WO2015074602A1

WO2015074602A1 - Medical balloon, manufacturing method therefor, and balloon expansion catheter

Info

Publication number: WO2015074602A1
Application number: PCT/CN2014/091893
Authority: WO
Inventors: 王婷; 杨海; 唐智荣
Original assignee: 上海微创医疗器械（集团）有限公司
Priority date: 2013-11-21
Filing date: 2014-11-21
Publication date: 2015-05-28
Also published as: CN104645487B; CN104645487A

Abstract

A medical balloon (1; 2; 3; 4; 5) and a manufacturing method therefor. The medical balloon (1; 2; 3; 4; 5) has a relatively small contour diameter after the pressure of the balloon is released, and has a good capability of passing through a diseased region. The medical balloon (1; 2; 3; 4; 5) comprises a balloon conical portion (121, 122) and a balloon straight segment (11). The balloon straight segment (11) is circumferentially provided with multiple raised longitudinal ribs (13; 21, 22, 23; 311, 312, 313; 411, 412; 511, 512, 513) arranged spaced apart from one another. The longitudinal ribs (13; 21, 22, 23; 311, 312, 313; 411, 412; 511, 512, 513) can be formed by coating a strip-shaped coating layer onto the balloon straight segment (11).

Description

医用球囊及其制造方法和球囊扩张导管Medical balloon, manufacturing method thereof and balloon dilatation catheter

技术领域Technical field

本发明涉及一种医用球囊及其制造方法和球囊扩张导管。The present invention relates to a medical balloon, a method of manufacturing the same, and a balloon dilatation catheter.

背景技术Background technique

据世界卫生组织统计，心脏病等慢性病已成为人类最主要的死亡原因，占年度死亡总人数超过60％，其中尤以冠心病患者居多。血管成型术(PCI)则是有效治疗各类血管疾病的方法，其通过经皮穿刺病人外周动脉***球囊导管至病变血管，扩张狭窄的病变部位，使病变血管疏通的一种微创技术。According to the World Health Organization, chronic diseases such as heart disease have become the leading cause of death in humans, accounting for more than 60% of the total annual deaths, especially among patients with coronary heart disease. Angioplasty (PCI) is a method for the effective treatment of various vascular diseases. It is a minimally invasive technique for percutaneously puncturing the peripheral artery of a patient into a balloon catheter to expand the stenotic lesion and clear the diseased blood vessel.

球囊扩张导管是由远端具有扩张能力的球囊和近端管段组成。当球囊扩张导管的球囊部分推送至病变处时，通过液体压力使球囊扩充，使得病变血管开通，血流恢复正常，手术结束，回抽液体球囊泄压，然后把导管从病人体血管中取出。The balloon dilatation catheter is composed of a balloon having a distal expansion capability and a proximal tube segment. When the balloon portion of the balloon dilatation catheter is pushed to the lesion, the balloon is expanded by the fluid pressure, the diseased blood vessel is opened, the blood flow returns to normal, the operation is finished, the fluid balloon is released, and the catheter is removed from the patient. Remove from the blood vessels.

随着PCI手术的广泛开展，医生治疗的病变越来越复杂，因此对导管的性能要求就越来越高。目前临床应用中，导管存在的最大问题就是通不过病变部位，约占质量投诉反馈的80％左右。为了提升导管的通过病变能力，多数公司主要的措施包括减小导管的通过外径(crossing profile)尺寸，和导管表面进行涂层处理，特别是导管的球囊部分。With the extensive development of PCI surgery, the lesions treated by doctors are becoming more and more complex, so the performance requirements for catheters are getting higher and higher. At present, the biggest problem in the clinical application is that the lesion does not pass through the lesion, accounting for about 80% of the quality complaint feedback. In order to improve the ability of the catheter to pass through the lesion, most companies' main measures include reducing the size of the catheter's crossing profile, and coating the catheter surface, particularly the balloon portion of the catheter.

另一方面，在球囊完成扩张后的回撤过程中，球囊泄压后的轮廓直径(profile)过大，容易导致血管壁损伤和植入后的支架移位，降低了手术的疗效。最后，尽管医疗器械的一次性使用显著降低了感染的风险，但也导致了患者治疗成本的增加，而如何提高医疗器械在同一患者治疗中的多次使用率将是有效的解决办法。为了实现球囊扩张后的顺利回撤及多次使用率，降低球囊泄压后的轮廓直径是最可行的方式。球囊扩张泄压后，球囊无法重新回折到术前的低轮廓直径状态，最多能回复为均匀的三翼、四翼和五翼的状态，决定其轮廓直径大小的是其能够恢复的翼数，回复的翼数越多，形成的轮廓直径就越小。On the other hand, during the withdrawal process after the balloon is expanded, the contour of the balloon after the pressure is released is too large, which easily leads to damage of the blood vessel wall and displacement of the stent after implantation, thereby reducing the curative effect of the operation. Finally, although the one-time use of medical devices significantly reduces the risk of infection, it also leads to an increase in the cost of treatment for patients, and how to increase the multiple use rate of medical devices in the same patient treatment will be an effective solution. In order to achieve a smooth withdrawal and multiple use rate after balloon dilation, it is the most feasible way to reduce the contour diameter after balloon release. After balloon dilation and pressure relief, the balloon can not be re-folded back to the low profile diameter before surgery, and can be restored to a uniform shape of three wings, four wings and five wings. State, the size of the contour is determined by the number of wings it can recover, the more the number of wings recovered, the smaller the diameter of the contour formed.

因此一方面需提高球囊通过病变部位的能力，另一方面应当使球囊在完成扩张后的回撤过程中，泄压后的轮廓直径尽可能地小。Therefore, on the one hand, it is necessary to improve the ability of the balloon to pass through the lesion site, and on the other hand, the contour diameter of the balloon after the pressure reduction is as small as possible during the withdrawal process after the expansion is completed.

发明内容Summary of the invention

有鉴于此，本发明的主要目的是提供一种医用球囊及其制造方法和球囊扩张导管，该球囊在泄压后具有较小的轮廓直径，本发明的另一目的是使球囊还同时具有较好的通过病变部位的能力。In view of the above, it is a primary object of the present invention to provide a medical balloon, a method of manufacturing the same, and a balloon dilatation catheter having a smaller profile diameter after pressure relief, and another object of the present invention is to make a balloon It also has a good ability to pass through the lesion.

为实现上述目的，根据本发明的一个方面，提供了一种医用球囊。To achieve the above object, according to one aspect of the present invention, a medical balloon is provided.

本发明的医用球囊包括球囊锥部和球囊平直段，在所述球囊平直段上，沿周向间隔设置有多条凸起的纵向筋。The medical balloon of the present invention comprises a balloon cone and a balloon straight section, and a plurality of convex longitudinal ribs are circumferentially spaced apart on the straight section of the balloon.

可选地，所述纵向筋是通过在所述球囊平直段上涂覆带状涂层而形成。Optionally, the longitudinal ribs are formed by applying a strip coating on the straight sections of the balloon.

可选地，所述涂层为聚氨酯类涂层、亲水润滑涂层、丙烯酸类涂层、或者有机硅高弹涂层。Optionally, the coating is a polyurethane-based coating, a hydrophilic lubricating coating, an acrylic coating, or a silicone high-elastic coating.

可选地，所述亲水润滑涂层为聚环氧乙烷、丙烯酸或丙烯酰胺类亲水聚合物、或者聚乙烯吡咯烷酮。Optionally, the hydrophilic lubricating coating is a polyethylene oxide, acrylic or acrylamide hydrophilic polymer, or polyvinylpyrrolidone.

可选地，所述纵向筋是一体成型在球囊平直段上的具有较大厚度的条状区域。Optionally, the longitudinal rib is a strip-shaped region having a large thickness integrally formed on a straight section of the balloon.

可选地，所述纵向筋在球囊平直段表面平行于球囊轴向延伸。Optionally, the longitudinal rib extends axially parallel to the balloon at a surface of the straight section of the balloon.

可选地，所述纵向筋的延伸方向与球囊轴向之间的夹角大于零，使所述纵向筋在球囊平直段表面顺时针或逆时针旋转延伸。Optionally, an angle between the extending direction of the longitudinal rib and the axial direction of the balloon is greater than zero, such that the longitudinal rib extends in a clockwise or counterclockwise rotation on the flat surface of the balloon.

可选地，所述夹角小于15°。Optionally, the included angle is less than 15°.

可选地，所述纵向筋的数目为3、4或5。Optionally, the number of longitudinal ribs is 3, 4 or 5.

可选地，所述纵向筋沿球囊周向等间距设置。Optionally, the longitudinal ribs are disposed equidistantly along the circumference of the balloon.

可选地，所述医用球囊的材料为聚氨酯弹性体、尼龙、嵌段聚醚酰胺树脂、聚烯烃、或者聚酯。Optionally, the material of the medical balloon is a polyurethane elastomer, a nylon, a block polyether amide tree. Fat, polyolefin, or polyester.

根据本发明的另一方面，提供了一种球囊扩张导管，该球囊扩张导管的远端具有本发明的医用球囊。According to another aspect of the invention, a balloon dilatation catheter is provided having a distal end of the balloon dilatation catheter having a medical balloon of the invention.

根据本发明的又一方面，提供了一种制造医用球囊的方法。According to yet another aspect of the invention, a method of making a medical balloon is provided.

本发明的这种制造医用球囊的方法包括：将球囊管材放入模具中，经过拉伸吹胀后成型，所述模具的腔的横剖面形状有多个向外部膨胀的区域，使成型的球囊上，沿周向间隔分布有多条凸起的纵向筋。The method for manufacturing a medical balloon of the present invention comprises: placing a balloon tube into a mold and forming it by stretch inflation, wherein a cross-sectional shape of the cavity of the mold has a plurality of regions that expand outwardly, so that the molding is performed. On the balloon, a plurality of raised longitudinal ribs are distributed along the circumferential direction.

可选地，所述模具的腔的横剖面形状为三角形、菱形或五边形。Optionally, the cross-sectional shape of the cavity of the mold is a triangle, a diamond or a pentagon.

根据本发明的又一方面，提供了另一种制造医用球囊的方法。According to yet another aspect of the invention, another method of making a medical balloon is provided.

本发明的这种制造医用球囊的方法包括：将球囊管材经拉伸吹胀后初步成型，然后将初步成型后的球囊置于模具中，再将球囊充压至预设压强，最后将模具升温至预设温度并持续预设时长；其中，所述模具的腔的横剖面形状有多个向外部膨胀的区域，使成型的球囊上，沿周向间隔分布有多条凸起的纵向筋。The method for manufacturing a medical balloon of the present invention comprises: initially forming a balloon tube after being stretched and inflated, and then placing the initially formed balloon in a mold, and then pressing the balloon to a preset pressure, Finally, the mold is heated to a preset temperature for a preset period of time; wherein the cross-sectional shape of the cavity of the mold has a plurality of regions that expand outwardly, so that a plurality of convexities are distributed along the circumferential direction on the formed balloon. Longitudinal ribs.

根据本发明的技术方案，球囊平直段上具有多条凸起的纵向筋，使球囊泄压后形成以纵向筋为顶部的翼状结构，此时的球囊具有较小的轮廓直径，易于回撤；采用亲水润滑涂层形成纵向筋既能使球囊在折叠压握状态下具有良好的通过性，又使其在扩张状态下能够精准扩张病变部位，还可使其泄压后具有较小的轮廓直径。According to the technical solution of the present invention, the plurality of convex longitudinal ribs are arranged on the straight section of the balloon, so that the balloon is released to form a wing-like structure with the longitudinal rib as the top, and the balloon has a smaller profile diameter at this time. Easy to withdraw; the use of a hydrophilic lubricating coating to form the longitudinal ribs not only enables the balloon to have good passability in the folded and grip state, but also allows it to accurately expand the lesion in the expanded state, and also allows it to be relieved Has a smaller profile diameter.

附图说明DRAWINGS

附图用于更好地理解本发明，不构成对本发明的不当限定。其中：The drawings are intended to provide a better understanding of the invention and are not intended to limit the invention. among them:

图1是根据本发明实施例的一种球囊在扩张状态的外形的示意图；1 is a schematic view showing the outer shape of a balloon in an expanded state according to an embodiment of the present invention;

图2是根据本发明实施例的具有三条纵向筋的球囊折叠压握的状态的示意图； 2 is a schematic view showing a state of a balloon folding press with three longitudinal ribs according to an embodiment of the present invention;

图3是根据本发明实施例的具有三条纵向筋的球囊扩张泄压后的状态的示意图；3 is a schematic view showing a state in which a balloon having three longitudinal ribs is expanded and decompressed according to an embodiment of the present invention;

图4是根据本发明实施例的另一种球囊的外形的示意图；4 is a schematic view showing the outer shape of another balloon according to an embodiment of the present invention;

图5是根据本发明实施例的球囊在扩张状态下的截面的示意图；Figure 5 is a schematic illustration of a cross section of a balloon in an expanded state, in accordance with an embodiment of the present invention;

图6A是根据本发明实施例的一种制造球囊的模具的主视图和剖面B-B示意图；6A is a front view and a cross-sectional view taken along line B-B of a mold for manufacturing a balloon according to an embodiment of the present invention;

图6B是6A中的剖面A-A的示意图；Figure 6B is a schematic view of section A-A in 6A;

图6C是图6A中的剖面B-B的放大示意图；Figure 6C is an enlarged schematic view of a section B-B of Figure 6A;

图7A、图7B、图7C是根据本发明实施例的另一种制造球囊的模具的示意图。7A, 7B, and 7C are schematic views of another mold for manufacturing a balloon according to an embodiment of the present invention.

具体实施方式detailed description

以下结合附图对本发明的示范性实施例做出说明，其中包括本发明实施例的各种细节以助于理解，应当将它们认为仅仅是示范性的。因此，本领域普通技术人员应当认识到，可以对这里描述的实施例做出各种改变和修改，而不会背离本发明的范围和精神。同样，为了清楚和简明，以下的描述中省略了对公知功能和结构的描述。The exemplary embodiments of the present invention are described with reference to the accompanying drawings, and are in the Therefore, it will be apparent to those skilled in the art that various modifications and changes may be made to the embodiments described herein without departing from the scope and spirit of the invention. Also, descriptions of well-known functions and constructions are omitted in the following description for clarity and conciseness.

图1是根据本发明实施例的一种球囊在扩张状态的外形的示意图。如图1所示，球囊1在扩张状态下，具有球囊平直段11和位于球囊平直段11两端的球囊锥部121、122。在球囊平直段11的圆周方向上分布有多条凸起的沿球囊轴向延伸的纵向筋13，在图示视图下可看到一条纵向筋，纵向筋可以是三至五条或者更多。1 is a schematic view of the outer shape of a balloon in an expanded state, in accordance with an embodiment of the present invention. As shown in Fig. 1, the balloon 1 has a balloon straight section 11 and

balloon cones

121, 122 at both ends of the balloon straight section 11 in an expanded state. In the circumferential direction of the straight section 11 of the balloon, a plurality of convex longitudinal ribs 13 extending along the axial direction of the balloon are distributed. In the illustrated view, a longitudinal rib can be seen, and the longitudinal rib can be three to five or more. many.

以采用三条纵向筋为例，其折叠压握的状态如图2所示。图2是根据本发明实施例的具有三条纵向筋的球囊折叠压握的状态的示意图。图2是横剖面的视图，球囊2在折叠处的端部有纵向筋21、22、23。这种球囊在扩张泄压后的状态如图3所示，图3是根据本发明实施例的具有三条纵向筋的球囊扩张泄压后的状态的横剖面示意图。由于凸起的纵向筋的存在，相邻纵向筋之间的球囊壁的强度低于纵向筋所在位置的强度，因此泄压时相邻纵向筋之间的球囊壁更容易向内弯曲，从而形成以纵向筋为顶部的翼状结构，从而使球囊泄压后具有较小的轮廓直径，例如图3中的球囊3的三条纵向筋311、312、313分别位于翼321、322、323的顶部。纵向筋的数目越多，在球囊扩张泄压后回复的翼数就越多。但纵向筋不宜过多，否则球囊反而难以回复。Taking three longitudinal ribs as an example, the state of the folding press is as shown in FIG. 2 . 2 is a schematic view of a state in which a balloon folding press with three longitudinal ribs is performed according to an embodiment of the present invention. Figure 2 is a cross-sectional view of the balloon 2 with

longitudinal ribs

21, 22, 23 at the ends of the fold. The state of the balloon after expansion and pressure relief is as shown in FIG. 3, and FIG. 3 is a ball having three longitudinal ribs according to an embodiment of the present invention. A schematic cross-sectional view of the state after the balloon is expanded and released. Due to the presence of the raised longitudinal ribs, the strength of the balloon wall between adjacent longitudinal ribs is lower than the strength of the longitudinal ribs, so that the balloon wall between adjacent longitudinal ribs is more likely to bend inward during pressure relief. Thereby forming a wing-like structure with the longitudinal ribs as the top, so that the balloon has a smaller profile diameter after being released from pressure, for example, the three

longitudinal ribs

311, 312, 313 of the balloon 3 in FIG. 3 are located at the

wings

321, 322, 323, respectively. the top of. The greater the number of longitudinal tendons, the more flaps are recovered after the balloon is expanded and released. However, the longitudinal tendons should not be too much, otherwise the balloon will be difficult to recover.

从图3可以看出如果球囊在扩张泄压后形成的各翼如能有所倾斜，则有助于减小此时球囊的轮廓直径。为此，一种优选的结构是使纵向筋与球囊轴向之间具有一定的夹角，该夹角是指纵向筋和球囊轴线在平行于球囊轴线的平面上的投影之间的夹角。该夹角可以在15°之内。参见图4，图4是根据本发明另一实施例的采用了倾斜纵向筋设计的球囊的外形的示意图，其中球囊4的表面有多条倾斜的纵向筋，在图示视图下可看到两条411、412。这种倾斜的纵向筋可以是三至五条或者更多，它们在球囊表面以顺时针或逆时针旋转延伸。It can be seen from Fig. 3 that if the wings formed after the expansion and pressure relief are tilted, it helps to reduce the contour diameter of the balloon at this time. To this end, a preferred configuration is such that there is a certain angle between the longitudinal rib and the axial direction of the balloon, which is between the projection of the longitudinal rib and the balloon axis in a plane parallel to the axis of the balloon. Angle. The angle can be within 15°. Referring to FIG. 4, FIG. 4 is a schematic view showing the outer shape of a balloon adopting a tilted longitudinal rib design according to another embodiment of the present invention, wherein the surface of the balloon 4 has a plurality of inclined longitudinal ribs, which can be seen in the illustrated view. To two 411, 412. Such inclined longitudinal ribs may be three to five or more, and they extend in a clockwise or counterclockwise rotation on the surface of the balloon.

形成纵向筋的一种优选方式是在球囊平直段上涂覆带状涂层，这种涂层可以选择聚氨酯类涂层、亲水润滑涂层、丙烯酸类涂层、或者有机硅高弹涂层等。其中优选的方式是采用亲水润滑涂层，例如聚环氧乙烷、丙烯酸或丙烯酰胺类亲水聚合物、或者聚乙烯吡咯烷酮等。当球囊被扩张后的涂层位置如图5所示，图5是根据本发明实施例的球囊在扩张状态下的横截面的示意图。在图5中，球囊5的涂层511、512、513各自形成纵向筋。涂层的存在使得球囊壁在纵向筋处与纵向筋之间的力学性质发生差异，这样在球囊5泄压后纵向筋之间的球囊壁更易于收缩，同样能够形成类似于图3中所示的翼，从而得到较小的球囊轮廓直径。可以直接在被扩张的球囊表面涂敷涂层，为了涂敷的准确性，可将被扩张的球囊置于一个镂空的模壳中，对镂空部位进行涂层即可。 A preferred way of forming the longitudinal ribs is to apply a strip coating on the straight section of the balloon. The coating may be selected from a polyurethane coating, a hydrophilic lubricating coating, an acrylic coating, or a silicone high elastic. Coating, etc. A preferred mode of this is to use a hydrophilic lubricating coating such as a polyethylene oxide, acrylic or acrylamide hydrophilic polymer, or polyvinylpyrrolidone or the like. When the balloon is expanded, the position of the coating is as shown in Fig. 5. Fig. 5 is a schematic view showing a cross section of the balloon in an expanded state according to an embodiment of the present invention. In Figure 5, the

coatings

511, 512, 513 of the balloon 5 each form a longitudinal rib. The presence of the coating causes the mechanical properties of the balloon wall to differ between the longitudinal ribs and the longitudinal ribs such that the balloon wall between the longitudinal ribs is more likely to shrink after the balloon 5 is released, and can also be formed similar to FIG. The wings shown in this result in a smaller balloon contour diameter. The coating can be applied directly to the surface of the expanded balloon. For the accuracy of application, the expanded balloon can be placed in a hollowed-out mold to coat the hollowed portion.

因为采用亲水润滑涂层，除了形成纵向筋从而降低球囊在扩张泄压后的外廓直径以外，由于亲水润滑涂层的润滑性能，还有助于提高通过病变部位的能力；并且从图5可以看出，球囊在扩张状态下，其表面仅在一部分涂有亲水润滑涂层，所以球囊在扩张时不容易打滑，能够精准扩张病变部位，因而总的来说采用亲水润滑涂层形成纵向筋既能使球囊在折叠压握状态下具有良好的通过性，又使其在扩张状态下能够精准扩张病变部位，还可使其泄压后具有较小的轮廓直径，所以具有一举三得的效果。Because of the hydrophilic lubricating coating, in addition to forming the longitudinal ribs to reduce the outer diameter of the balloon after expansion and pressure relief, due to the lubricating properties of the hydrophilic lubricating coating, it also helps to improve the ability to pass through the lesion; As can be seen in Fig. 5, in the expanded state, the balloon is coated with a hydrophilic lubricating coating on only a part of the surface, so the balloon is not easy to slip when it is expanded, and the lesion can be accurately expanded, so that hydrophilicity is generally used. The formation of the longitudinal ribs of the lubricating coating not only enables the balloon to have good passage in the folded and grip state, but also enables it to accurately expand the lesion in the expanded state, and also has a smaller contour diameter after being released from pressure. So it has the effect of three things.

在实现中，可选用规格为2530球囊，球囊材料为PEBAX7233，涂层材料可选用聚乙烯吡咯烷酮PVP。按照图1所示，在球囊1扩张状态下涂敷涂层材料，以在球囊平直段11的圆周方向上形成三条凸起的纵向筋13。涂敷涂层后的球囊回抽排空后得到如图3的状态，将三个翼向同一方向折叠得到如图2所示的折叠状态，在该折叠状态下，亲水润滑涂覆层位于折叠球囊的三个翼的顶部，该位置处为折叠球囊外廓直径最大处。由于三个翼均被折叠压握，因而在每个翼的顶部，所述涂层一部分位于翼的外侧(即折叠球囊的外层)，一部分位于翼的内侧。涂层后结果：球囊在14atm下，1:1造影液，充压10次，均回复均匀三翼。涂层材料还可选用聚氧化乙烯PEO，按图4进行涂层，这样球囊在扩张泄压后形成旋转均匀三翼。涂覆亲水润滑涂层后，构建了三点滑轮结构，有利于球囊的首次和二次推送以及病变的穿越。In the implementation, the available size is 2530 balloon, the balloon material is PEBAX7233, and the coating material can be selected from polyvinylpyrrolidone PVP. According to Fig. 1, the coating material is applied in the expanded state of the balloon 1 to form three convex longitudinal ribs 13 in the circumferential direction of the straight section 11 of the balloon. After the coated balloon is evacuated and evacuated, the state of FIG. 3 is obtained, and the three wings are folded in the same direction to obtain a folded state as shown in FIG. 2, in which the hydrophilic lubricating coating layer is formed. Located at the top of the three wings of the folded balloon, this position is the largest diameter of the folded balloon. Since the three wings are folded and crimped, at the top of each wing, the coating is located on the outside of the wing (ie, the outer layer of the folded balloon) and a portion on the inside of the wing. Results after coating: The balloon was at 14 atm, 1:1 contrast medium, and 10 times of pressure, all of which returned to the uniform three wings. The coating material may also be selected from polyethylene oxide PEO, which is coated as shown in Fig. 4, so that the balloon forms a rotating uniform three-wing after expansion and pressure relief. After applying the hydrophilic lubricating coating, a three-point pulley structure is constructed, which is beneficial to the first and second push of the balloon and the passage of the lesion.

纵向筋也可以是球囊材料在条状区域上增厚而形成，可采用如图6A至图7C的模具来实现。例如，可采用内径0.0230inch、外径0.0355inch的球囊管材，将其放入如图6A至图6C所示的模具中经过拉伸吹胀后成型。图6A是根据本发明实施例的一种制造球囊的模具的主视图和横剖面B-B示意图，图6B是6A中的纵剖面A-A的示意图，图6C是图6A中的横剖面B-B的放大示意图。其中模具60的腔61的横剖面形状有四个向外部膨胀的区域611、612、613、614，从而球囊材料在这四个区域增厚形成纵向筋。这四条纵向筋的厚度不同于球囊的其他部分，形成纵向平均分布在球囊平直段上的条纹。纵向筋处的厚度为1.5mil，球囊其他部分的厚度为1.2mil，球囊名义直径为3.5mm，其耐压为20atm。The longitudinal ribs may also be formed by thickening the balloon material over the strip-like regions, and may be implemented using a mold as shown in Figs. 6A to 7C. For example, a balloon tube having an inner diameter of 0.0230 inch and an outer diameter of 0.0355 inch may be used, and it is placed in a mold as shown in FIGS. 6A to 6C and stretched and inflated. 6A is a front view and a cross-sectional view BB of a mold for manufacturing a balloon according to an embodiment of the present invention, FIG. 6B is a schematic view of a longitudinal section AA in FIG. 6A, and FIG. 6C is an enlarged schematic view of a cross section BB in FIG. 6A. . The cross-sectional shape of the cavity 61 of the mold 60 has four

regions

611, 612, 613, 614 that expand outwardly, so that the balloon material is thickened in these four regions to form longitudinal ribs. These four The thickness of the longitudinal ribs is different from the other portions of the balloon, forming stripes that are evenly distributed longitudinally over the straight segments of the balloon. The thickness of the longitudinal tendons is 1.5 mils, the thickness of the other parts of the balloon is 1.2 mils, the nominal diameter of the balloons is 3.5 mm, and the withstand voltage is 20 atm.

图7A、图7B、图7C是根据本发明实施例的另一种制造球囊的模具的示意图，其中图7A、图7B和图7C分别是主视图、A-A纵剖面图及B-B横剖面图。先将外径为0.0385inch、内径为0.0265inch的PEBAX球囊管材经过拉伸吹胀后初步成型，初步成型后的球囊再置于图7A至图7C所示的可加热中空模具70的腔71中，其中模具70的腔71的横剖面形状为菱形，将球囊充压至6atm后，模具开始升温至100℃，5min后泄压取出，得到完全成型的球囊。由于模具70中的腔71的横剖面形状，即菱形具有四个顶角711、712、713、714，使得到的球囊具有四条厚度不同于其他部分、且在球囊周向上平均间隔分布在球囊平直段上的纵向条纹，此部分的厚度为1.6mil，球囊其他部分的厚度为1.3mil，球囊名义直径为4.0mm，其耐压为19atm。本领域普通技术人员可以很容易地想到，制造球囊的模具的横剖面形状也可以是三角形或者五边形，以形成三条或者五条厚度不同于球囊其他部分的纵向筋。此外，本领域普通技术人员也可以理解，只要将模具的内壁做成倾斜的，就能制造出如图4所示的具有倾斜的纵向筋的球囊。7A, 7B, and 7C are schematic views of another mold for manufacturing a balloon according to an embodiment of the present invention, wherein Figs. 7A, 7B, and 7C are a front view, an A-A longitudinal cross-sectional view, and a B-B cross-sectional view, respectively. The PEBAX balloon tube having an outer diameter of 0.0385 inch and an inner diameter of 0.0265 inch is firstly formed after being stretched and inflated, and the initially formed balloon is placed in the cavity of the heatable hollow mold 70 shown in FIGS. 7A to 7C. In the 71, the cross-sectional shape of the cavity 71 of the mold 70 is a rhombus shape. After the balloon is pressurized to 6 atm, the mold starts to heat up to 100 ° C, and after 5 minutes, the pressure is taken out to obtain a completely formed balloon. Due to the cross-sectional shape of the cavity 71 in the mold 70, that is, the diamond has four

apex angles

711, 712, 713, 714, the resulting balloon has four thicknesses different from the other portions and is evenly spaced in the circumferential direction of the balloon. The longitudinal stripe on the straight section of the balloon, the thickness of this part is 1.6 mil, the thickness of the other part of the balloon is 1.3 mil, the nominal diameter of the balloon is 4.0 mm, and the withstand voltage is 19 atm. One of ordinary skill in the art will readily recognize that the cross-sectional shape of the mold from which the balloon is made may also be triangular or pentagonal to form three or five longitudinal ribs having a thickness different from the rest of the balloon. Moreover, it will be understood by those skilled in the art that a balloon having inclined longitudinal ribs as shown in Fig. 4 can be manufactured by making the inner wall of the mold inclined.

球囊材料还可以选用聚氨酯弹性体、尼龙、嵌段聚醚酰胺树脂、聚烯烃、聚酯等。制成的球囊可应用于各种球囊扩张导管中，将其设置在导管远端即可。The balloon material may also be selected from polyurethane elastomer, nylon, block polyether amide resin, polyolefin, polyester, and the like. The prepared balloon can be applied to various balloon dilatation catheters and placed at the distal end of the catheter.

上述具体实施方式，并不构成对本发明保护范围的限制。本领域技术人员应该明白的是，取决于设计要求和其他因素，可以发生各种各样的修改、组合、子组合和替代。任何在本发明的精神和原则之内所作的修改、等同替换和改进等，均应包含在本发明保护范围之内。 The above specific embodiments do not constitute a limitation of the scope of the present invention. Those skilled in the art will appreciate that a wide variety of modifications, combinations, sub-combinations and substitutions can occur depending on design requirements and other factors. Any modifications, equivalent substitutions and improvements made within the spirit and scope of the invention are intended to be included within the scope of the invention.

Claims

一种医用球囊，包括球囊锥部和球囊平直段，其特征在于，在所述球囊平直段上，沿周向间隔设置有多条凸起的纵向筋。A medical balloon comprising a balloon cone and a balloon straight section, wherein a plurality of raised longitudinal ribs are circumferentially spaced apart on the straight section of the balloon.
根据权利要求1所述的医用球囊，其特征在于，所述纵向筋是通过在所述球囊平直段上涂覆带状涂层而形成。The medical balloon of claim 1 wherein said longitudinal ribs are formed by applying a strip coating to said straight sections of said balloon.
根据权利要求2所述的医用球囊，其特征在于，所述涂层为聚氨酯类涂层、亲水润滑涂层、丙烯酸类涂层、或者有机硅高弹涂层。The medical balloon according to claim 2, wherein the coating is a polyurethane-based coating, a hydrophilic lubricating coating, an acrylic coating, or a silicone high-elastic coating.
根据权利要求3所述的医用球囊，其特征在于，所述亲水润滑涂层为聚环氧乙烷、丙烯酸或丙烯酰胺类亲水聚合物、或者聚乙烯吡咯烷酮。The medical balloon according to claim 3, wherein the hydrophilic lubricating coating is a polyethylene oxide, acrylic or acrylamide hydrophilic polymer, or polyvinylpyrrolidone.
根据权利要求1所述的医用球囊，其特征在于，所述纵向筋是一体成型在球囊平直段上的具有较大厚度的条状区域。The medical balloon according to claim 1, wherein said longitudinal rib is a strip-shaped region having a large thickness integrally formed on a straight section of the balloon.
根据权利要求1至5中任一项所述的医用球囊，其特征在于，所述纵向筋在球囊平直段表面平行于球囊轴向延伸。The medical balloon according to any one of claims 1 to 5, wherein the longitudinal rib extends axially parallel to the balloon at a surface of the straight section of the balloon.
根据权利要求1至5中任一项所述的医用球囊，其特征在于，所述纵向筋的延伸方向与球囊轴向之间的夹角大于零，使所述纵向筋在球囊平直段表面顺时针或逆时针旋转延伸。The medical balloon according to any one of claims 1 to 5, wherein an angle between the extending direction of the longitudinal rib and the axial direction of the balloon is greater than zero, so that the longitudinal rib is flat in the balloon The straight section surface extends clockwise or counterclockwise.
根据权利要求7所述的医用球囊，其特征在于，所述夹角小于15°。The medical balloon of claim 7 wherein said included angle is less than 15°.
根据权利要求1至5中任一项所述的医用球囊，其特征在于，所述纵向筋的数目为3、4或5。The medical balloon according to any one of claims 1 to 5, wherein the number of the longitudinal ribs is 3, 4 or 5.
根据权利要求1至5中任一项所述的医用球囊，其特征在于，所述纵向筋沿球囊周向等间距设置。The medical balloon according to any one of claims 1 to 5, wherein the longitudinal ribs are disposed at equal intervals in the circumferential direction of the balloon.
根据权利要求1至5中任一项所述的医用球囊，其特征在于，所述医用球囊的材料为聚氨酯弹性体、尼龙、嵌段聚醚酰胺树脂、聚烯烃、或者聚酯。The medical balloon according to any one of claims 1 to 5, wherein the medical balloon is made of a polyurethane elastomer, nylon, a block polyetheramide resin, a polyolefin, or a polyester.
一种球囊扩张导管，其特征在于，远端具有权利要求1至11中任一项所述的医用球囊。A balloon dilatation catheter characterized in that the distal end has any of claims 1 to 11 A medical balloon as described.
一种制造医用球囊的方法，其特征在于，包括：A method of manufacturing a medical balloon, comprising:

将球囊管材放入模具中，经过拉伸吹胀后成型，所述模具的腔的横剖面形状有多个向外部膨胀的区域，使成型的球囊上，沿周向间隔分布有多条凸起的纵向筋。The balloon tube is placed in a mold and formed by stretching and inflating. The cross-sectional shape of the cavity of the mold has a plurality of regions that expand outwardly, so that a plurality of strips are circumferentially spaced on the formed balloon. Raised longitudinal ribs.
根据权利要求13所述的方法，其特征在于，所述模具的腔的横剖面形状为三角形、菱形或五边形。The method according to claim 13, wherein the cavity of the mold has a cross-sectional shape of a triangle, a diamond or a pentagon.
一种制造医用球囊的方法，其特征在于，包括：A method of manufacturing a medical balloon, comprising:

将球囊管材经拉伸吹胀后初步成型，然后将初步成型后的球囊置于模具中，再将球囊充压至预设压强，最后将模具升温至预设温度并持续预设时长；After the balloon tube is stretched and inflated, the balloon is initially formed, and then the initially formed balloon is placed in the mold, and then the balloon is pressurized to a preset pressure, and finally the mold is heated to a preset temperature for a preset period of time. ;

其中，所述模具的腔的横剖面形状有多个向外部膨胀的区域，使成型的球囊上，沿周向间隔分布有多条凸起的纵向筋。Wherein, the cross-sectional shape of the cavity of the mold has a plurality of regions that expand outwardly, so that a plurality of convex longitudinal ribs are distributed along the circumferential direction on the formed balloon.
根据权利要求15所述的方法，其特征在于，所述模具的腔的横剖面形状为三角形、菱形或五边形。 The method according to claim 15, wherein the cavity of the mold has a cross-sectional shape of a triangle, a diamond or a pentagon.