技术领域technical field
本发明涉及一种医疗用具，具体为一种球囊扩张导管。The invention relates to a medical appliance, in particular to a balloon dilation catheter.
背景技术Background technique
介入医疗器械是近年来新兴的医疗器械技术，其在减少对病人的创伤，提高疾病治疗效果方面起到非常重要的作用。例如，应用在人体各种管腔内的介入式球囊扩张导管可以用于动静脉血管狭窄或血管内支架（用于支撑血管管腔的可植入管状结构）内扩张治疗，治疗裸支架及药物支架无法治疗的疾病，如外周动脉血管阻塞或狭窄疾病治疗、动静脉瘘狭窄扩张治疗、支架内再狭窄治疗等等。而且，该介入式球囊扩张导管还可以作为输送器来输送各种支架，如血管支架、胆道支架、食道支架、肠道支架、胰管支架、尿道支架或气管支架等等。Interventional medical devices are emerging medical device technologies in recent years, which play a very important role in reducing trauma to patients and improving disease treatment effects. For example, interventional balloon dilatation catheters used in various lumens of the human body can be used for the treatment of arteriovenous stenosis or intravascular stent (implantable tubular structure used to support the lumen of blood vessels), treatment of bare stents and Diseases that cannot be treated with drug stents, such as the treatment of peripheral arterial vascular obstruction or stenosis, the treatment of arteriovenous fistula stenosis and dilatation, the treatment of in-stent restenosis, etc. Moreover, the interventional balloon dilatation catheter can also be used as a delivery device to deliver various stents, such as vascular stents, biliary stents, esophageal stents, intestinal stents, pancreatic duct stents, urethral stents, or tracheal stents.
其中，经皮血管腔内成形术（PTA或PTCA）是采用经皮穿刺技术将球囊扩张导管插入到血管狭窄处，在医学影像设备的导引和监控下，将球囊进行扩张，使血管狭窄部位扩张，增加血管血流量。在临床使用中，球囊扩张压力是影响治疗效果的一个非常重要的因素。球囊扩张导管的额定爆破压（RBP）是产品最重要的一个性能指标，由于液体对压力传递的稳定性和准确性远高于气体，临床医生穿刺置管前必须确保球囊扩张导管加压通道内无空气残留，才能向球囊内充盈液体，加压扩张血管狭窄处。Among them, percutaneous transluminal angioplasty (PTA or PTCA) uses percutaneous puncture technology to insert a balloon dilation catheter into the stenosis of the blood vessel. Under the guidance and monitoring of medical imaging equipment, the balloon is expanded to make the blood vessel Stenosis dilates, increasing blood flow to the vessel. In clinical use, the inflation pressure of the balloon is a very important factor affecting the therapeutic effect. The rated burst pressure (RBP) of the balloon dilatation catheter is the most important performance index of the product. Since the stability and accuracy of the pressure transmission of the liquid is much higher than that of the gas, the clinician must ensure that the balloon dilation catheter is pressurized before puncturing the catheter. Only when there is no air remaining in the channel, can the balloon be filled with liquid to pressurize and dilate the stenosis of the blood vessel.
通过对现有技术的研究，申请人发现，市场上现有的血管内球囊扩张导管以及在研发中的产品基本上都只有两个腔道（导丝腔和加压腔），PTA或PTCA球囊扩张导管推送管直径一般为1.4~2.3毫米，推送管长度一般为400~1350毫米，仅通过加压腔一个细长腔道很难同时实现向球囊导管内充盈液体和排尽空气的要求。目前血管内球囊扩张导管厂家多在产品说明书上要求医生通过一系列繁琐操作，通过反复抽负压、充盈液体的方式，确保加压腔内无空气残留。该操作耗时较长，并且由于推送管多为不透明材质，医生无法通过观察推送管加压腔内是否有气泡残留来判断空气是否已经排尽，若空气未排尽会影响压力传递，增加手术失败的风险。因此，亟需一种排气速度快，并且能从原理/结构上确保排尽加压腔和球囊内空气的球囊扩张导管。Through the research on the existing technology, the applicant found that the existing intravascular balloon dilatation catheters on the market and the products under development basically only have two lumens (guide wire lumen and pressurization lumen), PTA or PTCA The diameter of the pusher tube of the balloon dilatation catheter is generally 1.4-2.3 mm, and the length of the pusher tube is generally 400-1350 mm. It is difficult to simultaneously fill the balloon catheter with liquid and exhaust air only through a long and thin lumen of the pressurized cavity. Require. At present, most manufacturers of intravascular balloon dilatation catheters require doctors to go through a series of tedious operations in the product manuals, repeatedly pumping negative pressure and filling liquids to ensure that there is no air remaining in the pressurized cavity. This operation takes a long time, and because the push tube is mostly made of opaque material, the doctor cannot judge whether the air has been exhausted by observing whether there are air bubbles in the pressurized chamber of the push tube. If the air is not exhausted, the pressure transmission will be affected, which will increase the operation time risk of failure. Therefore, there is an urgent need for a balloon dilatation catheter that has a fast exhaust speed and can ensure that the pressurized chamber and the air in the balloon are completely exhausted from the principle/structure.
发明内容Contents of the invention
鉴于现有技术的上述技术问题，本发明的目的在于开发一种球囊扩张导管，该球囊扩张导管能够实现快速排除空气，并从原理/结构上确保加压通道内的空气已全部排尽。In view of the above-mentioned technical problems in the prior art, the object of the present invention is to develop a balloon dilation catheter, which can realize rapid air removal, and ensure that all the air in the pressurized channel has been exhausted from the principle/structure .
为了实现上述目的，本发明提供了一种球囊扩张导管，包括：导管接头（1）、应力分散管、推送管、球囊、显影标记、阻水膜、盖帽,其中：In order to achieve the above purpose, the present invention provides a balloon dilatation catheter, including: a catheter connector (1), a stress dispersion tube, a push tube, a balloon, a development mark, a water blocking film, and a cap, wherein:
所述推送管为中空结构，管体内部有3~4个单独的腔道，优选3个单独通道；该推送管的近端与所述导管接头相固定，该推送管的远端与所述球囊相固定且穿出所述球囊；The push tube is a hollow structure, and there are 3 to 4 separate lumens inside the tube body, preferably 3 separate channels; the proximal end of the push tube is fixed to the catheter joint, and the far end of the push tube is connected to the catheter joint. the balloon is secured and pierced out of the balloon;
其特征在于：It is characterized by:
所述推送管内部有三个单独腔道（进液腔、导丝腔和排气腔），进液腔截面积大于或等于排气腔截面积，分别与导管接头三个接口连通，导管接头三个接口间不能相互连通；并且所述推送管进液腔和排气腔在球囊包裹段实现互通。There are three separate chambers inside the push tube (inlet chamber, guide wire chamber and exhaust chamber), the cross-sectional area of the liquid inlet chamber is greater than or equal to the cross-sectional area of the exhaust chamber, and they are respectively connected with the three interfaces of the catheter joint, and the three joints of the catheter joint The two interfaces cannot communicate with each other; and the liquid inlet chamber and the exhaust chamber of the push tube communicate with each other at the balloon wrapping section.
优选的，排气腔截面积为进液腔截面积的10%~100%，其中排气腔截面积优选为进液腔截面积的40%。Preferably, the cross-sectional area of the exhaust chamber is 10% to 100% of the cross-sectional area of the liquid inlet chamber, wherein the cross-sectional area of the exhaust chamber is preferably 40% of the cross-sectional area of the liquid inlet chamber.
所述的球囊扩张导管，其特征在于，进液腔和排气腔在球囊包裹段的互通以在推送管上增加侧孔的方式实现，每个腔道对应的侧孔数量为1~5个，侧孔直径范围为0.5~6毫米，优选两个腔道对应的侧孔分布在球囊包裹段两端,不同腔道侧孔间的距离为6~220mm。The balloon dilatation catheter is characterized in that the communication between the liquid inlet chamber and the exhaust chamber in the balloon wrapping section is realized by adding side holes on the push tube, and the number of side holes corresponding to each lumen is 1~ There are 5 side holes with a diameter ranging from 0.5 to 6 mm. Preferably, the side holes corresponding to the two lumens are distributed at both ends of the balloon wrapping section, and the distance between the side holes of different lumens is 6 to 220 mm.
优选地，进液腔侧孔位置在球囊包裹段的远端，排气腔侧孔位置在球囊包裹段的近端。Preferably, the side hole of the liquid inlet chamber is located at the distal end of the balloon wrapping section, and the side hole of the exhaust chamber is located at the proximal end of the balloon wrapping section.
优选地，所述排气腔对应的导管接头出口处有一片通气阻水膜，该通气阻水膜可以通过超声焊接/热融焊接/机械压合等方式固定到接头上，阻水膜材质可为玻璃纤维、聚丙烯、丙烯酸共聚物、聚偏氟乙烯（PVDF）、聚四氟乙烯（PTPE）、聚对苯二甲酸乙二酯（PET）、聚酰胺（PA）中的一种或几种。Preferably, there is a piece of ventilation and water blocking film at the outlet of the conduit joint corresponding to the exhaust cavity, and the ventilation and water blocking film can be fixed to the joint by means of ultrasonic welding/thermal welding/mechanical pressing, etc., and the material of the water blocking film can be One or more of glass fiber, polypropylene, acrylic copolymer, polyvinylidene fluoride (PVDF), polytetrafluoroethylene (PTPE), polyethylene terephthalate (PET), polyamide (PA) kind.
优选地，所述排气腔对应的排气接口处有一与接口密封配合的盖帽，优选为螺牙互配式盖帽。Preferably, the exhaust port corresponding to the exhaust chamber has a cap sealingly fitted with the port, preferably a screw thread interfitting cap.
优选地，所述球囊扩张导管进一步包括应力分散管，该应力分散管设置在所述推送管和所述导管接头之间或包裹在所述推送管和所述导管接头的连接部位处。Preferably, the balloon dilation catheter further includes a stress dispersing tube, and the stress dispersing tube is arranged between the pushing tube and the catheter connector or wrapped at the connecting portion of the pushing tube and the catheter connector.
优选地，球囊、推送管材料为医用高分子材料，为Nylon（尼龙）和/或Pebax（嵌段聚醚酰胺）,或聚氨酯或硅胶，其中Nylon优选为Nylon 12。Preferably, the material of the balloon and the push tube is a medical polymer material, such as Nylon (nylon) and/or Pebax (block polyether amide), or polyurethane or silica gel, wherein Nylon is preferably Nylon 12.
优选地，球囊扩张导管进一步包括显影标记，所述显影标记嵌在或套在所述推送管上，且所述显影标记的位置与所述球囊的位置相对。Preferably, the balloon dilation catheter further includes a visualization mark, the visualization mark is embedded or sleeved on the push tube, and the position of the visualization mark is opposite to the position of the balloon.
优选地，显影标记材料为铂、铱、钽、钨等金属环的一种或几种，或包含钨、铋、钡一种或多种的化合物；且所述显影标记的位置与球囊位置相对。Preferably, the imaging marking material is one or more of metal rings such as platinum, iridium, tantalum, tungsten, or a compound containing one or more of tungsten, bismuth, and barium; and the position of the imaging marking is consistent with the position of the balloon relatively.
由以上发明的技术方案可见，本发明提供了一种球囊扩张导管，其中，在导管加压通道内增加一排气腔。在使用该球囊扩张导管时，医生只需正常操作（导管接头朝上，推送管远端自然下垂），往加压接口内注入液体，加压通道内的气体就可顺着进液腔连通在球囊远端的侧孔进入球囊，通过排气腔连通在球囊近端的侧孔进入排气腔，最终将空气经过通气阻水膜排出整个加压通道。由于排气腔截面积小于进液腔/球囊截面积，液体进入排气腔内流动的阻力明显大于充盈进液腔和球囊的阻力，兼之液体在本身重力作用下首先由低往高逐步充盈球囊，所以液体会先完全充盈进液腔和球囊后再进入排气腔。通气阻水膜可保证加压通道内空气快速排尽并且不会有液体流出。当临床需要高压扩张时，可在排尽空气后将排气接口处用密封盖帽拧紧，防止液体压力过大击穿阻水膜，导致液体流出。It can be seen from the technical solution of the above invention that the present invention provides a balloon dilatation catheter, wherein an exhaust chamber is added in the catheter pressurization channel. When using the balloon dilatation catheter, the doctor only needs to operate normally (catheter connector faces upward, and the distal end of the push tube hangs down naturally), inject liquid into the pressurized interface, and the gas in the pressurized channel can communicate along the liquid inlet chamber The side hole at the far end of the balloon enters the balloon, and is connected to the side hole at the proximal end of the balloon through the exhaust cavity to enter the exhaust cavity, and finally the air is discharged from the entire pressurized channel through the ventilation and water blocking membrane. Since the cross-sectional area of the exhaust chamber is smaller than the cross-sectional area of the liquid inlet chamber/balloon, the resistance of the liquid flowing into the exhaust chamber is significantly greater than the resistance of filling the liquid inlet chamber and the balloon, and the liquid first gradually increases from low to high under the action of its own gravity. The balloon is inflated so that fluid will completely fill the inlet chamber and balloon before entering the exhaust chamber. The ventilation and water blocking membrane can ensure that the air in the pressurized channel is exhausted quickly and no liquid will flow out. When high-pressure expansion is required clinically, the exhaust port can be tightened with a sealing cap after exhausting the air to prevent excessive liquid pressure from breaking down the water-blocking membrane and causing the liquid to flow out.
本发明提供的该球囊扩张导管不仅排气速度快，还能从原理/结构上确保排尽加压腔和球囊内空气，从而节省手术时间，同时可以提高手术成功率。The balloon dilatation catheter provided by the present invention not only has a fast exhaust speed, but also ensures that the pressurized chamber and the air in the balloon are completely exhausted from the principle/structure, thereby saving operation time and improving the success rate of the operation.
附图说明Description of drawings
图1为根据本发明的一个优选实施例提供的一种球囊扩张导管的局部剖视结构示意图；Fig. 1 is a partial cross-sectional structural schematic diagram of a balloon dilatation catheter provided according to a preferred embodiment of the present invention;
图2为根据本发明的一个优选实施例提供的一种球囊扩张导管的导管接头剖视结构示意图；Fig. 2 is a schematic cross-sectional structure diagram of a catheter joint of a balloon dilatation catheter provided according to a preferred embodiment of the present invention;
图3为根据本发明的一个优选实施例提供的一种球囊扩张导管的推送管截面示意图；Fig. 3 is a schematic cross-sectional view of a pushing tube of a balloon dilatation catheter according to a preferred embodiment of the present invention;
图4为根据本发明的一个优选实施例提供的一种球囊扩张导管的进液腔和排气腔侧孔示意图。Fig. 4 is a schematic diagram of side holes of a liquid inlet chamber and an exhaust chamber of a balloon dilatation catheter according to a preferred embodiment of the present invention.
具体实施方式Detailed ways
为了使本技术领域的人员更好地理解本申请中的技术方案，下面将结合本发明实施例中的附图，对本发明实施例中的技术方案进行清楚、完整的描述。显然，所描述的实施例仅仅是本申请一部分实施例，而不是全部的实施例。基于本申请所述的具体实施例，本领域普通技术人员在没有做出创造性劳动的前提下所获得的所有其它实施例，都应当落在本发明构思范围之内。In order to enable those skilled in the art to better understand the technical solutions in the present application, the technical solutions in the embodiments of the present invention will be clearly and completely described below in conjunction with the drawings in the embodiments of the present invention. Apparently, the described embodiments are only some of the embodiments of this application, not all of them. Based on the specific embodiments described in the present application, all other embodiments obtained by persons of ordinary skill in the art without making creative efforts should fall within the scope of the present invention.
以下参考附图来详细描述本发明的优选实施例。Preferred embodiments of the present invention are described in detail below with reference to the accompanying drawings.
图1为根据本发明的一个优选实施例提供的一种球囊扩张导管的局部剖视结构示意图。在该附图中，远端是指左端，近端是指右端。Fig. 1 is a partial cross-sectional structural schematic diagram of a balloon dilatation catheter provided according to a preferred embodiment of the present invention. In this drawing, the distal end means the left end, and the proximal end means the right end.
如图1所示，本发明的球囊扩张导管包括包括导管接头1、应力分散管2、推送管3、球囊4、显影标记5、阻水膜6、盖帽7，其中：导管接头有三个接口，11为进液接口，12为导丝接口，13为排气接口；推送管3为中空结构，管体内部有三个单独通道，腔道31为进液腔（对应11进液接口），腔道32为导丝腔（对应12导丝接口），腔道33为排气腔（对应13排气接口），各腔道/接口间不能相互连通；推送管3的近端与导管接头1相固定，远端与球囊4相固定且穿出球囊；进液腔31（对应球囊内41侧孔）和排气腔33（对应球囊内43侧孔）在球囊包裹段实现互通，导丝腔32对应推送管远端42开口，用于导丝贯穿导引。As shown in Figure 1, the balloon dilation catheter of the present invention includes a catheter connector 1, a stress dispersion tube 2, a push tube 3, a balloon 4, a development mark 5, a water blocking membrane 6, and a cap 7, wherein: the catheter connector has three 11 is the liquid inlet port, 12 is the guide wire port, and 13 is the exhaust port; the push tube 3 is a hollow structure, and there are three separate channels inside the tube body, and the cavity 31 is the liquid inlet chamber (corresponding to 11 liquid inlet port), The lumen 32 is the guide wire lumen (corresponding to the 12 guide wire interface), and the lumen 33 is the exhaust chamber (corresponding to the 13 exhaust interface), and the lumens/interfaces cannot communicate with each other; Phase fixed, the distal end is fixed with the balloon 4 and passes out of the balloon; the liquid inlet chamber 31 (corresponding to the side hole 41 in the balloon) and the exhaust chamber 33 (corresponding to the side hole 43 in the balloon) are realized in the balloon wrapping section The guide wire lumen 32 is opened corresponding to the distal end 42 of the push tube, and is used for guiding the guide wire through.
该结构球囊扩张导管临床使用时手持导管接头1充液排气，推送管3远端自然垂下。往进液接口11内注入液体时，加压通道内的气体可顺着进液腔31连通在球囊远端的侧孔41进入球囊4，通过球囊近端的侧孔43进入排气腔33，最终经过通气阻水膜7将空气排出整个加压通道。液体由进液接口11顺着进液腔31通过侧孔41（远端）流入球囊，由于排气腔33截面积远小于进液腔31和球囊的截面积，液体进入排气腔33内流动的阻力大于充盈进液腔31和球囊的阻力，兼之液体在本身重力作用下会首先由低往高逐步充盈球囊，所以液体会先完全充盈进液腔31和球囊4后再通过侧孔43（近端）流入排气腔33，最终液体在通气阻水膜6处止住，此时整个加压通道（进液接口11、进液腔31、球囊4、排气腔33、排气接头13）内气体被全部排出。当临床需要高压扩张时（球囊扩张压力大于通气止液膜的极限耐水压），可在排尽空气后将排气接口13处用盖帽7拧紧，防止液压过大击穿阻水膜，导致液体流出。When the balloon dilatation catheter with this structure is used clinically, the catheter connector 1 is filled with fluid and exhausted by hand, and the distal end of the push tube 3 hangs down naturally. When liquid is injected into the liquid inlet port 11, the gas in the pressurized channel can enter the balloon 4 along the liquid inlet chamber 31 and communicate with the side hole 41 at the far end of the balloon, and enter the exhaust gas through the side hole 43 at the proximal end of the balloon. The chamber 33 finally discharges the air from the entire pressurized passage through the ventilating and water-blocking membrane 7 . The liquid flows into the balloon from the liquid inlet port 11 along the liquid inlet chamber 31 through the side hole 41 (far end). Since the cross-sectional area of the exhaust chamber 33 is much smaller than the cross-sectional area of the liquid inlet chamber 31 and the balloon, the liquid enters the exhaust chamber 33 The resistance of the internal flow is greater than the resistance of filling the liquid inlet chamber 31 and the balloon, and the liquid will first gradually fill the balloon from low to high under the action of its own gravity, so the liquid will first completely fill the liquid inlet chamber 31 and the balloon 4 and then Flow into the exhaust chamber 33 through the side hole 43 (near end), and finally the liquid is stopped at the ventilating and water-blocking membrane 6. 33. The gas in the exhaust joint 13) is completely discharged. When high-pressure expansion is clinically required (the expansion pressure of the balloon is greater than the limit water pressure of the ventilated liquid-proof membrane), the exhaust port 13 can be tightened with the cap 7 after exhausting the air to prevent excessive hydraulic pressure from breaking down the water-resistant membrane, resulting in Liquid comes out.
在本申请实施例中，显影标记5有两个，它们分别设置在推送管3上，在与球囊4的两端相对的位置处。In the embodiment of the present application, there are two developing marks 5 , which are respectively arranged on the pushing tube 3 at positions opposite to the two ends of the balloon 4 .
在本发明中，推送管3、球囊4可采用医用高分子材料管制成，所述高分子材料包括为Nylon（尼龙）和/或Pebax（嵌段聚醚酰胺）,或聚氨酯或硅胶等材料中的一种或几种，采用医用高分子材料后，该介入式球囊扩张导管具有一定弹性，并且可以弯曲（手持导管接头，推送管远端在重力作用下自然下垂），同时还能够具有一定的强度，由此可以在人体血管内运动，不会对血管造成损伤。In the present invention, the push tube 3 and the balloon 4 can be made of medical polymer material tubes, and the polymer material includes Nylon (nylon) and/or Pebax (block polyether amide), or materials such as polyurethane or silica gel One or more of them, after using medical polymer materials, the interventional balloon dilatation catheter has a certain degree of elasticity and can be bent (the catheter connector is held in hand, and the distal end of the push tube naturally sags under the action of gravity), and it can also have With a certain strength, it can move in the blood vessels of the human body without causing damage to the blood vessels.
此外，在本发明中，所述球囊扩张导管是指本领域普通技术人员所熟知的各种球囊扩张导管，包括但不局限于PTA 球囊扩张导管、PTCA球囊扩张导管、球扩支架输送器等。In addition, in the present invention, the balloon dilation catheter refers to various balloon dilation catheters well known to those of ordinary skill in the art, including but not limited to PTA balloon dilation catheter, PTCA balloon dilation catheter, balloon expansion stent Conveyor etc.
以上所述仅是本申请的一些具体实施方式。应当指出，对于本技术领域的普通技术人员来说，在不脱离本申请发明原理和发明构思的前提下，还可以做出若干改进和变型，这些改进和变型也应视为落在本申请的保护范围和发明构思之内。The above descriptions are only some specific implementation manners of the present application. It should be pointed out that for those skilled in the art, without departing from the principles and concepts of the invention of the application, some improvements and modifications can also be made, and these improvements and modifications should also be regarded as falling within the scope of the application. Within the scope of protection and inventive concept.
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201910596586.5ACN110251809A (en) | 2019-07-04 | 2019-07-04 | A balloon dilatation catheter |
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201910596586.5ACN110251809A (en) | 2019-07-04 | 2019-07-04 | A balloon dilatation catheter |
| Publication Number | Publication Date |
|---|---|
| CN110251809Atrue CN110251809A (en) | 2019-09-20 |
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201910596586.5APendingCN110251809A (en) | 2019-07-04 | 2019-07-04 | A balloon dilatation catheter |
| Country | Link |
|---|---|
| CN (1) | CN110251809A (en) |
| Publication number | Priority date | Publication date | Assignee | Title |
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