技术领域Technical field
本发明涉及医疗器械技术领域，特别涉及一种扩张后不完全阻断血流的球囊导管。The present invention relates to the technical field of medical devices, and in particular to a balloon catheter that does not completely block blood flow after expansion.
背景技术Background technique
球囊扩张术是介入治疗手术领域中一项重要的技术手段，已经从心脏拓展到颅内、外周等血管的治疗。球囊的应用场景也从单纯的球囊扩张、扩张支架拓展到了药物球囊和装载瓣膜等。不管是单纯的球囊扩张，还是扩张支架、装载瓣膜或药物球囊，都会在球囊扩张时会完全阻断血流通过。球囊阻断血流的时间如果太长，会造成下游的组织缺血，给病人带来风险。因此，在临床上，球囊扩张的时间需要控制在1分钟以内。Balloon dilatation is an important technical method in the field of interventional surgery, and has expanded from the heart to the treatment of intracranial and peripheral blood vessels. The application scenarios of balloons have also expanded from simple balloon expansion and stent expansion to drug balloons and loaded valves. Whether it is a simple balloon dilation, expansion of a stent, a loaded valve, or a drug-filled balloon, blood flow will be completely blocked when the balloon is inflated. If the balloon blocks blood flow for too long, it can cause ischemia in downstream tissues and put the patient at risk. Therefore, clinically, the balloon expansion time needs to be controlled within 1 minute.
以药物球囊为例，以上时间限制特别影响药物球囊的药物释放，降低了药物在血管表面的粘附效率，也减少了血管表面的有效药物含量，最终影响了狭窄病变的治疗。而且即便目前存在一些不完全阻挡血流的球囊导管，但是这些球囊导管使用时，不接触血管壁的部分无法释放药物，导致整个病变血管表面的有些部位没有药物，使药物不能够充足充分地作用于病变血管，影响了狭窄病变的治疗。Taking the drug balloon as an example, the above time limit particularly affects the drug release of the drug balloon, reduces the adhesion efficiency of the drug on the blood vessel surface, and also reduces the effective drug content on the blood vessel surface, ultimately affecting the treatment of stenotic lesions. And even though there are currently some balloon catheters that do not completely block blood flow, when these balloon catheters are used, the parts that do not contact the blood vessel wall cannot release drugs, resulting in some parts of the entire diseased blood vessel surface being without drugs, making the drugs insufficient. It acts on diseased blood vessels and affects the treatment of stenotic lesions.
发明内容Contents of the invention
本发明的目的在于提供一种球囊导管，以解决现有技术中的球囊导管所存在的至少一个技术问题。The object of the present invention is to provide a balloon catheter to solve at least one technical problem existing in balloon catheters in the prior art.
为实现上述目的，本发明提供一种球囊导管，其包括管体和多个球囊体，所述多个球囊体沿所述管体的轴向依次设置在所述管体的远端；每个所述球囊体具有收缩状态和扩张状态，并能够在所述收缩状态和所述扩张状态之间切换；每个所述球囊体的一部分外表面在所述扩张状态时形成为允许血流通过的第一构造，另一部分外表面在所述扩张状态时形成为能够与目标腔壁贴靠的第二构造，且相邻两个所述球囊体上的所述第一构造在所述管体的周向上错开。In order to achieve the above object, the present invention provides a balloon catheter, which includes a tube body and a plurality of balloon bodies, and the plurality of balloon bodies are sequentially arranged at the distal end of the tube body along the axial direction of the tube body. ; Each of the balloon bodies has a contracted state and an expanded state, and can be switched between the contracted state and the expanded state; a part of the outer surface of each of the balloon bodies is formed in the expanded state as The first structure allows blood flow to pass through, and the other part of the outer surface is formed into a second structure that can abut against the target cavity wall in the expanded state, and the first structure on two adjacent balloon bodies staggered in the circumferential direction of the tube body.
在一实施方式中，每个所述球囊体在所述扩张状态时具有均匀或不均匀的外径。In one embodiment, each of the balloon bodies has a uniform or non-uniform outer diameter in the expanded state.
在一实施方式中，每个所述球囊体在所述扩张状态时的横截面形状为对称图形或非对称图形。In one embodiment, the cross-sectional shape of each balloon body in the expanded state is a symmetrical pattern or an asymmetrical pattern.
在一实施方式中，每个所述球囊体在所述扩张状态时的横截面形状为以下特征中的一种：8字形；花瓣形；半圆形；椭圆形；长腰圆形；矩形和半圆形相结合的第一组合；以及半圆形、三角形和矩形相结合的第二组合。In one embodiment, the cross-sectional shape of each balloon body in the expanded state is one of the following characteristics: figure-8; petal-shaped; semicircle; oval; long-waisted circle; rectangle The first combination with a semicircle; and the second combination with a semicircle, triangle and rectangle.
在一实施方式中，每个所述球囊体在所述扩张状态时的整个外表面无凹陷，或者，每个所述球囊体在所述扩张状态时的一部分外表面向内凹陷。In one embodiment, the entire outer surface of each balloon body in the expanded state is free of depressions, or a portion of the outer surface of each balloon body in the expanded state is depressed inward.
在一实施方式中，每个所述球囊体的外表面在所述扩张状态时形成有多个所述第一构造，每个所述球囊体上的所有所述第一构造沿所述管体的周向依次均匀或不均匀地设置。In one embodiment, the outer surface of each balloon body is formed with a plurality of first structures in the expanded state, and all the first structures on each balloon body are formed along the The circumferential direction of the tube body is arranged uniformly or unevenly in sequence.
在一实施方式中，所有所述球囊体上的所述第二构造沿所述管体的周向依次均匀或不均匀地设置。In one embodiment, the second structures on all the balloon bodies are arranged uniformly or unevenly in sequence along the circumferential direction of the tube body.
在一实施方式中，每个所述球囊体的外表面在所述扩张状态时由圆弧面组成，或者外表面由圆弧面和平面组成。In one embodiment, the outer surface of each balloon body is composed of an arc surface in the expanded state, or the outer surface is composed of an arc surface and a flat surface.
在一实施方式中，多个所述球囊体一体成型制作，或者，多个所述球囊体分开制作，或者，所述球囊体由多个球囊拼接而成。In one embodiment, a plurality of the balloon bodies are integrally molded and manufactured, or a plurality of the balloon bodies are manufactured separately, or the balloon body is spliced from a plurality of balloons.
在一实施方式中，在所述扩张状态时，所述球囊体的所述一部分外表面被所述另一部分外表面所包绕在内部，或者，在所述扩张状态时，所述球囊体的所述一部分外表面与所述另一部分外表面沿周向不重叠。In one embodiment, in the expanded state, the part of the outer surface of the balloon body is surrounded by the other part of the outer surface, or, in the expanded state, the balloon body The part of the outer surface of the body does not circumferentially overlap with the other part of the outer surface.
在一实施方式中，所述球囊导管还包括药物涂层，所述药物涂层设置在所述第二构造上。In one embodiment, the balloon catheter further includes a drug coating disposed on the second configuration.
在一实施方式中，所述球囊导管包括结构相同或不相同的所述多个球囊体。In one embodiment, the balloon catheter includes a plurality of balloon bodies with the same or different structures.
在一实施方式中，所述管体具有沿自身轴向贯通地延伸的多个通液腔，所述通液腔与所述球囊体一一对应地连通多个所述通液腔用以控制各个所述球囊体相互独立地收缩或扩张，或者，所述管体具有沿自身轴向贯通地延伸的一个通液腔，所述通液腔连通所有所述球囊体，以控制所有所述球囊体同时收缩或扩张。In one embodiment, the tube body has a plurality of liquid-passing cavities extending penetratingly along its own axial direction, and the liquid-passing cavities communicate with the balloon body in a one-to-one correspondence. Control each of the balloon bodies to contract or expand independently of each other, or the tube body has a liquid-passing cavity extending through its axis, and the liquid-passing cavity communicates with all the balloon bodies to control all the balloon bodies. The balloon body contracts or expands at the same time.
在一实施方式中，当所述通液腔的数量为多个时，所述管体为单层的多腔管，所述单层管的管壁中设置有相互独立的多个所述通液腔，或者，所述管体为多层管，在相邻两层管材之间设置有至少一个所述通液腔。In one embodiment, when there are multiple liquid-passing chambers, the tube body is a single-layer multi-lumen tube, and a plurality of independent through-flow chambers are provided in the wall of the single-layer tube. Liquid cavity, or the pipe body is a multi-layer pipe, and at least one liquid-passing cavity is provided between two adjacent layers of pipes.
在本发明提供的球囊导管中，包括：管体和多个球囊体，所述多个球囊体沿所述管体的轴向依次设置在所述管体的远端；每个所述球囊体具有收缩状态和扩张状态，并能够在所述收缩状态和所述扩张状态之间切换；每个所述球囊体的一部分外表面在所述扩张状态时形成为允许血流通过的第一构造，另一部分外表面在所述扩张状态时形成为能够与目标腔壁贴靠的第二构造，且相邻两个所述球囊体上的所述第一构造在所述管体的周向上错开。The balloon catheter provided by the present invention includes: a tube body and a plurality of balloon bodies, the plurality of balloon bodies are sequentially arranged at the distal end of the tube body along the axial direction of the tube body; each The balloon body has a contracted state and an expanded state, and can be switched between the contracted state and the expanded state; a part of the outer surface of each balloon body is formed to allow blood flow to pass through in the expanded state. the first structure, the other part of the outer surface is formed into a second structure that can abut against the target cavity wall in the expansion state, and the first structure on the two adjacent balloon bodies is in the tube. The circumference of the body is staggered upward.
如此配置时，即便球囊体扩张，也可借助于球囊体上的第一构造来通过血流，保证球囊体扩张时血流的畅通，避免造成下游的组织缺血，降低手术风险，而且球囊体扩张的时间可以更长，延长的时间可以确保球囊体上的药物充分释放至血管表面，增加药物在血管表面的释放率，从而改善狭窄病变的治疗效果。不仅如此，在球囊体扩张时，可以通过多个球囊体的先后扩张，实现整个病变血管表面都粘附有药物，使药物充足且充分地粘附在血管壁上，确保整个病变血管表面的药物粘附量，以此进一步改善狭窄病变的治疗效果。其次，可通过多个球囊体进行多次给药，或者根据病变位置的长度选择需扩张的球囊体的数量，使同一套球囊导管能够实现多次给药或者一次性应对更长狭窄病变的治疗，不仅可以有效地增加药物粘附在血管壁或组织上的释放量，而且球囊导管的使用更为灵活和方便，应用范围更广。When configured in this way, even if the balloon body is expanded, the first structure on the balloon body can be used to pass the blood flow, ensuring smooth blood flow when the balloon body is expanded, avoiding ischemia of downstream tissues, and reducing surgical risks. Moreover, the balloon can be expanded for a longer time. The extended time can ensure that the drug on the balloon is fully released to the blood vessel surface and increase the release rate of the drug on the blood vessel surface, thereby improving the therapeutic effect of stenotic lesions. Not only that, when the balloon is expanded, the drug can be adhered to the entire diseased blood vessel surface through the sequential expansion of multiple balloons, so that the drug can fully and fully adhere to the blood vessel wall, ensuring that the entire diseased blood vessel surface is The amount of drug adhesion can further improve the therapeutic effect of stenotic lesions. Secondly, multiple administrations can be carried out through multiple balloons, or the number of balloons to be expanded can be selected according to the length of the lesion, so that the same set of balloon catheters can achieve multiple administrations or handle longer stenosis at one time The treatment of lesions can not only effectively increase the release of drugs adhered to the blood vessel wall or tissue, but also makes the use of balloon catheters more flexible and convenient, with a wider range of applications.
附图说明Description of drawings
本领域的普通技术人员将会理解，提供的附图用于更好地理解本发明，而不对本发明的范围构成任何限定。其中：Those of ordinary skill in the art will understand that the drawings are provided for a better understanding of the invention and do not constitute any limitation on the scope of the invention. in:
图1为本发明根据优选实施例提供的球囊导管的立体结构示意图；Figure 1 is a schematic three-dimensional structural diagram of a balloon catheter provided according to a preferred embodiment of the present invention;
图2为本发明根据优选实施例提供的球囊导管的纵向剖面图；Figure 2 is a longitudinal cross-sectional view of a balloon catheter provided according to a preferred embodiment of the present invention;
图3至图11分别为本发明根据优选实施例提供的球囊体扩张后的横截面的结构示意图；Figures 3 to 11 are respectively schematic structural diagrams of the cross-section of the balloon body after expansion according to the preferred embodiment of the present invention;
图12为本发明根据优选实施例提供的相邻两个球囊体垂直交错的横截面的布置示意图；Figure 12 is a schematic layout diagram of vertically staggered cross-sections of two adjacent balloon bodies provided according to a preferred embodiment of the present invention;
图13至图16分别为本发明根据优选实施例提供的管体的横向剖面图；Figures 13 to 16 are respectively transverse cross-sectional views of the pipe body provided according to the preferred embodiment of the present invention;
图17为本发明根据优选实施例提供的球囊导管中两个球囊体先后扩张的原理图。Figure 17 is a schematic diagram of two balloon bodies in the balloon catheter provided according to the preferred embodiment of the present invention.
[附图中的标号说明如下]：[The numbers in the attached drawings are explained as follows]:
10-球囊导管；11-管体；111-第一通液腔；112-第二通液腔；113-出口；12-第一球囊体；13-第二球囊体；14-凹槽；101-8字形；102-优弧形；103-半圆形；104-椭圆形；105-花瓣形；106-长腰圆形；107-第一组合；108-第二组合；109-外圆；110-内圆；20-输送鞘管。10-balloon catheter; 11-tube body; 111-first liquid-passing chamber; 112-second liquid-passing chamber; 113-outlet; 12-first balloon body; 13-second balloon body; 14-concave Groove; 101-8-shaped; 102-excellent arc; 103-semi-circular; 104-oval; 105-petal-shaped; 106-long-waisted round; 107-first combination; 108-second combination; 109- Outer circle; 110-inner circle; 20-delivery sheath.
具体实施方式Detailed ways
为使本发明的目的、优点和特征更加清楚，以下结合附图和具体实施例对本发明作进一步详细说明。需说明的是，附图均采用非常简化的形式且未按比例绘制，仅用以方便、明晰地辅助说明本发明实施例的目的。此外，附图所展示的结构往往是实际结构的一部分。特别的，各附图需要展示的侧重点不同，有时会采用不同的比例。In order to make the purpose, advantages and features of the present invention clearer, the present invention will be further described in detail below with reference to the accompanying drawings and specific embodiments. It should be noted that the drawings are in a very simplified form and are not drawn to scale, and are only used to conveniently and clearly assist in explaining the embodiments of the present invention. In addition, the structures shown in the drawings are often part of the actual structure. In particular, each drawing needs to display different emphasis, and sometimes uses different proportions.
如在本发明中所使用的，单数形式“一”、“一个”以及“该”包括复数对象，术语“或”通常是以包括“和/或”的含义而进行使用的，术语“若干”通常是以包括“至少一个”的含义而进行使用的，术语“至少两个”通常是以包括“两个或两个以上”的含义而进行使用的，此外，术语“第一”、“第二”仅用于描述目的，而不能理解为指示或暗示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一个或者至少两个该特征，“一端”与“另一端”以及“近端”与“远端”通常是指相对应的两部分，其不仅包括端点。此外，如在本发明中所使用的，“安装”、“相连”、“连接”，一元件“设置”于另一元件，应做广义理解，通常仅表示两元件之间存在连接、耦合、配合或传动关系，且两元件之间可以是直接的或通过中间元件间接的连接、耦合、配合或传动，而不能理解为指示或暗示两元件之间的空间位置关系，即一元件可以在另一元件的内部、外部、上方、下方或一侧等任意方位，除非内容另外明确指出外。对于本领域的普通技术人员而言，可以根据具体情况理解上述术语在本发明中的具体含义。此外，诸如上方、下方、上、下、向上、向下、左、右等的方向术语相对于示例性实施方案如它们在图中所示进行使用，向上或上方向朝向对应附图的顶部，向下或下方向朝向对应附图的底部。本文中，“近端”通常是指靠近球囊导管操作者的一端，“远端”与“近端”相对，是指远离球囊导管操作者的一端。本文中，“轴向”是指平行于球囊导管的纵向轴线的方向；“周向”是指围绕球囊导管的纵向轴线的方向：“横截面”是指垂直于球囊导管的纵向轴线的截面。As used in this invention, the singular forms "a", "an" and "the" include plural referents, the term "or" is generally used in its sense including "and/or", and the term "several" The term "at least two" is usually used in a meaning including "at least one", and the term "at least two" is usually used in a meaning including "two or more". In addition, the terms "first" and "th "two" is for descriptive purposes only and cannot be understood as indicating or implying the relative importance or implicitly indicating the quantity of the technical features indicated. Therefore, the features defined as "first" and "second" may explicitly or implicitly include one or at least two of the features, "one end" and "another end" and "proximal end" and "distant end" are generally refers to the two corresponding parts, which not only include the endpoints. In addition, as used in the present invention, "mounted", "connected", "connected", one element is "disposed" on another element, should be interpreted broadly, and usually only mean that there is a connection, coupling, or connection between the two elements. Cooperation or transmission relationship, and the connection, coupling, cooperation or transmission between the two elements can be direct or indirect through an intermediate element, and it cannot be understood as indicating or implying the spatial positional relationship between the two elements, that is, one element can be in another Any orientation inside, outside, above, below, or to one side of a component, unless the content clearly indicates otherwise. For those of ordinary skill in the art, the specific meanings of the above terms in the present invention can be understood according to specific circumstances. Furthermore, directional terms such as above, below, up, down, up, down, left, right, etc. are used with respect to the exemplary embodiments as they are shown in the figures, with the upward or upward direction being toward the top of the corresponding figure, The downward or downward direction is towards the bottom of the corresponding figure. In this article, the "proximal end" usually refers to the end close to the balloon catheter operator, and the "distal end" is opposite to the "proximal end" and refers to the end far away from the balloon catheter operator. As used herein, “axial” refers to a direction parallel to the longitudinal axis of the balloon catheter; “circumferential” refers to a direction about the longitudinal axis of the balloon catheter; and “cross-sectional” refers to a direction perpendicular to the longitudinal axis of the balloon catheter. cross section.
本发明公开了一种球囊导管，适用于球囊扩张狭窄的场合，特别适用于药物球囊贴合狭窄病变的场合。当球囊导管为药物球囊导管时，球囊的外表面涂覆具有治疗作用的药物，当球囊到达血管内的病变部位后，球囊通过扩张使其表面的药物与血管壁接触，药物释放并作用病变部位，从而达到治疗预防血管内再狭窄的目的。本发明对药物的种类不作限定。The invention discloses a balloon catheter, which is suitable for situations where a balloon expands stenosis, and is particularly suitable for situations where a drug balloon fits stenotic lesions. When the balloon catheter is a drug balloon catheter, the outer surface of the balloon is coated with a therapeutic drug. When the balloon reaches the lesion in the blood vessel, the balloon expands so that the drug on the surface comes into contact with the blood vessel wall, and the drug Release and act on the lesion, thereby achieving the purpose of treating and preventing intravascular restenosis. The present invention does not limit the type of medicine.
与现有技术相比，本发明公开的球囊导管不完全阻挡血流，使得球囊扩张的时间可以更长，从而改善狭窄病变的治疗效果。而且本发明公开的球囊导管在球囊扩张时，可以实现整个病变血管表面都粘附有药物，使药物充足且充分地粘附在血管壁上，确保整个病变血管表面的药物粘附量，以此进一步改善狭窄病变的治疗效果。如此设置，本发明克服了传统不完全阻挡血流的球囊导管无法使整个病变血管表面粘附药物的缺陷。不仅如此，本发明还可使同一个球囊导管进行多次给药或者一次性应对更长狭窄病变的治疗，而无需多次植入球囊导管，降低了手术难度，也降低了对患者的伤害，使球囊导管的使用更为灵活和方便，应用范围更广。Compared with the prior art, the balloon catheter disclosed in the present invention does not completely block the blood flow, so that the balloon expansion time can be longer, thereby improving the therapeutic effect of stenotic lesions. Moreover, when the balloon catheter disclosed in the present invention is expanded, the drug can be adhered to the entire surface of the diseased blood vessel, so that the drug can fully and fully adhere to the blood vessel wall, ensuring the amount of drug adhesion on the entire surface of the diseased blood vessel. This can further improve the therapeutic effect of stenotic lesions. With this arrangement, the present invention overcomes the defect of traditional balloon catheters that do not completely block blood flow and cannot adhere drugs to the entire surface of diseased blood vessels. Not only that, the present invention can also enable the same balloon catheter to perform multiple administrations or treat longer stenotic lesions at one time without the need to implant balloon catheters multiple times, which reduces the difficulty of the operation and reduces the burden on the patient. injury, making the use of balloon catheters more flexible and convenient, with a wider range of applications.
以下参考附图进行描述，且在不冲突的情况下，下述的实施方式及实施方式中的特征可以相互补充或相互组合。在以下描述中，以两个球囊体为示意来说明本发明的球囊导管的结构及其使用方式，但以下说明不作为对本发明的限定，如本领域技术人员可以理解，在其他情况下，球囊体的数量还可以是三个或更多个，且其他数目的球囊体的实施方式与两个球囊体的实施方式基本相同，因此，本领域技术人员应当能够修改以下描述将其应用于更多球囊体的情况。The following description is made with reference to the accompanying drawings, and the following embodiments and features in the embodiments may complement or be combined with each other unless they conflict. In the following description, two balloon bodies are used as a schematic to illustrate the structure and usage of the balloon catheter of the present invention. However, the following description is not intended to limit the present invention. As those skilled in the art can understand, in other cases , the number of balloon bodies can also be three or more, and the implementation of other numbers of balloon bodies is basically the same as the implementation of two balloon bodies. Therefore, those skilled in the art should be able to modify the following description. It is used for more balloon cases.
图1和图2示出了本发明所涉及的球囊导管10的一个具体实施例。如图1和图2所示，本发明提供的球囊导管10包括管体11以及设置于管体11远端的第一球囊体12和第二球囊体13。第一球囊体12和第二球囊体13沿管体11的轴向从远端至近端依次设置，即，第一球囊体12设置在第二球囊体13的远端。第一球囊体12和第二球囊体13可以轴向间隔一定距离设置，也可以彼此首尾紧挨着。第一球囊体12和第二球囊体13最好是紧挨着彼此，以减小球囊导管10的轴向长度，减小输送系统的尺寸。Figures 1 and 2 show a specific embodiment of the balloon catheter 10 involved in the present invention. As shown in FIGS. 1 and 2 , the balloon catheter 10 provided by the present invention includes a tube body 11 and a first balloon body 12 and a second balloon body 13 disposed at the distal end of the tube body 11 . The first balloon body 12 and the second balloon body 13 are arranged in sequence from the distal end to the proximal end along the axial direction of the tube body 11 , that is, the first balloon body 12 is arranged at the distal end of the second balloon body 13 . The first balloon body 12 and the second balloon body 13 may be arranged at a certain distance in the axial direction, or may be adjacent to each other end to end. The first balloon body 12 and the second balloon body 13 are preferably positioned immediately adjacent to each other to reduce the axial length of the balloon catheter 10 and reduce the size of the delivery system.
参见图17，所述输送系统包括输送鞘管20，用于装载球囊导管10，以将球囊导管10递送至体内目标位置。Referring to Figure 17, the delivery system includes a delivery sheath 20 for loading the balloon catheter 10 to deliver the balloon catheter 10 to a target location in the body.
所述第一球囊体12和第二球囊体13均具有收缩状态和扩张状态，并能够在所述收缩状态和所述扩张状态之间切换。所述收缩状态是指球囊体未充盈时的状态，即卸压状态；所述扩张状态是指球囊体充盈时的状态，即增压状态。在一些实施例中，所述第一球囊体12和第二球囊体13可以相互独立地收缩或扩张，两者互不影响；在另一些实施例，所述第一球囊体12和第二球囊体13可以同时收缩和扩张。实践中，两个球囊体可以由一个球囊一次成型制作，即可通过一个球囊制备两个球囊体，或者，两个球囊体可以由不同的球囊制作形成。此外，任意一个球囊体可以是一个连续的球囊，也可以由多个球囊拼接而成。换言之，制作两个独立或同时收缩或扩张的球囊体的方式可以有多种，本发明对此不限定。The first balloon body 12 and the second balloon body 13 both have a contracted state and an expanded state, and can be switched between the contracted state and the expanded state. The contracted state refers to the state when the balloon body is not inflated, that is, the pressure relief state; the expanded state refers to the state when the balloon body is filled, that is, the pressurized state. In some embodiments, the first balloon body 12 and the second balloon body 13 can contract or expand independently of each other without affecting each other; in other embodiments, the first balloon body 12 and the second balloon body 13 can contract or expand independently of each other. The second balloon body 13 can be contracted and expanded at the same time. In practice, two balloon bodies can be formed by one balloon at one time, that is, two balloon bodies can be prepared by one balloon, or the two balloon bodies can be formed by different balloons. In addition, any balloon body can be a continuous balloon or can be made up of multiple balloons. In other words, there are many ways to make two balloons that can shrink or expand independently or simultaneously, and the present invention is not limited to this.
所述管体11具有沿自身轴向贯通地延伸的多个通液腔，所述通液腔与所述球囊体一一对应地连通，多个所述通液腔用以控制各个球囊体相互独立地收缩或扩张。在其他一些实施例中，所述管体11具有沿自身轴向贯通地延伸的一个通液腔，该所述通液腔连通所有球囊体，以时控制所有所述球囊体同时收缩或扩张。The tube body 11 has a plurality of liquid-passing cavities that extend penetratingly along its own axial direction. The liquid-passing cavities communicate with the balloon body in a one-to-one correspondence. The plurality of liquid-passing cavities are used to control each balloon. The bodies contract or expand independently of each other. In some other embodiments, the tube body 11 has a liquid-passing cavity extending through its axis, and the liquid-passing cavity communicates with all balloon bodies to control all balloon bodies to contract simultaneously or expansion.
参阅图2，在本发明实施例中，所述管体11具有沿自身轴向贯通地延伸的第一通液腔111和第二通液腔112。所述第一通液腔111和第二通液腔112并排地设置在管体11的内部，两者互不连通。所述第一通液腔111和第二通液腔112的远端均设置有至少一个出口113；所述第一通液腔111中远端的至少一个出口113与第一球囊体12的内腔连通；所述第二通液腔112中远端的至少一个出口113与第二球囊体13的内腔连通；并经由第一通液腔111和其远端出口113向第一球囊体12灌注充盈介质，使第一球囊体12充盈扩张；并经由第二通液腔112和其远端出口113向第二球囊体13灌注充盈介质，使第二球囊体13充盈扩张。所述充盈介质的种类不限制，例如为造影剂。Referring to FIG. 2 , in the embodiment of the present invention, the tube body 11 has a first liquid-passing chamber 111 and a second liquid-passing chamber 112 extending penetratingly along its own axial direction. The first liquid-passing chamber 111 and the second liquid-passing chamber 112 are arranged side by side inside the tube body 11 and are not connected to each other. The distal ends of the first liquid-passing chamber 111 and the second liquid-passing chamber 112 are each provided with at least one outlet 113; The inner cavity is connected; at least one outlet 113 at the distal end of the second liquid-passing chamber 112 is connected with the inner cavity of the second balloon body 13; and through the first liquid-passing chamber 111 and its distal outlet 113, the first balloon The balloon body 12 is filled with filling medium to inflate the first balloon body 12; and the filling medium is poured into the second balloon body 13 through the second liquid chamber 112 and its distal outlet 113 to inflate the second balloon body 13. expansion. The type of the filling medium is not limited, for example, it is a contrast medium.
为了解决现有技术中的球囊导管完全阻挡血流的问题，本发明所提供的球囊导管10被配置为，每个所述球囊体的一部分外表面在所述扩张状态时形成为允许血流通过的第一构造，另一部分外表面在所述扩张状态时形成为能够与血管壁(即目标腔壁)贴靠的第二构造。这里的第一构造和第二构造主要包括球囊体于扩张状态时的形状和/或尺寸。第一构造使球囊体的外表面与血管壁之间形成血流通道，第二构造使球囊体的外表面能够接触到血管壁。In order to solve the problem that balloon catheters in the prior art completely block blood flow, the balloon catheter 10 provided by the present invention is configured such that a part of the outer surface of each balloon body is formed to allow The first structure through which blood flow passes, and the other part of the outer surface is formed into a second structure capable of abutting against the blood vessel wall (ie, the target cavity wall) in the expanded state. The first structure and the second structure here mainly include the shape and/or size of the balloon body in the expanded state. The first structure enables a blood flow channel to be formed between the outer surface of the balloon body and the blood vessel wall, and the second structure enables the outer surface of the balloon body to contact the blood vessel wall.
具体地，第一球囊体12的一部分外表面在扩张时形成第一构造，另一部分外表面在扩张时形成第二构造，第一球囊体12的第一构造允许通过血流，第一球囊体12的第二构造可以贴靠血管壁，如贴靠血管壁后释放药物；同理，第二球囊体13的一部分外表面在扩张时形成第一构造，另一部分外表面在扩张时形成第二构造，第二球囊体13的第一构造允许通过血流，第二球囊体13的第二构造可以贴靠血管壁，如贴靠血管壁后释放药物。Specifically, a portion of the outer surface of the first balloon body 12 forms a first configuration when expanded, and another portion of the outer surface forms a second structure when expanded. The first structure of the first balloon body 12 allows blood flow, and the first The second structure of the balloon body 12 can be close to the blood vessel wall, for example, the drug can be released after being close to the blood vessel wall; similarly, a part of the outer surface of the second balloon body 13 forms the first structure when expanded, and the other part of the outer surface is expanded. When the second structure is formed, the first structure of the second balloon body 13 allows blood flow, and the second structure of the second balloon body 13 can abut against the blood vessel wall, for example, the drug can be released after abutting against the blood vessel wall.
为了进一步地解决现有技术中的球囊导管在不完全阻挡血流的同时还会影响药物在整个病变血管表面粘附的问题，因为在治疗过程中，球囊体扩张的形状可能会受病变位置的影响，即使球囊体自然扩张后外表面在周向上会闭合，但是在狭窄部位扩张，可能存在无法完全闭合的风险，此时，不完全闭合的外表面不能沿病变血管周向一整圈释放药物，因此，本发明所提供的球囊导管10还被配置为，至少相邻两个所述球囊体上的所述第一构造在所述管体11的周向上错开。所述“周向上错开”指的是，在垂直于所述管体11的纵向轴线的同一个投影平面上，一个球囊体上的所述第一构造的投影和另一个球囊体上的所述第一构造的投影是不重叠的，不重叠可以部分不重叠或者全部不重叠。这样设置后，在血流通过球囊体与血管之间的空间时，球囊导管10有充足的外表面来贴靠整个血管壁一圈，使药物充足且充分地粘附在整个病变血管的表面。还应理解，相邻两个球囊体的第一构造在管体的周向上错开时，第二构造同样在管体的周向上错开，使周向错开的第二构造沿整个血管周向分布。In order to further solve the problem that the balloon catheter in the prior art does not completely block the blood flow but also affects the adhesion of the drug on the entire diseased blood vessel surface, because during the treatment process, the expanded shape of the balloon may be affected by the disease. Due to the influence of position, even if the outer surface of the balloon will be closed circumferentially after natural expansion, there may be a risk of incomplete closure when expanded at the stenosis site. At this time, the incompletely closed outer surface cannot be completely closed along the circumference of the diseased vessel. The loop releases the drug. Therefore, the balloon catheter 10 provided by the present invention is also configured such that the first structures on at least two adjacent balloon bodies are staggered in the circumferential direction of the tube body 11 . The "circumferential offset" means that on the same projection plane perpendicular to the longitudinal axis of the tube body 11, the projection of the first structure on one balloon body and the projection of the first structure on the other balloon body The projections of the first structure are non-overlapping, and the non-overlapping may be partially non-overlapping or completely non-overlapping. After being set up in this way, when blood flows through the space between the balloon body and the blood vessel, the balloon catheter 10 has sufficient outer surface to abut the entire blood vessel wall, allowing the drug to fully and fully adhere to the entire diseased blood vessel. surface. It should also be understood that when the first structures of two adjacent balloon bodies are staggered in the circumferential direction of the tube body, the second structures are also staggered in the circumferential direction of the tube body, so that the circumferentially staggered second structures are distributed along the entire blood vessel circumference. .
参阅图1，在本发明实施例中，所述第一球囊体12上的所述第一构造和所述第二球囊体13上的所述第一构造在管体11的周向上错开，所述第一构造如为凹槽14。Referring to Figure 1, in the embodiment of the present invention, the first structure on the first balloon body 12 and the first structure on the second balloon body 13 are staggered in the circumferential direction of the tube body 11 , the first structure is, for example, the groove 14 .
在一实施方式中，当输送系统将球囊导管10递送至体内目标狭窄位置后，首先使第二球囊体13保留在输送鞘管20(参见图17)中而处于收缩状态，此时，先扩张到位的第一球囊体12，第一球囊体12上的第二构造贴靠血管壁来释放药物，同时第一球囊体12上的第一构造则允许血液通过，一段时间后，卸载第一球囊体12，使第一球囊体12处于收缩状态，然后，再将球囊导管10往前推送，将第二球囊体13推送至目标狭窄位置后扩张第二球囊体13，第二球囊体13上的第二构造贴靠血管壁来释放药物，同时第二球囊体13的第一构造则允许血液通过，经过一段时间后，卸载第二球囊体13，最后撤出整根球囊导管10，即完成同一个狭窄病变位置的治疗。该使用方式中，当球囊导管10输送到位后，操作者可重复扩张球囊体，进行多次给药，使各个球囊体上的药物贴附在病变血管圆周上的不同位置，使整个病变血管的表面都能粘附上药物。如此，通过两个球囊体先后扩张释放药物，解决了因单个球囊体的部分外表面无法与血管壁贴靠导致整个血管表面不能全粘附药物的问题，从而实现了药物充足充分地释放到血管表面，保证了血管表面的药物释放量，进一步改善了狭窄病变的治疗效果。然而，在其他实施方式中，所述两个球囊体也可以同时扩张或收缩，这里的同时扩张指的是两个球囊体同时处于扩张状态来治疗狭窄病变，一般情况下，该使用方式适用于治疗更长的狭窄病变。但是需理解的是，所有球囊体同时扩张或收缩并没有特指所有球囊体与同一个通液腔连通，当然也存在各个球囊体各自连通一个通液腔的情况。In one embodiment, after the delivery system delivers the balloon catheter 10 to the target stenosis position in the body, the second balloon body 13 is first retained in the delivery sheath 20 (see Figure 17) in a contracted state. At this time, The first balloon body 12 is first expanded into place. The second structure on the first balloon body 12 is pressed against the blood vessel wall to release the drug. At the same time, the first structure on the first balloon body 12 allows blood to pass. After a period of time, , unload the first balloon body 12 so that the first balloon body 12 is in a contracted state, then push the balloon catheter 10 forward, push the second balloon body 13 to the target stenosis position, and then expand the second balloon. body 13. The second structure on the second balloon body 13 presses against the blood vessel wall to release the drug. At the same time, the first structure of the second balloon body 13 allows blood to pass through. After a period of time, the second balloon body 13 is unloaded. , and finally the entire balloon catheter 10 is withdrawn, that is, the treatment of the same stenotic lesion location is completed. In this usage method, after the balloon catheter 10 is delivered in place, the operator can repeatedly expand the balloon body and perform multiple administrations, so that the medicine on each balloon body is attached to different positions on the circumference of the diseased blood vessel, so that the entire Drugs can adhere to the surface of diseased blood vessels. In this way, the drug is released by successive expansion of the two balloons, which solves the problem that the drug cannot fully adhere to the entire blood vessel surface due to the inability of part of the outer surface of a single balloon to adhere to the blood vessel wall, thereby achieving sufficient drug release. to the blood vessel surface, ensuring drug release on the blood vessel surface, further improving the therapeutic effect of stenotic lesions. However, in other embodiments, the two balloons can also be expanded or contracted at the same time. Simultaneous expansion here means that the two balloons are in an expanded state at the same time to treat stenotic lesions. Generally, this usage method Suitable for treating longer stenotic lesions. However, it should be understood that the simultaneous expansion or contraction of all balloon bodies does not specifically mean that all balloon bodies are connected to the same liquid-passing cavity. Of course, there are also situations where each balloon body is connected to a liquid-passing cavity.
在一具体示例中，形成所述第一构造和所述第二构造的方式为使所述球囊体在所述扩张状态时具有不均匀(即不相同)的外径。在其他示例中，形成所述第一构造和所述第二构造的方式为使所述球囊体在所述扩张状态时具有均匀(即相同)的外径。In a specific example, the first structure and the second structure are formed in such a manner that the balloon body has non-uniform (that is, different) outer diameters in the expanded state. In other examples, the first configuration and the second configuration are formed such that the balloon body has a uniform (ie, the same) outer diameter in the expanded state.
当球囊体扩张后的外径不相同时，使得球囊体的一部分外表面能够贴靠血管壁而形成所述第二构造，同时球囊体的另一部分外表面无法贴靠血管壁而形成所述第一构造，该情况下，通常球囊体的一部分外表面与另一部分外表面沿周向不重叠。When the outer diameters of the balloons are different after expansion, a part of the outer surface of the balloon can abut against the blood vessel wall to form the second structure, and at the same time, another part of the outer surface of the balloon cannot abut against the blood vessel wall. In the first configuration, in this case, usually a part of the outer surface of the balloon does not overlap with another part of the outer surface in the circumferential direction.
当球囊体扩张后的外径相同时，使得球囊体的一部分外表面能够贴靠血管壁一圈而形成所述第二构造，同时球囊体的另一部分外表面无法贴靠血管壁而形成所述第一构造，该情况下，通常球囊体的一部分外表面被另一部分外表面所包绕在内部。When the outer diameter of the balloon body is the same after expansion, a part of the outer surface of the balloon body can abut against the blood vessel wall to form the second structure. At the same time, another part of the outer surface of the balloon body cannot abut against the blood vessel wall. To form the first structure, in this case, a part of the outer surface of the balloon body is usually surrounded by another part of the outer surface.
但是每个所述球囊体扩张后的横截面形状可以是各种形状，如对称图形或非对称图形；所述对称图形包括轴对称图形及中心对称图形；所述非对称图形是除了对称图形以外的异形形状；此外，每个所述球囊体在所述扩张状态时的外表面可以完全由圆弧面组成，也可以由圆弧面和平面组成，具体不限定；另外，每个球囊体上的所述第一构造的数量可以是一个或多个，若为多个，多个第一构造沿管体11的周向依次均匀或不均匀地设置。However, the cross-sectional shape of each balloon body after expansion can be various shapes, such as symmetrical figures or asymmetrical figures; the symmetrical figures include axially symmetrical figures and centrally symmetrical figures; the asymmetrical figures are in addition to symmetrical figures Other special-shaped shapes; in addition, the outer surface of each balloon body in the expansion state can be completely composed of an arc surface, or can be composed of an arc surface and a flat surface, and is not specifically limited; in addition, each ball The number of the first structures on the balloon body may be one or more. If there are multiple first structures, the plurality of first structures may be arranged uniformly or unevenly in sequence along the circumferential direction of the tube body 11 .
在一实施方式中，每个所述球囊体在所述扩张状态时的整个外表面无凹陷，此时，外径大的部分能够贴靠血管壁，而外径小的部分能够与血管壁之间形成允许血液通过的通道。此时，外径大的部分作为所述第二构造，外径小的部分作为所述第一构造。可以理解，所述第一球囊体12上的外径小的部分与第二球囊体13上的外径小的部分在管体11的周向上错开。In one embodiment, the entire outer surface of each balloon body has no depression in the expanded state. At this time, the part with a large outer diameter can be close to the blood vessel wall, and the part with a small outer diameter can be in contact with the blood vessel wall. A channel is formed between them to allow blood to pass. At this time, the portion with a large outer diameter serves as the second structure, and the portion with a small outer diameter serves as the first structure. It can be understood that the portion of the first balloon body 12 with a small outer diameter and the portion of the second balloon body 13 with a small outer diameter are staggered in the circumferential direction of the tube body 11 .
在另一实施方式中，每个所述球囊体在所述扩张状态时的一部分外表面向内凹陷以形成凹槽14，可参见图1。此时，所述凹槽14作为所述第一构造，相对于凹槽14凸起的表面作为所述第二构造。且所述第一球囊体12上的凹槽14与第二球囊体13上的凹槽14在管体11的周向上错开。In another embodiment, a portion of the outer surface of each balloon body in the expanded state is recessed inwardly to form a groove 14, as shown in FIG. 1 . At this time, the groove 14 serves as the first structure, and the surface convex relative to the groove 14 serves as the second structure. Moreover, the groove 14 on the first balloon body 12 and the groove 14 on the second balloon body 13 are staggered in the circumferential direction of the tube body 11 .
本发明实施例中，每个所述球囊体在所述扩张状态时的外表面具有两个或更多的凹槽14，每个所述球囊体上的所有所述凹槽14沿所述管体11的周向均匀地设置。In the embodiment of the present invention, the outer surface of each balloon body in the expanded state has two or more grooves 14, and all the grooves 14 on each balloon body are along the The tube body 11 is arranged evenly in the circumferential direction.
不管球囊体、第一构造及第二构造的数量为多少，为了实现整个血管表面的药物的粘附，所有所述球囊体上的所述第二构造沿所述管体11的周向依次均匀或不均匀地设置。如此设置时，可以使所有第二构造沿着病变血管的整个周向都有设置，以实现对整个血管表面释放药物的效果。不同球囊体上的第二构造虽然沿管体的周向错开，但是错开可以是第二构造部分重叠或完全不重叠。Regardless of the number of balloons, first structures, and second structures, in order to achieve drug adhesion on the entire blood vessel surface, the second structures on all balloons are arranged along the circumferential direction of the tube body 11 Set evenly or unevenly in turn. When arranged in this way, all the second structures can be arranged along the entire circumference of the diseased blood vessel to achieve the effect of releasing drugs on the entire blood vessel surface. Although the second structures on different balloon bodies are staggered along the circumferential direction of the tube body, the stagger can be that the second structures partially overlap or do not overlap at all.
接下去结合图3至图10，对球囊体扩张后的横截面形状作进一步的说明。参阅图3至图10，任意一个所述球囊体扩张后的横截面形状可以为8字形101、优弧形102、半圆形103、椭圆形104、花瓣形105、长腰圆形106以及其他形状，所述其他形状例如为图7所示的矩形和半圆形相结合的第一组合107，或者为图8所示的三角形、矩形和半圆形相结合的第二组合108。这些球囊扩张后的形状，在球囊膨胀并部分贴壁时会有足够的血流通过球囊与血管之间的空间。那么，当球囊体扩张后的横截面形状为8字形101、优弧形102或花瓣形105时，可在球囊体的表面形成凹槽14以及凸起；当球囊体扩张后的横截面形状为半圆形103、椭圆形104、长腰圆形106、第一组合107和第二组合108时，可在球囊体的表面形成外径较大的部分以及外径较小的部分。Next, with reference to Figures 3 to 10, the cross-sectional shape of the balloon after expansion will be further described. Referring to Figures 3 to 10, the cross-sectional shape of any of the balloons after expansion can be a figure-eight shape 101, a superior arc shape 102, a semicircle 103, an oval 104, a petal shape 105, a long-waisted circle 106, and Other shapes, such as the first combination 107 of a rectangle and a semicircle shown in FIG. 7 , or the second combination 108 of a triangle, a rectangle, and a semicircle shown in FIG. 8 . The expanded shape of these balloons allows sufficient blood flow to pass through the space between the balloon and the blood vessel when the balloon is inflated and partially attached to the wall. Then, when the expanded cross-sectional shape of the balloon body is a figure-eight shape 101, a superior arc shape 102 or a petal shape 105, grooves 14 and protrusions can be formed on the surface of the balloon body; when the expanded cross-sectional shape of the balloon body When the cross-sectional shapes are semicircle 103, ellipse 104, long-waisted circle 106, first combination 107 and second combination 108, a part with a larger outer diameter and a part with a smaller outer diameter can be formed on the surface of the balloon body .
然而，本发明球囊体扩张后的形状不限于以上所列举的几种情况，例如图11所示，任意一个所述球囊体扩张后的横截面形状还可以是外圆109包绕内圆110的情况，外圆109作为第二构造，内圆110作为第一构造。如本领域技术人员可以理解，球囊体扩张后可以是各种形状，具体不作限定。在实践中，只要两个球囊体最突出的部分可以贴壁，同时两个球囊体非突出的部分不接触血管壁即可。However, the expanded shape of the balloon body of the present invention is not limited to the situations listed above. For example, as shown in Figure 11, the cross-sectional shape of any balloon body after expansion can also be such that the outer circle 109 surrounds the inner circle. In the case of 110, the outer circle 109 serves as the second structure and the inner circle 110 serves as the first structure. As those skilled in the art can understand, the balloon body can be in various shapes after expansion and is not specifically limited. In practice, it is sufficient as long as the most protruding parts of the two balloons can adhere to the wall and the non-protruding parts of the two balloons do not contact the blood vessel wall.
参阅图12及结合图1，在一具体实施例中，所述第一球囊体12和第二球囊体13均为8字形球囊，大小相同或不相同。两个球囊体在管体11的周向上交错设置，使得两个球囊体上的凹槽14错开，但是所述第一球囊体12和第二球囊体13可以垂直交错或非垂直交错，交错的角度优选为45°～90°。如此设置后，通过先后扩张两个球囊体，可将药物释放在整个病变血管上，使整个病变血管的表面都会粘附药物，克服了单个球囊体因为存在与血管壁不接触的部分导致未接触到球囊的血管表面无粘附药物的缺陷。而且该结构简单，手术操作简单方便，治疗效果好。Referring to Fig. 12 and in conjunction with Fig. 1, in a specific embodiment, the first balloon body 12 and the second balloon body 13 are both 8-shaped balloons with the same or different sizes. The two balloon bodies are staggered in the circumferential direction of the tube body 11 so that the grooves 14 on the two balloon bodies are staggered, but the first balloon body 12 and the second balloon body 13 can be vertically staggered or non-vertical. Staggered, the staggered angle is preferably 45° to 90°. After this setting, by expanding two balloons one after another, the drug can be released on the entire diseased blood vessel, so that the drug will adhere to the surface of the entire diseased blood vessel, overcoming the problem of a single balloon body due to the presence of parts that are not in contact with the blood vessel wall. There are no defects in drug adhesion on the vessel surface that is not in contact with the balloon. Moreover, the structure is simple, the surgical operation is simple and convenient, and the treatment effect is good.
所述垂直交错指的是第一球囊体12的横截面对称线L2与第二球囊体13的横截面对称线L1相互垂直，横截面对称线是经过凹槽14的对称线；所述非垂直交错指的是两个球囊体的横截面对称线不垂直，如第一球囊体12的横截面对称线L2与第二球囊体13的横截面对称线L1之间的角度优选为45°～90°。每个球囊体可具有关于管体11的纵向轴线对称设置的两个凹槽14，且在垂直于所述管体11的纵向轴线的同一个投影平面上，第一球囊体12上的凹槽14的投影和第二球囊体13上的凹槽14的投影在管体11的同一圆周上均匀或不均匀地分布。但是，需说明的是，根据血管尺寸和病变状态，可以采用不同的球囊体组合，可以是相同结构的两个球囊体交错并依次排布，也可以是不同结构的球囊体交错并依次排布，同时两个球囊体之间可以采用不同的角度交错排布，不限于前述所示意的45°～90°，还可以是小于45°。多个球囊体的结构相同可以是形状相同，但大小不同，或者大小和形状均相同；球囊体的结构不相同可以是形状不相同和/或大小不相同；并且大小或形状不同的球囊体可以采用各种角度交错依次排布。The perpendicular staggering means that the cross-sectional symmetry line L2 of the first balloon body 12 and the cross-sectional symmetry line L1 of the second balloon body 13 are perpendicular to each other, and the cross-sectional symmetry line is the symmetry line passing through the groove 14; Non-vertical staggering means that the cross-sectional symmetry lines of the two balloons are not perpendicular. For example, the angle between the cross-sectional symmetry line L2 of the first balloon body 12 and the cross-sectional symmetry line L1 of the second balloon body 13 is preferably It is 45°～90°. Each balloon body may have two grooves 14 symmetrically arranged with respect to the longitudinal axis of the tube body 11 , and on the same projection plane perpendicular to the longitudinal axis of the tube body 11 , the grooves 14 on the first balloon body 12 The projection of the groove 14 and the projection of the groove 14 on the second balloon body 13 are evenly or unevenly distributed on the same circumference of the tube body 11 . However, it should be noted that different combinations of balloons can be used depending on the size of the blood vessel and the condition of the disease. It can be that two balloons of the same structure are staggered and arranged in sequence, or balloons of different structures can be staggered and arranged. Arranged sequentially, at the same time, the two balloon bodies can be arranged staggered at different angles, which is not limited to the 45° to 90° shown above, and can also be less than 45°. The structures of multiple balloon bodies may be the same but have the same shape but different sizes, or both sizes and shapes may be the same; the balloon bodies having different structures may be different shapes and/or different sizes; and balloons with different sizes or shapes may have the same structure. The capsules can be arranged staggered and sequentially at various angles.
所述球囊导管10还可包括药物涂层，所述药物涂层设置在所述第二构造上，如设置在球囊体的凸起或外圆上，但是第一构造上不设置药物涂层。The balloon catheter 10 may further include a drug coating, which is disposed on the second structure, such as on the protrusion or outer circle of the balloon body, but is not disposed on the first structure. layer.
如以上所述，每个球囊体都设有各自的通液腔，使得所有球囊体都是相互独立地扩张或收缩，或者每个球囊体共用一个通液腔，使得所有球囊体同步扩张或收缩。接下去对管体11的结构做进一步的说明。As mentioned above, each balloon body is provided with its own liquid-passing cavity, so that all balloon bodies can expand or contract independently of each other, or each balloon body shares a liquid-passing cavity, so that all balloon bodies synchronized expansion or contraction. Next, the structure of the tube body 11 will be further described.
如图13至图16所示，在一实施例中，两个球囊体与两个通液腔一一对应地设置，但是两个通液腔的相对位置没有限定。图13为两个通液腔上下对称设置的具体示例，如图13所示，第一通液腔111和的第二通液腔112关于管体11的纵向轴线(中心轴线)上下对称设置。图14为两个通液腔左右对称设置的具体示例，如图14所示，第一通液腔111和的第二通液腔112还可以关于管体11的纵向轴线(中心轴线)左右对称设置。图15和图16为两个通液腔非对称设置的具体示例，如图15和图16所示，第一通液腔111和的第二通液腔112还可以关于管体11的纵向轴线(中心轴线)以其他方式排列。无论何种排列方式，所有通液腔只要在管体11的内部互不连通，互不干涉即可。为了不增加管体11的外径，优选，所有通液腔仅在同一圆周方向上排布，可减小管体11的壁厚。应理解，当球囊体的数量超过2个时，也是基本采用以上的方式来设置通液腔。As shown in FIGS. 13 to 16 , in one embodiment, two balloon bodies are arranged in one-to-one correspondence with two liquid-passing chambers, but the relative positions of the two liquid-passing chambers are not limited. Figure 13 is a specific example of two liquid-passing chambers arranged symmetrically up and down. As shown in Figure 13, the first liquid-passing chamber 111 and the second liquid-passing chamber 112 are arranged symmetrically up and down with respect to the longitudinal axis (central axis) of the tube body 11. Figure 14 is a specific example of two liquid-passing chambers being arranged symmetrically left and right. As shown in Figure 14, the first liquid-passing chamber 111 and the second liquid-passing chamber 112 can also be symmetrical about the longitudinal axis (central axis) of the tube body 11. set up. Figures 15 and 16 are specific examples of an asymmetric arrangement of two liquid-passing chambers. As shown in Figures 15 and 16, the first liquid-passing chamber 111 and the second liquid-passing chamber 112 can also be arranged about the longitudinal axis of the tube body 11 (central axis) arranged in other ways. Regardless of the arrangement, all liquid-passing cavities only need to be non-communicative and non-interfering with each other inside the tube body 11 . In order not to increase the outer diameter of the tube body 11, it is preferable that all the liquid-passing chambers are arranged only in the same circumferential direction, so as to reduce the wall thickness of the tube body 11. It should be understood that when the number of balloon bodies exceeds 2, the above method is basically used to set the liquid-passing chamber.
参阅图2，并结合图13至图16，当所述通液腔的数量为多个时，所述管体11可以是单层的多腔管，中间的一个腔体用于通导丝，并在管壁中设置相互独立的多个通液腔。在其他实施方式中，所述管体11可以是多层管，在相邻两层管材之间设置有至少一个所述通液腔。如两个球囊体对应两层管，在相邻两层管材之间设置互不连通的两个通液腔，分别与两个球囊体的内腔连通。更多的球囊体，则对应更多层的管材或者在两层管材之间设置更多的通液腔。在一具体实施例中，球囊体为两个，所述管体11可包括内管和外管，所述外管套设在内管的外周，并在内管和外管之间设置第一通液腔111和第二通液腔112。Referring to Figure 2, combined with Figures 13 to 16, when the number of the liquid-passing chambers is multiple, the tube body 11 can be a single-layer multi-lumen tube, and the middle chamber is used for the guide wire. And multiple independent liquid-passing cavities are provided in the pipe wall. In other embodiments, the tube body 11 may be a multi-layer tube, and at least one of the liquid-passing chambers is provided between two adjacent layers of tubes. For example, two balloon bodies correspond to two layers of tubes, and two liquid-passing cavities that are not connected to each other are provided between the adjacent two layers of tubes, respectively communicating with the inner cavities of the two balloon bodies. More balloons correspond to more layers of pipes or more liquid-passing cavities between two layers of pipes. In a specific embodiment, there are two balloon bodies. The tube body 11 may include an inner tube and an outer tube. The outer tube is sleeved on the outer periphery of the inner tube, and a third balloon is disposed between the inner tube and the outer tube. A liquid-passing chamber 111 and a second liquid-passing chamber 112 .
本实施例提供的球囊导管10可以是同轴式球囊导管，也可以是快速交换式球囊导管10。本领域技术人员可以根据现有技术对同轴式或快速交换式的技术进行理解，此处不再展开说明。The balloon catheter 10 provided in this embodiment may be a coaxial balloon catheter or a quick-exchange balloon catheter 10. Those skilled in the art can understand the coaxial type or fast switching type technology based on the existing technology, and will not be described here.
所述球囊体可以通过模具制作成型，也可以是，球囊体由多个球囊拼接而成，且每个球囊体可以套设在管体11的外周，也可采用非套设的方式将球囊体贴合在管体11的一侧。球囊体的材料没有要求，选用常规的球囊材料即可。The balloon body can be made by a mold, or it can be made up of multiple balloons, and each balloon body can be sleeved on the outer periphery of the tube body 11, or it can be non-sleeved. In this way, the balloon body is attached to one side of the tube body 11. There is no requirement for the material of the balloon body, just use conventional balloon materials.
综上，在本发明提供的球囊导管中，包括：管体和多个球囊体，所述多个球囊体沿所述管体的轴向依次设置在所述管体的远端；每个所述球囊体具有收缩状态和扩张状态，并能够在所述收缩状态和所述扩张状态之间切换；每个所述球囊体的一部分外表面在所述扩张状态时形成为允许血流通过的第一构造，另一部分外表面在所述扩张状态时形成为能够与目标腔壁贴靠的第二构造，且相邻两个所述球囊体上的所述第一构造在所述管体的周向上错开。可知，本发明通过在球囊体上设置第一构造，使球囊体的横截面不再是一个圆柱形，保证球囊体扩张时不完全阻断血流，同时通过多个球囊体的相互配合，不仅实现了使整个病变血管的表面充分粘附有药物，还实现了不完全阻断血流。那么，本发明可以使药物球囊的使用，不用再受时间的制约，使得药物可以更加充分地作用于血管壁，可以显著提升药物球囊的临床使用效果，有效地提升狭窄病变的治疗效果。In summary, the balloon catheter provided by the present invention includes: a tube body and a plurality of balloon bodies, the plurality of balloon bodies are sequentially arranged at the distal end of the tube body along the axial direction of the tube body; Each balloon body has a contracted state and an expanded state, and can be switched between the contracted state and the expanded state; a portion of the outer surface of each balloon body is formed to allow The first structure through which blood flow passes, the other part of the outer surface is formed into a second structure capable of abutting against the target cavity wall in the expanded state, and the first structures on two adjacent balloon bodies are in The circumferential direction of the tube body is staggered. It can be seen that the present invention disposes the first structure on the balloon body so that the cross-section of the balloon body is no longer a cylindrical shape, ensuring that the blood flow is not completely blocked when the balloon body is expanded, and at the same time, the blood flow through multiple balloon bodies is Cooperating with each other, not only the drug is fully adhered to the surface of the entire diseased blood vessel, but also the blood flow is not completely blocked. Then, the present invention can make the use of the drug balloon no longer subject to time constraints, so that the drug can more fully act on the blood vessel wall, which can significantly improve the clinical use effect of the drug balloon and effectively improve the therapeutic effect of stenotic lesions.
虽然本发明披露如上，但并不局限于此。本领域的技术人员可以对本发明进行各种改动和变型而不脱离本发明的精神和范围。这样，倘若本发明的这些修改和变型属于本发明及其等同技术的范围之内，则本发明也意图包含这些改动和变型在内。Although the present invention is disclosed above, it is not limited thereto. Various changes and modifications can be made to the present invention by those skilled in the art without departing from the spirit and scope of the invention. Thus, if these modifications and variations of the present invention fall within the scope of the present invention and equivalent technologies, the present invention is also intended to include these modifications and variations.
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202210541131.5ACN117100978A (en) | 2022-05-17 | 2022-05-17 | balloon catheter |
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202210541131.5ACN117100978A (en) | 2022-05-17 | 2022-05-17 | balloon catheter |
| Publication Number | Publication Date |
|---|---|
| CN117100978Atrue CN117100978A (en) | 2023-11-24 |
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202210541131.5APendingCN117100978A (en) | 2022-05-17 | 2022-05-17 | balloon catheter |
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| CN (1) | CN117100978A (en) |
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| CN217886753U (en)* | 2022-05-17 | 2022-11-25 | 微创神通医疗科技（上海）有限公司 | Balloon catheter |
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| CN112439122A (en)* | 2019-09-05 | 2021-03-05 | 尤东侠 | Balloon dilatation catheter |
| US20210308431A1 (en)* | 2020-04-03 | 2021-10-07 | Covidien Lp | Balloon catheter |
| CN111298274A (en)* | 2020-05-14 | 2020-06-19 | 上海脉全医疗器械有限公司 | Medicine balloon and using method thereof |
| CN112107774A (en)* | 2020-10-23 | 2020-12-22 | 恒壹（北京）医疗科技有限公司 | Self-perfusion medicine plugging balloon |
| CN112316282A (en)* | 2020-11-25 | 2021-02-05 | 北京管桥医疗科技有限公司 | Drug-coated balloon dilatation catheter for intracranial blood vessels |
| CN217886753U (en)* | 2022-05-17 | 2022-11-25 | 微创神通医疗科技（上海）有限公司 | Balloon catheter |
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