3相固定。For example, the umbrella can be umbrella-shaped (funnel-shaped) (as shown in Figure 3a), spherical (as shown in Figure 3b), fusiform or olive-shaped. As shown in Figure 3a, when the umbrella is umbrella-shaped, it consists of a canopy part 41 and an umbrella frame 42, the canopy part 41 is located at the distal end and is woven by at least one braided wire to prevent plaque or thrombus from passing over With the blood flowing to the far end; the umbrella stand 42 is located at the proximal end and is fixed with the rod part 3 .

可选地，如图3c所示，保护伞也可以是激光雕刻而成的镍钛合金部件(例如，微孔球，或者也可以是其他形状，例如漏斗形、梭形或橄榄形等)。激光雕刻出的孔隙在膨胀后的大小为100～240μm。可选地，其外侧还可以覆盖有微孔膜(未示出)，微孔膜膨胀后的微孔大小为100～240μm。膨胀后的保护伞的外径为5～8mm。Optionally, as shown in FIG. 3 c , the protective umbrella can also be a nickel-titanium alloy part (for example, microporous spheres, or other shapes, such as funnel-shaped, shuttle-shaped or olive-shaped, etc.) formed by laser engraving. The size of the laser-engraved pores after expansion is 100-240 μm. Optionally, the outside thereof may be covered with a microporous membrane (not shown), and the micropore size of the expanded microporous membrane is 100-240 μm. The outer diameter of the expanded protective umbrella is 5-8mm.

在优选的实施方式中，保护伞外侧还可以覆盖有水凝胶，以使保护伞能够具有更好的贴壁性。In a preferred embodiment, the outer side of the protective umbrella can also be covered with hydrogel, so that the protective umbrella can have better adhesion to the wall.

在本实施方式中，第二鞘管5可以是单腔的，供杆部件和保护伞通过。可选地，第二鞘管也可以是多腔的，以便于输送药物或其他装置。In this embodiment, the second sheath tube 5 may be single lumen, through which the rod member and the protective umbrella pass. Optionally, the second sheath may also be multi-lumen to facilitate the delivery of drugs or other devices.

本发明的球囊保护伞套件可以用于颈动脉血管及其他任何需要进行过滤保护的血管辅助治疗。The balloon protection umbrella kit of the present invention can be used for auxiliary treatment of carotid arteries and any other blood vessels that require filtering protection.

【第二实施方式】[Second Embodiment]

图4表示本发明的另一种实施方式的球囊保护伞套件的结构示意图。图5a和图5b为图4中的球囊组件的两种实施例的结构示意图。Fig. 4 shows a schematic structural diagram of a balloon umbrella kit according to another embodiment of the present invention. Fig. 5a and Fig. 5b are structural schematic diagrams of two embodiments of the balloon assembly in Fig. 4 .

如图4和图5a、图5b所示，在本实施方式中，球囊保护伞套件的结构与第一实施方式中的大致相同，其区别在于球囊组件的结构设计。As shown in Fig. 4 and Fig. 5a, Fig. 5b, in this embodiment, the structure of the balloon umbrella kit is substantially the same as that in the first embodiment, the difference lies in the structural design of the balloon assembly.

在本实施方式中，球囊组件的第一鞘管1包括内层鞘管13和套在内层鞘管13外的外层鞘管12，内层鞘管13与外层鞘管12彼此沿轴向能够相对移动，球囊2的一端与内层鞘管13连接，球囊的另一端与外层鞘管12连接，通过控制内层鞘管13与外层鞘管12之间的相对移动以控制球囊的膨胀和收缩。例如，球囊2可以是覆膜支架，包括支架21以及覆盖在支架21外的薄膜22。支架21可以由至少一根编织丝编织而成，也可以通过激光切割金属管而形成。薄膜22可以是硅胶、聚乙烯或聚丙烯等。In this embodiment, the first sheath tube 1 of the balloon assembly includes an inner sheath tube 13 and an outer sheath tube 12 sleeved outside the inner sheath tube 13, and the inner sheath tube 13 and the outer sheath tube 12 are along the The axial direction can be relatively moved, one end of the balloon 2 is connected with the inner sheath tube 13, and the other end of the balloon is connected with the outer layer sheath tube 12, by controlling the relative movement between the inner layer sheath tube 13 and the outer layer sheath tube 12 To control the inflation and deflation of the balloon. For example, the balloon 2 may be a covered stent, including a stent 21 and a thin film 22 covering the stent 21 . The stent 21 can be braided by at least one braided wire, or can be formed by laser cutting a metal tube. The film 22 can be made of silica gel, polyethylene or polypropylene, etc.

如图5a和图5b所示，可以是球囊的近端与内层鞘管13连接，球囊的远端与外层鞘管12连接；也可以是球囊的远端与内层鞘管13连接，球囊的近端与外层鞘管12连接。球囊的端部可以通过热熔粘接与内、外层鞘管相固定，或者通过其他胶粘等方式与内、外层鞘管相固定。As shown in Figures 5a and 5b, the proximal end of the balloon may be connected to the inner sheath 13, and the distal end of the balloon may be connected to the outer sheath 12; it may also be that the distal end of the balloon is connected to the inner sheath 13, the proximal end of the balloon is connected with the outer sheath tube 12. The end of the balloon can be fixed with the inner and outer sheaths by hot-melt bonding, or fixed with the inner and outer sheaths by other means such as gluing.

【第三实施方式】[Third Embodiment]

图6表示本发明的又一种实施方式的球囊保护伞套件的结构示意图。如图6所示，在本实施方式中，球囊保护伞套件的结构与第一实施方式和第二实施方式中的大致相同，其区别在于保护伞的数量。Fig. 6 shows a schematic structural view of a balloon umbrella kit according to another embodiment of the present invention. As shown in FIG. 6 , in this embodiment, the structure of the balloon protection umbrella set is substantially the same as that in the first embodiment and the second embodiment, the difference lies in the number of protection umbrellas.

在本实施方式中，保护伞的数量可以为两个(如图6中的保护伞4和4’)，以更好地防止斑块经过。此时，两个保护伞之间的间距为30～80mm，优选为40mm。两个保护伞的直径可以相同也可以不同，直径不同时，直径较大的保护伞4与球囊之间的距离更小。In this embodiment, the number of protective umbrellas can be two (such as protective umbrellas 4 and 4' in Figure 6), so as to better prevent plaques from passing through. At this time, the distance between the two protective umbrellas is 30-80 mm, preferably 40 mm. The diameters of the two protective umbrellas can be the same or different. When the diameters are different, the distance between the larger diameter protective umbrella 4 and the balloon is smaller.

可选地，保护伞也可以是3个或者更多个。Optionally, there can be 3 or more protective umbrellas.

本发明说明书中使用的术语和措辞仅仅为了举例说明，并不意味构成限定。本领域技术人员应当理解，在不脱离所公开的实施方式的基本原理的前提下，对上述实施方式中的各细节可进行各种变化。因此，本发明的保护范围只由权利要求确定，在权利要求中，除非另有说明，所有的术语应按最宽泛合理的意思进行理解。The terms and expressions used in the description of the present invention are for the purpose of illustration only and are not meant to be limiting. Those skilled in the art will understand that various changes may be made to the details of the above-described embodiments without departing from the basic principles of the disclosed embodiments. Therefore, the protection scope of the present invention is determined only by the claims, and in the claims, unless otherwise stated, all terms should be interpreted in the broadest and reasonable sense.