技术领域Technical Field
本发明属于医疗器械技术领域，具体涉及一种可变径锥形球囊扩张导管。The invention belongs to the technical field of medical devices, and in particular relates to a variable-diameter conical balloon dilatation catheter.
背景技术Background Art
在血管成形术中，球囊导管用于机械地扩宽狭窄的血管并且将已在那里形成的斑块挤压向血管壁。由于人体的血管直径并不均匀，以下肢血管为例，越往下血管直径越小。对于一些长段病变，病变远端和近端直径差距较大。手术过程中，若选择的球囊直径过大，可能对病变远端血管过度撕裂造成损伤；若选择的球囊直径过小，病变近端不能完全贴壁，影响扩张效果。针对这类病变，近端直径大于远端直径的锥形球囊具有较佳的贴壁效果。During angioplasty, a balloon catheter is used to mechanically widen narrow blood vessels and squeeze plaques that have formed there against the vessel wall. Since the diameter of blood vessels in the human body is not uniform, for example, the diameter of the blood vessels in the lower limbs is smaller as they go down. For some long lesions, the diameter difference between the distal and proximal ends of the lesion is large. During the operation, if the selected balloon diameter is too large, it may cause damage to the distal blood vessels of the lesion due to excessive tearing; if the selected balloon diameter is too small, the proximal end of the lesion cannot be completely attached to the wall, affecting the expansion effect. For such lesions, a conical balloon with a proximal diameter larger than the distal diameter has a better wall-attaching effect.
然而，现有的锥形球囊的锥度多不可调节，不利于处理有难度的病变。并且，球囊远端和近端始终保持同时扩张或收缩，当处理远端病变较多、近端病变较少或近端没有病变的血管时，需要对病变较多的远端处进行局部扩张，这类的球囊近端不可避免地也会跟着扩张，容易对近端血管造成撕裂损伤。However, the taper of existing conical balloons is not adjustable, which is not conducive to treating difficult lesions. In addition, the distal and proximal ends of the balloon always expand or contract simultaneously. When treating blood vessels with more distal lesions and fewer proximal lesions or no proximal lesions, it is necessary to locally expand the distal end with more lesions. The proximal end of such balloons will inevitably expand as well, which can easily cause tearing damage to the proximal blood vessels.
发明内容Summary of the invention
本发明的目的是提供一种可变径锥形球囊扩张导管。The purpose of the invention is to provide a variable-diameter tapered balloon dilatation catheter.
为达到上述目的，本发明采用的技术方案是：To achieve the above object, the technical solution adopted by the present invention is:
一种可变径锥形球囊扩张导管，包括外球囊和设于所述外球囊内的内球囊，所述内球囊、所述外球囊可相对彼此独立地沿径向膨胀或收缩，A variable diameter tapered balloon dilatation catheter comprises an outer balloon and an inner balloon arranged inside the outer balloon, wherein the inner balloon and the outer balloon can expand or contract radially independently of each other.
所述外球囊具有依次连接的第一远端连接段、第一远端锥形主体、膨胀主体、第一近端锥形主体和第一近端连接段，所述第一远端锥形主体在膨胀状态下的直径由远及近逐渐扩大，所述膨胀主体在单独膨胀时的直径由远及近逐渐扩大，所述第一近端锥形主体在膨胀状态下的直径由远及近逐渐缩小；The outer balloon comprises a first distal connection section, a first distal conical body, an expansion body, a first proximal conical body and a first proximal connection section which are connected in sequence, the diameter of the first distal conical body gradually expands from far to near in an expanded state, the diameter of the expansion body gradually expands from far to near when expanded alone, and the diameter of the first proximal conical body gradually decreases from far to near in an expanded state;
所述内球囊具有依次连接的第二远端连接段、第二远端锥形主体、第二近端锥形主体和第二近端连接段，所述第二远端锥形主体在膨胀状态下的直径由远及近逐渐扩大，所述第二近端锥形主体在膨胀状态下的直径由远及近逐渐缩小，The inner balloon comprises a second distal connection section, a second distal conical body, a second proximal conical body and a second proximal connection section which are connected in sequence. The diameter of the second distal conical body gradually increases from far to near in an expanded state, and the diameter of the second proximal conical body gradually decreases from far to near in an expanded state.
当所述内球囊和所述外球囊分别独立地膨胀时，所述内球囊的最大直径能够大于所述膨胀主体的最小直径，且当所述内球囊向外膨胀时，所述内球囊能够驱使所述膨胀主体的远端沿径向向外扩张或使所述膨胀主体的远端保持扩张状态。When the inner balloon and the outer balloon are inflated independently, the maximum diameter of the inner balloon can be larger than the minimum diameter of the expansion body, and when the inner balloon expands outward, the inner balloon can drive the distal end of the expansion body to expand radially outward or keep the distal end of the expansion body in an expanded state.
优选地，所述外球囊至少具有三种膨胀状态，当所述外球囊处于第一膨胀状态时，所述膨胀主体的直径由远及近逐渐扩大；当所述外球囊处于第二膨胀状态时，所述膨胀主体的直径由远及近逐渐扩大且最小直径大于所述膨胀主体处于第一膨胀状态下的最小直径、最大直径不变；当所述外球囊处于第三膨胀状态下时，所述膨胀主体的不同区域的直径相等。Preferably, the outer balloon has at least three expansion states. When the outer balloon is in a first expansion state, the diameter of the expansion body gradually expands from far to near; when the outer balloon is in a second expansion state, the diameter of the expansion body gradually expands from far to near and the minimum diameter is greater than the minimum diameter of the expansion body in the first expansion state, and the maximum diameter remains unchanged; when the outer balloon is in a third expansion state, the diameters of different areas of the expansion body are equal.
一些实施方式中，当所述外球囊处于第一、第二膨胀状态时，所述膨胀主体呈圆锥台形。In some embodiments, when the outer balloon is in the first and second expansion states, the expansion body is in the shape of a truncated cone.
一些实施方式中，当所述外球囊处于第三膨胀状态时，所述膨胀主体呈圆柱形。In some embodiments, when the outer balloon is in the third expanded state, the expanded body is cylindrical.
优选地，所述第一远端锥形主体和所述膨胀主体的交接处形成第一分模线，所述第二远端锥形主体和所述第二近端锥形主体的交接处形成第二分模线，所述第一分模线和所述第二分模线重叠。Preferably, a first parting line is formed at the intersection of the first distal conical body and the expansion body, a second parting line is formed at the intersection of the second distal conical body and the second proximal conical body, and the first parting line and the second parting line overlap.
进一步优选地，所述第一分模线或所述第二分模线呈圆形。Further preferably, the first parting line or the second parting line is circular.
优选地，所述第一远端锥形主体和/或第一近端锥形主体与所述膨胀主体交接处的内侧壁上喷涂有显影剂。Preferably, a developer is sprayed on the inner side wall of the junction between the first distal conical body and/or the first proximal conical body and the expansion body.
优选地，所述第二远端锥形主体与所述第二近端锥形主体交接处的外侧壁上喷涂有显影剂Preferably, a developer is sprayed on the outer wall of the junction between the second distal conical body and the second proximal conical body.
优选地，所述可变径锥形球囊扩张导管还包括从内而外依次套设的内管、中间管和外管，所述内管插入所述内球囊且远端与所述第二远端连接段相连，所述第一远端连接段连接在所述第二远端连接段和/或所述内管远端，所述中间管远端插入所述内球囊与所述第二近端连接段相连，所述外管远端插入所述外球囊与所述第一近端连接段相连，所述内管和所述中间管之间形成有供膨胀介质流通的第一流通腔室，所述第一流通腔室与所述内球囊相连通，所述中间管和所述外管之间形成有供膨胀介质流通的第二流通腔室，所述第二流通腔室与所述外球囊相连通。Preferably, the variable diameter conical balloon dilatation catheter also includes an inner tube, an intermediate tube and an outer tube which are sequentially arranged from the inside to the outside, the inner tube is inserted into the inner balloon and the distal end is connected to the second distal connecting section, the first distal connecting section is connected to the second distal connecting section and/or the distal end of the inner tube, the distal end of the intermediate tube is inserted into the inner balloon and connected to the second proximal connecting section, the distal end of the outer tube is inserted into the outer balloon and connected to the first proximal connecting section, a first flow chamber for the circulation of inflation medium is formed between the inner tube and the intermediate tube, the first flow chamber is communicated with the inner balloon, a second flow chamber for the circulation of inflation medium is formed between the intermediate tube and the outer tube, the second flow chamber is communicated with the outer balloon.
优选地，所述可变径锥形球囊扩张导管还包括操作手柄，所述操作手柄具有分别与所述第一流通腔室、第二流通腔室相连通的第一充盈腔、第二充盈腔及与内管相连通且可用于通入导丝的导丝腔。Preferably, the variable diameter tapered balloon dilatation catheter also includes an operating handle, which has a first filling chamber and a second filling chamber respectively connected to the first circulation chamber and the second circulation chamber, and a guidewire chamber connected to the inner tube and used for inserting a guidewire.
优选地，所述操作手柄具有分别与所述内管、中间管、外管相连通的第一注胶通道、第二注胶通道和第三注胶通道，用于将与其对应的管件的近端封堵。Preferably, the operating handle has a first glue injection channel, a second glue injection channel and a third glue injection channel respectively connected to the inner tube, the middle tube and the outer tube, and is used to seal the proximal end of the corresponding pipe fitting.
本发明还提供一种使用如上所述的可变径锥形球囊扩张导管对血管进行扩张的方法，包括将球囊组件引入目标血管，向外球囊内通入膨胀介质使所述外球囊膨胀并与血管壁贴合，根据需求向内球囊内通入膨胀介质使所述内球囊膨胀，驱使所述外球囊的膨胀主体远端直径向外扩大以将其外侧的斑块挤压向血管壁，选择性地通出所述外球囊内的部分膨胀介质。The present invention also provides a method for dilating a blood vessel using the variable diameter conical balloon dilation catheter as described above, comprising introducing a balloon assembly into a target blood vessel, introducing an expansion medium into an outer balloon to expand the outer balloon and conform it to the blood vessel wall, introducing an expansion medium into an inner balloon as needed to expand the inner balloon, driving the distal end diameter of the expansion body of the outer balloon to expand outward to squeeze the plaque on its outside toward the blood vessel wall, and selectively passing a portion of the expansion medium in the outer balloon.
本发明还提供一种如上所述的可变径锥形球囊扩张导管的制备方法，包括将卷绕后的内球囊插入外球囊内，然后充气使所述内球囊和所述外球囊鼓起，将内管插入所述内球囊，并将第一远端连接段、第二远端连接段与所述内管远端三者焊接一起，The present invention also provides a method for preparing the variable diameter tapered balloon dilatation catheter as described above, comprising inserting a wound inner balloon into an outer balloon, then inflating the inner balloon and the outer balloon to swell, inserting an inner tube into the inner balloon, and welding a first distal end connecting section, a second distal end connecting section and the distal end of the inner tube together,
将中间管远端插入所述内球囊并与所述第二近端连接段焊接一起，Insert the distal end of the intermediate tube into the inner balloon and weld it together with the second proximal connecting section.
将外管远端插入所述内球囊和所述外球囊之间并将所述外管与所述第一近端连接段焊接一起。The distal end of the outer tube is inserted between the inner balloon and the outer balloon, and the outer tube is welded to the first proximal connecting section.
优选地，将所述内管、中间管、外管插入操作手柄上，并将所述内管、中间管、外管的近端封堵。Preferably, the inner tube, the middle tube and the outer tube are inserted into the operating handle, and the proximal ends of the inner tube, the middle tube and the outer tube are blocked.
由于上述技术方案运用，本发明与现有技术相比具有下列优点：Due to the application of the above technical solution, the present invention has the following advantages compared with the prior art:
本发明在锥形外球囊内设置内球囊，通过内球囊膨胀驱使外球囊膨胀主体的远端沿径向向外继续扩张或保持扩张状态，从而实现外球囊的锥度可调，具有更佳的治疗效果。The present invention arranges an inner balloon inside a conical outer balloon, and the inner balloon expands to drive the distal end of the outer balloon expansion body to continue to expand radially outward or maintain an expanded state, thereby achieving adjustable taper of the outer balloon and having a better treatment effect.
附图说明BRIEF DESCRIPTION OF THE DRAWINGS
为了更清楚地说明本申请实施例技术方案，下面将对实施例描述中所需要使用的附图作简单地介绍，显而易见地，下面描述中的附图仅仅是本申请的一些实施例，对于本领域普通技术人员来讲，在不付出创造性劳动的前提下，还可以根据这些附图获得其他的附图。In order to more clearly illustrate the technical solutions of the embodiments of the present application, the drawings required for use in the description of the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present application. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative work.
图1为实施例1中的可变径锥形球囊扩张导管的结构示意图；FIG1 is a schematic structural diagram of a variable diameter tapered balloon dilatation catheter in Example 1;
图2为实施例1中的可变径锥形球囊扩张导管的剖视图；FIG2 is a cross-sectional view of the variable diameter tapered balloon dilatation catheter in Example 1;
图3为图2中A部分的放大示意图；FIG3 is an enlarged schematic diagram of part A in FIG2 ;
图4为图2中B部分的放大示意图；FIG4 is an enlarged schematic diagram of part B in FIG2 ;
图5为实施例1的内球囊和外球囊的结构示意图，其中外球囊处于剖视状态；FIG5 is a schematic diagram of the structure of the inner balloon and the outer balloon of Example 1, wherein the outer balloon is in a cross-sectional state;
图6为实施例1的内球囊和外球囊的透视图，其中外球囊处于第一膨胀状态；FIG6 is a perspective view of the inner balloon and the outer balloon of Example 1, wherein the outer balloon is in a first expanded state;
图7为实施例1的内球囊和外球囊的透视图，其中外球囊处于第二膨胀状态；FIG7 is a perspective view of the inner balloon and the outer balloon of Example 1, wherein the outer balloon is in a second expanded state;
图8为实施例1的内球囊和外球囊的透视图，其中外球囊处于第三膨胀状态；FIG8 is a perspective view of the inner balloon and the outer balloon of Example 1, wherein the outer balloon is in a third expanded state;
其中：1、外球囊；11、第一远端连接段；12、第一远端锥形主体；13、膨胀主体；14、第一近端锥形主体；15、第一近端连接段；16、第一分模线；17、显影区；Wherein: 1, outer balloon; 11, first distal connecting section; 12, first distal conical body; 13, expansion body; 14, first proximal conical body; 15, first proximal connecting section; 16, first parting line; 17, developing area;
2、内球囊；21、第二远端连接段；22、第二远端锥形主体；23、第二近端锥形主体；24、第二近端连接段；25、第二分模线；2. inner balloon; 21. second distal connecting section; 22. second distal conical body; 23. second proximal conical body; 24. second proximal connecting section; 25. second parting line;
3、内管；4、中间管；5、外管；3. Inner tube; 4. Middle tube; 5. Outer tube;
6、操作手柄；61、第一充盈腔；62、第二充盈腔；63、导丝腔；6. Operating handle; 61. First filling chamber; 62. Second filling chamber; 63. Guide wire chamber;
7、导丝。7. Guide wire.
具体实施方式DETAILED DESCRIPTION
在下文中，仅简单地描述了某些示例性实施例。正如本领域技术人员可认识到的那样，在不脱离本发明实施例的精神或范围的情况下，可通过各种不同方式修改所描述的实施例。因此，附图和描述被认为本质上是示例性的而非限制性的。In the following, only some exemplary embodiments are briefly described. As those skilled in the art will appreciate, the described embodiments may be modified in various ways without departing from the spirit or scope of the embodiments of the present invention. Therefore, the drawings and descriptions are considered to be exemplary and non-restrictive in nature.
在本发明实施例的描述中，需要理解的是，术语“远”、“近”等指示的方位或位置关系是以锥形球囊扩张导管在使用时的方位进行定义的，其中靠近操作者的一侧为近端，远离操作者的一侧为远端。仅是为了便于描述本发明实施例和简化描述，而不是指示或暗示所指的装置或元件必须具有特定的方位、以特定的方位构造和操作，因此不能理解为对本发明实施例的限制。In the description of the embodiments of the present invention, it should be understood that the terms "distal", "proximal", etc., indicating the position or positional relationship, are defined by the position of the tapered balloon dilatation catheter when in use, wherein the side close to the operator is the proximal end, and the side away from the operator is the distal end. This is only for the convenience of describing the embodiments of the present invention and simplifying the description, and does not indicate or imply that the device or element referred to must have a specific position, be constructed and operated in a specific position, and therefore cannot be understood as limiting the embodiments of the present invention.
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更多个该特征。在本发明实施例的描述中，“多个”的含义是两个或两个以上，除非另有明确具体的限定。In addition, the terms "first" and "second" are used for descriptive purposes only and should not be understood as indicating or implying relative importance or implicitly indicating the number of the indicated technical features. Thus, a feature defined as "first" or "second" may explicitly or implicitly include one or more of the features. In the description of the embodiments of the present invention, the meaning of "plurality" is two or more, unless otherwise clearly and specifically defined.
在本发明实施例中，除非另有明确的规定和限定，第一特征在第二特征之“上”或之“下”可以包括第一和第二特征直接接触，也可以包括第一和第二特征不是直接接触而是通过它们之间的另外的特征接触。而且，第一特征在第二特征“之上”、“上方”和“上面”包括第一特征在第二特征正上方和斜上方，或仅仅表示第一特征水平高度高于第二特征。第一特征在第二特征“之下”、“下方”和“下面”包括第一特征在第二特征正下方和斜下方，或仅仅表示第一特征水平高度小于第二特征。In the embodiments of the present invention, unless otherwise clearly specified and limited, a first feature being "above" or "below" a second feature may include the first and second features being in direct contact, or may include the first and second features being in contact not directly but through another feature between them. Moreover, a first feature being "above", "above" and "above" a second feature includes the first feature being directly above and obliquely above the second feature, or simply indicates that the first feature is higher in level than the second feature. A first feature being "below", "below" and "below" a second feature includes the first feature being directly below and obliquely below the second feature, or simply indicates that the first feature is lower in level than the second feature.
下文的公开提供了许多不同的实施方式或例子用来实现本发明实施例的不同结构。为了简化本发明实施例的公开，下文中对特定例子的部件和设置进行描述。当然，它们仅仅为示例，并且目的不在于限制本发明实施例。此外，本发明实施例可以在不同例子中重复参考数字和/或参考字母，这种重复是为了简化和清楚的目的，其本身不指示所讨论各种实施方式和/或设置之间的关系。The disclosure below provides many different embodiments or examples to implement different structures of the embodiments of the present invention. In order to simplify the disclosure of the embodiments of the present invention, the parts and settings of specific examples are described below. Of course, they are only examples, and the purpose is not to limit the embodiments of the present invention. In addition, the embodiments of the present invention can repeat reference numbers and/or reference letters in different examples, and this repetition is for the purpose of simplification and clarity, which itself does not indicate the relationship between the various embodiments and/or settings discussed.
下面结合附图对本发明的实施例进行详细说明。The embodiments of the present invention are described in detail below with reference to the accompanying drawings.
实施例1Example 1
一种可变径锥形球囊扩张导管，如图1和2所示，包括球囊组件、管组件和操作手柄6。A variable diameter tapered balloon dilatation catheter, as shown in FIGS. 1 and 2 , comprises a balloon assembly, a tube assembly and an operating handle 6 .
球囊组件包括可相对彼此独立地沿径向膨胀或收缩的外球囊1和内球囊2。如图3、6至8所示，外球囊1为锥形球囊，具有依次连接的第一远端连接段11、第一远端锥形主体12、膨胀主体13、第一近端锥形主体14和第一近端连接段15。其中，膨胀主体13在单独膨胀时的直径由远及近逐渐扩大，具体呈圆锥台形，该结构对于远端小、近端大的血管具有更好的贴壁效果。第一远端锥形主体12在膨胀状态下的直径由远及近逐渐扩大，第一近端锥形主体14在膨胀状态下的直径由远及近逐渐缩小，第一远端锥形主体12、第二近端锥形主体23也呈圆锥台形。The balloon assembly includes an outer balloon 1 and an inner balloon 2 that can expand or contract radially independently of each other. As shown in Figures 3, 6 to 8, the outer balloon 1 is a conical balloon, having a first distal connecting section 11, a first distal conical body 12, an expansion body 13, a first proximal conical body 14 and a first proximal connecting section 15 connected in sequence. Among them, the diameter of the expansion body 13 gradually expands from far to near when it is expanded alone, and is specifically in the shape of a truncated cone. This structure has a better wall-adhering effect for blood vessels with a small distal end and a large proximal end. The diameter of the first distal conical body 12 in the expanded state gradually expands from far to near, and the diameter of the first proximal conical body 14 in the expanded state gradually shrinks from far to near. The first distal conical body 12 and the second proximal conical body 23 are also in the shape of a truncated cone.
由于体内血管及病变的复杂性，当血管远端具有较多的斑块等病变，近端病变较少或没有病变时，需要对血管远端病变进行单独额外挤压，而现有的锥形球囊锥度不可调，一旦加压，膨胀主体13的远端、近端同时向外膨胀，除了对需要额外施压的血管远端造成挤压外，不可避免地也会对良性的血管近端造成过度挤压，易导致血管近端的撕裂损伤。发明人创造性地在锥形外球囊1内设置内球囊2，利用内球囊2向外膨胀驱使膨胀主体13的远端向外扩张，从而实现膨胀主体13的远端单独扩大，即可实现外球囊1的锥度可调。以下对内球囊2作详细论述。Due to the complexity of blood vessels and lesions in the body, when the distal end of the blood vessel has more lesions such as plaques and fewer or no lesions at the proximal end, it is necessary to perform additional squeezing on the distal lesions of the blood vessel separately. However, the taper of the existing conical balloon is not adjustable. Once pressurized, the distal and proximal ends of the expansion body 13 expand outward at the same time. In addition to squeezing the distal end of the blood vessel that requires additional pressure, it will inevitably cause excessive squeezing on the benign proximal end of the blood vessel, which can easily lead to tearing damage at the proximal end of the blood vessel. The inventor creatively arranges an inner balloon 2 inside the conical outer balloon 1, and uses the outward expansion of the inner balloon 2 to drive the distal end of the expansion body 13 to expand outward, thereby achieving a separate expansion of the distal end of the expansion body 13, and the taper of the outer balloon 1 can be adjusted. The inner balloon 2 is discussed in detail below.
内球囊2设于外球囊1内，具有依次连接的第二远端连接段21、第二远端锥形主体22、第二近端锥形主体23和第二近端连接段24。其中，第二远端锥形主体22在膨胀状态下的直径由远及近逐渐扩大，第二近端锥形主体23在膨胀状态下的直径由远及近逐渐缩小，第二远端锥形主体22和第二近端锥形主体23优选呈圆锥台形。当内球囊2和外球囊1分别独立地膨胀时，内球囊2的最大直径(即第二近端锥形主体23与第二远端锥形主体22交接处的直径)能够大于膨胀主体13的最小直径(即膨胀主体13的远端直径)，从而对膨胀主体13的远端进行扩张。The inner balloon 2 is arranged in the outer balloon 1, and has a second distal connection section 21, a second distal conical body 22, a second proximal conical body 23 and a second proximal connection section 24 connected in sequence. The diameter of the second distal conical body 22 in the expanded state gradually expands from far to near, and the diameter of the second proximal conical body 23 in the expanded state gradually decreases from far to near. The second distal conical body 22 and the second proximal conical body 23 are preferably in the shape of a truncated cone. When the inner balloon 2 and the outer balloon 1 are expanded independently, the maximum diameter of the inner balloon 2 (i.e., the diameter at the junction of the second proximal conical body 23 and the second distal conical body 22) can be greater than the minimum diameter of the expanded body 13 (i.e., the distal diameter of the expanded body 13), thereby expanding the distal end of the expanded body 13.
为了更好地驱使膨胀主体13的远端向外扩张，第二远端锥形主体22和第二近端锥形主体23的交接处形成的第二分模线25与第一远端锥形主体12和膨胀主体13的交接处形成的第一分模线16重叠，参见图5。作为优选，第一分模线16或第二分模线25呈圆形。In order to better drive the distal end of the expansion body 13 to expand outward, the second parting line 25 formed at the intersection of the second distal conical body 22 and the second proximal conical body 23 overlaps the first parting line 16 formed at the intersection of the first distal conical body 12 and the expansion body 13, see Figure 5. Preferably, the first parting line 16 or the second parting line 25 is circular.
外球囊1至少具有三种膨胀状态，当外球囊1处于第一膨胀状态时，膨胀主体13的直径由远及近逐渐扩大，膨胀主体13呈圆锥台形，如图6所示；当外球囊1处于第二膨胀状态时，膨胀主体13的直径由远及近逐渐扩大且远端直径大于膨胀主体13处于第一膨胀状态下的远端直径、近端直径不变，即膨胀主体13处于第二膨胀状态下的锥度小于膨胀主体13处于第一状态下的锥度，膨胀主体13呈圆锥台形，如图7所示；当外球囊1处于第三膨胀状态下时，膨胀主体13不同区域的直径相等，膨胀主体13呈圆柱形，如图8所示。The outer balloon 1 has at least three expansion states. When the outer balloon 1 is in the first expansion state, the diameter of the expansion body 13 gradually expands from far to near, and the expansion body 13 is in the shape of a truncated cone, as shown in Figure 6; when the outer balloon 1 is in the second expansion state, the diameter of the expansion body 13 gradually expands from far to near, and the distal diameter is larger than the distal diameter of the expansion body 13 in the first expansion state, and the proximal diameter remains unchanged, that is, the taper of the expansion body 13 in the second expansion state is smaller than the taper of the expansion body 13 in the first state, and the expansion body 13 is in the shape of a truncated cone, as shown in Figure 7; when the outer balloon 1 is in the third expansion state, the diameters of different areas of the expansion body 13 are equal, and the expansion body 13 is cylindrical, as shown in Figure 8.
为了方便调整外球囊1锥度，第一远端锥形主体12和膨胀主体13交接处的内侧壁上或第二远端锥形主体22和第二近端锥形主体23交接处的外侧壁上设有显影区17，第一近端锥形主体14和膨胀主体13交接处的外侧壁上设有显影区17。作为优选，显影区17具有绕周向分布的多组，显影区17由显影剂喷涂形成，显影剂的成分可参照现有技术，例如可以是含有硫酸钡和钨粉的聚合物基涂料，其与胶水混合，稀释后通过喷涂管头端喷涂孔喷涂在相应位置，再通过紫外光固化形成。In order to facilitate the adjustment of the taper of the outer balloon 1, a developing area 17 is provided on the inner side wall at the junction of the first distal conical body 12 and the expansion body 13 or on the outer side wall at the junction of the second distal conical body 22 and the second proximal conical body 23, and a developing area 17 is provided on the outer side wall at the junction of the first proximal conical body 14 and the expansion body 13. Preferably, the developing area 17 has a plurality of groups distributed around the circumference, and the developing area 17 is formed by spraying a developer. The composition of the developer can refer to the prior art, for example, it can be a polymer-based coating containing barium sulfate and tungsten powder, which is mixed with glue, diluted, sprayed on the corresponding position through the spray hole at the head end of the spray tube, and then cured by ultraviolet light.
管组件包括从内而外依次套设的内管3、中间管4和外管5，内管3插入内球囊2且远端与第二远端连接段21相连，第一远端连接段11连接在第二远端连接段21外侧壁上，中间管4远端插入内球囊2与第二近端连接段24相连，外管5远端插入外球囊1与第一近端连接段15相连。内管3和中间管4之间形成有供膨胀介质流通的第一流通腔室，第一流通腔室与内球囊2相连通。中间管4和外管5之间形成有供膨胀介质流通的第二流通腔室，第二流通腔室与外球囊1相连通。The tube assembly includes an inner tube 3, an intermediate tube 4 and an outer tube 5 which are sequentially sleeved from the inside to the outside. The inner tube 3 is inserted into the inner balloon 2 and the distal end is connected to the second distal connection section 21. The first distal connection section 11 is connected to the outer side wall of the second distal connection section 21. The distal end of the intermediate tube 4 is inserted into the inner balloon 2 and connected to the second proximal connection section 24. The distal end of the outer tube 5 is inserted into the outer balloon 1 and connected to the first proximal connection section 15. A first flow chamber for the expansion medium to flow is formed between the inner tube 3 and the intermediate tube 4, and the first flow chamber is connected to the inner balloon 2. A second flow chamber for the expansion medium to flow is formed between the intermediate tube 4 and the outer tube 5, and the second flow chamber is connected to the outer balloon 1.
管组件近端连接在操作手柄6上，如图4所示，操作手柄6具有分别于第一流通腔室、第二流通腔室相连通的第一充盈腔61、第二充盈腔62及与内管3相连通且可用于通入导丝7的导丝腔63。操作手柄6具有分别与内管3、中间管4、外管5相连通的第一注胶通道、第二注胶通道和第三注胶通道，用于将胶水通入与其对应的管件近端将该近端封堵。The proximal end of the tube assembly is connected to the operating handle 6. As shown in FIG4 , the operating handle 6 has a first filling cavity 61 and a second filling cavity 62 respectively connected to the first circulation cavity and the second circulation cavity, and a guidewire cavity 63 connected to the inner tube 3 and used for passing the guidewire 7. The operating handle 6 has a first glue injection channel, a second glue injection channel and a third glue injection channel respectively connected to the inner tube 3, the middle tube 4 and the outer tube 5, which are used to pass glue into the proximal end of the corresponding pipe fitting to seal the proximal end.
工作原理：Working principle:
将球囊组件引入目标血管，向外球囊1内通入膨胀介质使外球囊1膨胀并与血管壁贴合，外球囊1处于第一膨胀状态，如图6所示；根据需求向内球囊2内通入膨胀介质使内球囊2膨胀，并驱使外球囊1的膨胀主体13远端向外扩张以将其外侧的斑块挤压向血管壁，外球囊1处于第二膨胀状态，如图7所示；使内球囊2保持扩张，根据需求适当通出外球囊1内的部分膨胀介质，使膨胀主体13近端缩小，从而减轻膨胀主体13近端对其外侧的血管壁的挤压，外球囊1处于第三膨胀状态，如图8所示。The balloon assembly is introduced into the target blood vessel, and an expansion medium is introduced into the outer balloon 1 to expand the outer balloon 1 and fit the blood vessel wall. The outer balloon 1 is in a first expansion state, as shown in FIG6 ; as needed, an expansion medium is introduced into the inner balloon 2 to expand the inner balloon 2, and the distal end of the expansion body 13 of the outer balloon 1 is driven to expand outward to squeeze the plaque outside it toward the blood vessel wall. The outer balloon 1 is in a second expansion state, as shown in FIG7 ; the inner balloon 2 is kept expanded, and as needed, part of the expansion medium in the outer balloon 1 is appropriately discharged to shrink the proximal end of the expansion body 13, thereby reducing the squeezing of the proximal end of the expansion body 13 on the blood vessel wall outside it. The outer balloon 1 is in a third expansion state, as shown in FIG8 .
上述实施例只为说明本发明的技术构思及特点，其目的在于让熟悉此项技术的人士能够了解本发明的内容并据以实施，并不能以此限制本发明的保护范围。凡根据本发明精神实质所作的等效变化或修饰，都应涵盖在本发明的保护范围之内。The above embodiments are only for illustrating the technical concept and features of the present invention, and their purpose is to enable people familiar with the technology to understand the content of the present invention and implement it accordingly, and they cannot be used to limit the protection scope of the present invention. Any equivalent changes or modifications made according to the spirit of the present invention should be included in the protection scope of the present invention.
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202410876046.3ACN118743816B (en) | 2024-07-02 | 2024-07-02 | A variable diameter tapered balloon dilatation catheter |
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202410876046.3ACN118743816B (en) | 2024-07-02 | 2024-07-02 | A variable diameter tapered balloon dilatation catheter |
| Publication Number | Publication Date |
|---|---|
| CN118743816Atrue CN118743816A (en) | 2024-10-08 |
| CN118743816B CN118743816B (en) | 2025-09-26 |
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202410876046.3AActiveCN118743816B (en) | 2024-07-02 | 2024-07-02 | A variable diameter tapered balloon dilatation catheter |
| Country | Link |
|---|---|
| CN (1) | CN118743816B (en) |
| Publication number | Priority date | Publication date | Assignee | Title |
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| US5645529A (en)* | 1993-03-11 | 1997-07-08 | C. R. Bard, Inc. | Devices for selectively directing inflation devices |
| US6258108B1 (en)* | 1996-09-13 | 2001-07-10 | Interventional Technologies, Inc. | Incisor-dilator with tapered balloon |
| US20090254064A1 (en)* | 2008-04-08 | 2009-10-08 | Cook Incorporated | Weeping balloon catheter |
| CN107261302A (en)* | 2017-05-04 | 2017-10-20 | 杭州启明医疗器械有限公司 | Foley's tube and its aerating device for expanding aorta petal |
| CN207627725U (en)* | 2017-05-04 | 2018-07-20 | 杭州启明医疗器械有限公司 | A kind of double-layered balloon catheter for expanding aorta petal |
| CN211094642U (en)* | 2019-09-05 | 2020-07-28 | 海杰亚（北京）医疗器械有限公司 | Double-layer balloon |
| CN113317916A (en)* | 2020-02-28 | 2021-08-31 | 上海微创医疗器械（集团）有限公司 | Balloon catheter, delivery system and stent system |
| CN113730769A (en)* | 2021-09-18 | 2021-12-03 | 上海御瓣医疗科技有限公司 | Double-balloon capable of being positioned and expanded accurately |
| CN216061635U (en)* | 2020-12-30 | 2022-03-18 | 上海微创心通医疗科技有限公司 | Dilatation balloon and balloon dilatation catheter |
| CN116212209A (en)* | 2023-04-12 | 2023-06-06 | 上海以心医疗器械有限公司 | A kind of interventional operation balloon and balloon catheter |
| CN219517514U (en)* | 2023-02-28 | 2023-08-15 | 普利瑞医疗科技（苏州）有限公司 | Filling pressure-adjustable taper perfusion bundling balloon catheter |
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5645529A (en)* | 1993-03-11 | 1997-07-08 | C. R. Bard, Inc. | Devices for selectively directing inflation devices |
| US6258108B1 (en)* | 1996-09-13 | 2001-07-10 | Interventional Technologies, Inc. | Incisor-dilator with tapered balloon |
| US20090254064A1 (en)* | 2008-04-08 | 2009-10-08 | Cook Incorporated | Weeping balloon catheter |
| CN107261302A (en)* | 2017-05-04 | 2017-10-20 | 杭州启明医疗器械有限公司 | Foley's tube and its aerating device for expanding aorta petal |
| CN207627725U (en)* | 2017-05-04 | 2018-07-20 | 杭州启明医疗器械有限公司 | A kind of double-layered balloon catheter for expanding aorta petal |
| CN211094642U (en)* | 2019-09-05 | 2020-07-28 | 海杰亚（北京）医疗器械有限公司 | Double-layer balloon |
| CN113317916A (en)* | 2020-02-28 | 2021-08-31 | 上海微创医疗器械（集团）有限公司 | Balloon catheter, delivery system and stent system |
| CN216061635U (en)* | 2020-12-30 | 2022-03-18 | 上海微创心通医疗科技有限公司 | Dilatation balloon and balloon dilatation catheter |
| CN113730769A (en)* | 2021-09-18 | 2021-12-03 | 上海御瓣医疗科技有限公司 | Double-balloon capable of being positioned and expanded accurately |
| CN219517514U (en)* | 2023-02-28 | 2023-08-15 | 普利瑞医疗科技（苏州）有限公司 | Filling pressure-adjustable taper perfusion bundling balloon catheter |
| CN116212209A (en)* | 2023-04-12 | 2023-06-06 | 上海以心医疗器械有限公司 | A kind of interventional operation balloon and balloon catheter |
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| CN118743816B (en) | 2025-09-26 |
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