CN117959050A - Recoverable spiral sacculus support - Google Patents
Recoverable spiral sacculus support Download PDFInfo
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- CN117959050A CN117959050A CN202410382131.4A CN202410382131A CN117959050A CN 117959050 A CN117959050 A CN 117959050A CN 202410382131 A CN202410382131 A CN 202410382131A CN 117959050 A CN117959050 A CN 117959050A
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
- A61F2/88—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure the wire-like elements formed as helical or spiral coils
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/92—Stents in the form of a rolled-up sheet expanding after insertion into the vessel, e.g. with a spiral shape in cross-section
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
- A61F2/958—Inflatable balloons for placing stents or stent-grafts
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
- A61F2/962—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
- A61F2/966—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
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- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
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Abstract
一种可回收的螺旋球囊支架，包括：球囊，充盈后的球囊为螺旋状，球囊两端的层间距不大于中间段，以在球囊两端提供更高的支撑力；充盈导管，充盈导管包括充盈腔，充盈导管位于所述球囊的侧边，以使血流更加通畅；支撑丝，支撑丝一端为螺旋状，位于球囊内部，支撑丝尾端设置有平直段，平直段延伸至充盈导管内部，提高了充盈导管的抗打折能力；装载套管，使用前球囊以长条状放置于装载套管内；球囊在输送鞘管中为长条状，释放出鞘管后，在支撑丝弹性的作用下，球囊变为螺旋状，然后对球囊充盈以提高其支撑性能，螺旋状的结构提供了更高的柔顺性，放置达到预期时间后，对球囊泄压，然后通过充盈导管拉出体外。
A recyclable spiral balloon stent comprises: a balloon, which is spiral after being filled, and the interlayer distance between the two ends of the balloon is not greater than the middle section, so as to provide a higher support force at the two ends of the balloon; a filling catheter, which comprises a filling cavity, and the filling catheter is located on the side of the balloon, so as to make the blood flow smoother; a support wire, one end of the support wire is spiral and located inside the balloon, and the tail end of the support wire is provided with a straight section, and the straight section extends to the inside of the filling catheter, so as to improve the anti-bending ability of the filling catheter; a loading sleeve, before use, the balloon is placed in the loading sleeve in a long strip; the balloon is in a long strip in the delivery sheath, and after the sheath is released, the balloon becomes spiral under the action of the elasticity of the support wire, and then the balloon is filled to improve its support performance, and the spiral structure provides higher flexibility, and after the expected placement time, the balloon is depressurized and then pulled out of the body through the filling catheter.
Description
技术领域Technical Field
本发明专利涉及医疗器械领域，尤其涉及一种可回收的螺旋球囊支架。The invention patent relates to the field of medical devices, and in particular to a recyclable spiral balloon stent.
背景技术Background technique
随着医学治疗模式的改变以及人们生活水平的提高，疾病的种类及发病频率也出现了明显的不同，尤其是血管疾病的发病率呈现出逐年上升的趋势。传统的血管外科手术方式，通过直接切开病变血管的方式来达到治疗血管疾病的目的，由于血管疾病的病人多数为年老的患者，其身体状况往往较为虚弱，难以承受传统的血管外科手术带来的巨大手术创伤，所以近年来，血管疾病的治疗方式已从传统的血管外科手术方式向微创的腔内血管治疗方式转变，例如，上世纪九十年代开始在国际上逐步推行的经皮穿刺血管成形术PTA(Percutaneous Transluminal Angiography)，即在医学影像设备的引导下，通过小切口，经血管腔内送入特制的血管支架，用于治疗血管的疾病，达到与外科切开手术一样的治疗效果，而且可以大大减少出血和并发症，缩短恢复时间。With the change of medical treatment mode and the improvement of people's living standards, the types and frequency of diseases have also shown obvious differences, especially the incidence of vascular diseases has shown an increasing trend year by year. Traditional vascular surgery is to achieve the purpose of treating vascular diseases by directly cutting the diseased blood vessels. Since most patients with vascular diseases are elderly patients, their physical condition is often weak and it is difficult for them to withstand the huge surgical trauma caused by traditional vascular surgery. Therefore, in recent years, the treatment of vascular diseases has shifted from traditional vascular surgery to minimally invasive intravascular treatment. For example, the percutaneous transluminal angioplasty (PTA) that has been gradually promoted internationally since the 1990s is to deliver a special vascular stent into the blood vessel cavity through a small incision under the guidance of medical imaging equipment to treat vascular diseases, achieving the same treatment effect as surgical incision, and can greatly reduce bleeding and complications, and shorten recovery time.
但随着治疗后随访时间的延长以及治疗范围、难度的逐步扩大，支架植入后中远期出现的支架内再狭窄、闭塞，支架断裂等问题也日益受到人们关注。并且，部分患者存在较高的再次治疗率，支架的长期存在也给再次治疗带来困难。植入支架的益处主要体现在早期血管管腔的维持，当管腔重塑建立后，支架在血管中的持续存在反而成为了影响管腔通畅的不利因素。因此，设计一款便于回收的血管支架有着重要的临床意义。However, with the extension of follow-up time after treatment and the gradual expansion of the scope and difficulty of treatment, problems such as in-stent restenosis, occlusion, and stent fracture in the mid- and long-term after stent implantation have also attracted increasing attention. In addition, some patients have a high rate of re-treatment, and the long-term presence of stents also makes re-treatment difficult. The benefits of stent implantation are mainly reflected in the maintenance of the vascular lumen in the early stage. When the lumen remodeling is established, the continued presence of the stent in the blood vessel becomes an unfavorable factor affecting the patency of the lumen. Therefore, designing a vascular stent that is easy to recycle has important clinical significance.
发明内容Summary of the invention
本发明的目的在于克服以上不足，提供一种可回收的螺旋球囊支架。The purpose of the present invention is to overcome the above disadvantages and provide a recyclable spiral balloon stent.
本发明所采用的技术方案如下：The technical solution adopted by the present invention is as follows:
一种可回收的螺旋球囊支架，其特征在于，包括：球囊，充盈后的所述球囊为螺旋状，所述球囊两端的层间距不大于中间段，以在所述球囊两端提供更高的支撑力；充盈导管，所述充盈导管包括充盈腔，所述充盈导管位于所述球囊的侧边，以使血流更加通畅；支撑丝，所述支撑丝一端为螺旋状，位于所述球囊内部，所述支撑丝尾端设置有平直段，所述平直段延伸至所述充盈导管内部，提高了所述充盈导管的抗打折能力；装载套管，使用前所述球囊以长条状放置于所述装载套管内；A recyclable spiral balloon stent, characterized in that it comprises: a balloon, wherein the balloon is spiral after being filled, and the interlayer distance between the two ends of the balloon is not greater than that of the middle section, so as to provide a higher support force at the two ends of the balloon; a filling catheter, wherein the filling catheter comprises a filling cavity, and the filling catheter is located at the side of the balloon, so as to make the blood flow smoother; a support wire, wherein one end of the support wire is spiral and is located inside the balloon, and a straight section is provided at the tail end of the support wire, and the straight section extends into the filling catheter, so as to improve the anti-bending ability of the filling catheter; a loading sleeve, wherein the balloon is placed in the loading sleeve in a long strip before use;
所述球囊在输送鞘管中为长条状，释放出鞘管后，在所述支撑丝弹性的作用下所述球囊变为螺旋状，然后对所述球囊充盈以提高其支撑性能，螺旋状的结构提供了更高的柔顺性，放置达到预期时间后，对所述球囊泄压，然后通过所述充盈导管拉出体外。The balloon is in the shape of a long strip in the delivery sheath. After being released from the sheath, the balloon becomes spirally shaped under the action of the elasticity of the supporting wire, and then the balloon is filled to improve its supporting performance. The spiral structure provides higher flexibility. After being placed for the expected time, the balloon is depressurized and then pulled out of the body through the filling catheter.
优选的，位于所述球囊内部的所述支撑丝两端设置有不透射线标记点。Preferably, radiopaque marking points are provided at both ends of the support wire located inside the balloon.
优选的，所述球囊中充盈的物质为气体或液体。Preferably, the substance filled in the balloon is gas or liquid.
优选的，所述球囊表面设置有微孔，用于缓慢释放充盈到所述球囊中的物质。Preferably, micropores are provided on the surface of the balloon for slowly releasing the substance filled in the balloon.
优选的，所述支撑丝的材质为镍钛合金或弹性高分子材料。Preferably, the support wire is made of nickel-titanium alloy or elastic polymer material.
优选的，所述支撑丝为实芯丝。Preferably, the support wire is a solid wire.
优选的，所述支撑丝为管状丝。Preferably, the support wire is a tubular wire.
优选的，所述支撑丝的螺旋段表面设置有用于充盈的微孔。Preferably, the surface of the spiral segment of the support wire is provided with micropores for filling.
优选的，所述球囊的材质为聚醚酰胺弹性体、尼龙、聚氨酯、聚酯、聚酰氨化合物中的至少一种。Preferably, the material of the balloon is at least one of polyetheramide elastomer, nylon, polyurethane, polyester, and polyamide compound.
优选的，所述球囊表面涂敷有雷帕霉素、紫杉醇及其衍生物中的至少一种。Preferably, the surface of the balloon is coated with at least one of rapamycin, paclitaxel and their derivatives.
附图说明BRIEF DESCRIPTION OF THE DRAWINGS
图1 一种可回收的螺旋球囊支架，即本发明；FIG1 is a recyclable spiral balloon stent, i.e., the present invention;
图2 一种可回收的螺旋球囊支架的一种实施例；FIG2 is an embodiment of a retrievable spiral balloon stent;
图3 一种可回收的螺旋球囊支架在装载套管中的状态；Figure 3 A retrievable spiral balloon stent in a loading sleeve;
图4 球囊支架的不透射线标记点。Figure 4 Radiopaque marking points of the balloon stent.
具体实施方式Detailed ways
下面结合附图和实施例对本发明的实施方式作进一步详细描述。以下实施例用于说明本发明，但不能用来限制本发明的范围。The following embodiments of the present invention are described in further detail in conjunction with the accompanying drawings and examples. The following examples are used to illustrate the present invention, but are not intended to limit the scope of the present invention.
一种可回收的螺旋球囊支架，其特征在于，包括：球囊100，充盈后的所述球囊100为螺旋状，所述球囊100两端的层间距不大于中间段，以在所述球囊100两端提供更高的支撑力；充盈导管200，所述充盈导管200包括充盈腔210，所述充盈导管200位于所述球囊100的侧边，以使血流更加通畅；支撑丝300，所述支撑丝300一端为螺旋状，位于所述球囊100内部，所述支撑丝300尾端设置有平直段，所述平直段延伸至所述充盈导管200内部，提高了所述充盈导管200的抗打折能力；装载套管400，使用前所述球囊100以长条状放置于所述装载套管400内；A recyclable spiral balloon stent, characterized in that it comprises: a balloon 100, wherein the balloon 100 after being filled is spiral-shaped, and the interlayer distance between the two ends of the balloon 100 is not greater than the middle section, so as to provide a higher support force at the two ends of the balloon 100; a filling catheter 200, wherein the filling catheter 200 comprises a filling cavity 210, and the filling catheter 200 is located at the side of the balloon 100, so as to make the blood flow more unobstructed; a supporting wire 300, wherein one end of the supporting wire 300 is spiral-shaped and is located inside the balloon 100, and a straight section is provided at the tail end of the supporting wire 300, and the straight section extends to the inside of the filling catheter 200, so as to improve the anti-bending ability of the filling catheter 200; a loading sleeve 400, wherein the balloon 100 is placed in the loading sleeve 400 in a long strip before use;
所述球囊100在输送鞘管中为长条状，释放出鞘管后，在所述支撑丝300弹性的作用下所述球囊100变为螺旋状，然后对所述球囊100充盈以提高其支撑性能，螺旋状的结构提供了更高的柔顺性，放置达到预期时间后，对所述球囊100泄压，然后通过所述充盈导管200拉出体外，球囊100的放置时间为几小时、几天、几周或1个月。The balloon 100 is in the shape of a long strip in the delivery sheath. After being released from the sheath, the balloon 100 becomes spiral under the elastic action of the support wire 300, and then the balloon 100 is filled to improve its support performance. The spiral structure provides higher flexibility. After being placed for the expected time, the balloon 100 is depressurized and then pulled out of the body through the filling catheter 200. The balloon 100 is placed for several hours, days, weeks or 1 month.
所述球囊100为异形球囊，在没有支撑丝300的情况下，球囊100在充盈状态下也为螺旋状，所述支撑丝300的作用主要是为了方便球囊100在输送鞘管中的输送，不然球囊100在输送鞘管中运动时很容易打折，另一方面，支撑丝300可以在球囊100刚刚被输送出输送鞘管后做一个初步的定型，使得随后对球囊100进行充盈时，球囊100的扩张更加稳定，不会扰乱血流。The balloon 100 is a special-shaped balloon. In the absence of the support wire 300, the balloon 100 is also spiral-shaped when filled. The main function of the support wire 300 is to facilitate the delivery of the balloon 100 in the delivery sheath, otherwise the balloon 100 is easily bent when moving in the delivery sheath. On the other hand, the support wire 300 can be used to make a preliminary shaping of the balloon 100 just after it is delivered out of the delivery sheath, so that when the balloon 100 is subsequently filled, the expansion of the balloon 100 is more stable and will not disrupt blood flow.
所述球囊100两端的层间距不大于中间段。在一种实施例中，球囊100两端的层间距小于中间段，也就是说螺旋球囊两端更密，可以提供更强的支撑力，防止球囊支架发生位移，而中间较稀疏的部分可以提供更好的柔顺性，因为弹簧结构更加柔顺，所以弹簧球囊100可以被放置在更加曲折的血管中。在另一种实施例中，球囊100两端的层间距等于中间，在这种情况下球囊100的每层是相互贴合的，也就是每层之间没有缝隙，层间距为零，每层之间没有间隙可以阻止血管组织向支架内部生长，减小支架内狭窄的发生。球囊100的顶端也可以为一个封闭的环形，如图2，这样可以提供更强的支撑性，更好的抗位移能力。The interlayer spacing at both ends of the balloon 100 is not greater than the middle section. In one embodiment, the interlayer spacing at both ends of the balloon 100 is smaller than the middle section, that is, the two ends of the spiral balloon are denser, which can provide stronger support and prevent the balloon stent from displacement, while the sparser part in the middle can provide better compliance, because the spring structure is more flexible, so the spring balloon 100 can be placed in a more tortuous blood vessel. In another embodiment, the interlayer spacing at both ends of the balloon 100 is equal to the middle. In this case, each layer of the balloon 100 fits each other, that is, there is no gap between each layer, the interlayer spacing is zero, and there is no gap between each layer to prevent vascular tissue from growing into the stent and reduce the occurrence of stenosis in the stent. The top of the balloon 100 can also be a closed ring, as shown in Figure 2, which can provide stronger support and better anti-displacement ability.
在没有对球囊100充盈时，支撑丝300也可以起到一定的支撑作用，但支撑丝比较细，对血管内壁的支撑面积有限，所以需要球囊100来提高支架对血管的支撑面积。When the balloon 100 is not inflated, the support wire 300 can also play a certain supporting role, but the support wire is relatively thin and the supporting area for the inner wall of the blood vessel is limited, so the balloon 100 is needed to increase the supporting area of the stent for the blood vessel.
充盈导管200的主要作用是为了对球囊100进行充盈。充盈导管200一端连接在球囊100上，另一端连接在充盈阀上，通过充盈腔310对球囊100进行充盈扩张，所述球囊100充盈的物质为气体或者液体。支撑丝300的存在会影响导引导丝通过充盈导管200，从而增加充盈导管输送过程中打折的风险，所以支撑丝300的螺旋段尾端还设置有平直段，平直段延伸至整个充盈导管200内部，提高了充盈导管200的抗打折能力，位于导管200内部的支撑丝300与充盈腔310平行。The main function of the filling catheter 200 is to fill the balloon 100. One end of the filling catheter 200 is connected to the balloon 100, and the other end is connected to the filling valve. The balloon 100 is filled and expanded through the filling cavity 310. The substance filled with the balloon 100 is gas or liquid. The existence of the support wire 300 will affect the guide wire passing through the filling catheter 200, thereby increasing the risk of bending during the delivery of the filling catheter. Therefore, the tail end of the spiral section of the support wire 300 is also provided with a straight section, which extends to the entire filling catheter 200, thereby improving the anti-bending ability of the filling catheter 200. The support wire 300 located inside the catheter 200 is parallel to the filling cavity 310.
所述充盈导管200设置在所述球囊100的侧边，这种设置可以使血流直接流过球囊100的内部，而不会使充盈导管200扰乱血流。在另一种实施例中，所述充盈导管200设置在所述球囊100的中心轴与侧边之间，因为如果充盈导管200设置在侧边，那么球囊100在血管中放置时，充盈导管200就会贴着血管内壁，可能会发生内皮化，不利于后期的去除，如果充盈导管200设置在球囊100的中心轴与侧边之间，那么球囊100在血管中放置时，充盈导管200与血管内壁就会形成一段距离，防止充盈导管200发生内皮化。The filling catheter 200 is arranged on the side of the balloon 100. This arrangement allows the blood flow to flow directly through the interior of the balloon 100 without disturbing the blood flow. In another embodiment, the filling catheter 200 is arranged between the central axis and the side of the balloon 100. If the filling catheter 200 is arranged on the side, when the balloon 100 is placed in the blood vessel, the filling catheter 200 will stick to the inner wall of the blood vessel, which may cause endothelialization, which is not conducive to the subsequent removal. If the filling catheter 200 is arranged between the central axis and the side of the balloon 100, when the balloon 100 is placed in the blood vessel, the filling catheter 200 will form a distance with the inner wall of the blood vessel, preventing the filling catheter 200 from endothelialization.
在产品使用之前，所述球囊100是以折叠和拉伸的状态被平直的放在装载套管400中，然后使用时，通过装载套管400将球囊100推进输送鞘管。因为球囊100在平直状态下的截面积更小，所以可以使用更小直径的输送鞘管将球囊100输送至更小直径的血管中。Before the product is used, the balloon 100 is placed flat in the loading sleeve 400 in a folded and stretched state, and then when used, the balloon 100 is pushed into the delivery sheath through the loading sleeve 400. Because the cross-sectional area of the balloon 100 is smaller in the flat state, a delivery sheath with a smaller diameter can be used to deliver the balloon 100 to a blood vessel with a smaller diameter.
位于所述球囊内部的所述支撑丝两端设置有不透射线标记点510和520。所述球囊是在X射线下进行输送，所以需要设置不透射线标记点来定位球囊100在血管中的位置，所述标记点的材质为铂铱合金或者黄金。Both ends of the support wire inside the balloon are provided with radiopaque marking points 510 and 520. The balloon is transported under X-rays, so radiopaque marking points need to be provided to locate the position of the balloon 100 in the blood vessel, and the material of the marking points is platinum-iridium alloy or gold.
在一种实施例中，所述球囊表面设置有微孔，用于缓慢释放充盈到所述球囊中的液体。为了防止血管内皮组织的过度增生，所述球囊100中可以充盈雷帕霉素或者紫杉醇等的溶液，溶液可以通过所述微孔缓慢释放，起到抗增生的作用，另外也可以根据实际需求，充盈其他药物。在另一种实施例中，药物是涂敷在所述球囊100的表面，比如涂敷雷帕霉素、紫杉醇及其衍生物中的至少一种时，就可以防止血管内皮组织的过度增生。In one embodiment, the balloon surface is provided with micropores for slowly releasing the liquid filled in the balloon. In order to prevent excessive proliferation of vascular endothelial tissue, the balloon 100 can be filled with a solution of rapamycin or paclitaxel, etc., and the solution can be slowly released through the micropores to play an anti-proliferative role. In addition, other drugs can be filled according to actual needs. In another embodiment, the drug is coated on the surface of the balloon 100, for example, when at least one of rapamycin, paclitaxel and its derivatives is coated, excessive proliferation of vascular endothelial tissue can be prevented.
所述支撑丝的材质为镍钛合金，因为镍钛合金材料拥有超弹性，所以在其被压缩后，可以自扩张到原始形状，这种性质有利于所述球囊100被输送出鞘管后的快速展开。在另一种实施例中，所述支撑丝的材质为高分子材料，如尼龙、聚醚嵌段酰胺(PEBA)、聚对苯二甲酸乙二醇酯(PET)、聚氯乙烯(PVC)、聚酯、聚氨酯、其衍生物或其组合等。The material of the support wire is nickel-titanium alloy. Since nickel-titanium alloy has superelasticity, it can expand to its original shape after being compressed. This property is conducive to the rapid deployment of the balloon 100 after being transported out of the sheath. In another embodiment, the material of the support wire is a polymer material, such as nylon, polyether block amide (PEBA), polyethylene terephthalate (PET), polyvinyl chloride (PVC), polyester, polyurethane, derivatives thereof, or combinations thereof.
所述支撑丝300为实芯丝，实芯丝弹性更好更容易加工。在另一宗实施例中，所述支撑丝300为管状的空芯丝，管状空芯丝中可以通过充盈球囊所需的物质，加快球囊的充盈速度。The support wire 300 is a solid wire, which has better elasticity and is easier to process. In another embodiment, the support wire 300 is a tubular hollow wire, and the tubular hollow wire can be filled with substances required for filling the balloon to accelerate the filling speed of the balloon.
所述球囊100可以由任何合适材料形成，诸如非顺应性或半顺应性生物相容性材料。在一些实施方案中，球囊可以通过吹塑成型来制造。球囊的材质可以为：尼龙(例如任何合适尼龙，诸如尼龙6 ,6或尼龙12)、聚醚嵌段酰胺(PEBA)、聚对苯二甲酸乙二醇酯(PET)、聚氯乙烯(PVC)、聚酯、聚氨酯、其衍生物或其组合。The balloon 100 can be formed of any suitable material, such as a non-compliant or semi-compliant biocompatible material. In some embodiments, the balloon can be manufactured by blow molding. The material of the balloon can be: nylon (e.g., any suitable nylon, such as nylon 6, 6 or nylon 12), polyether block amide (PEBA), polyethylene terephthalate (PET), polyvinyl chloride (PVC), polyester, polyurethane, derivatives thereof, or combinations thereof.
球囊是在模具中吹塑成型的。首先将球囊材料插入具有预期形状的模具中，然后对材料和模具进行加热，并用气体或流体进行加压，使球囊材料变为与模具相同的形状，等球囊冷却后，再与支撑丝装配，就可以连接至导管主体上。The balloon is blow-molded in a mold. The balloon material is first inserted into a mold with the desired shape, and then the material and mold are heated and pressurized with gas or fluid to make the balloon material change to the same shape as the mold. After the balloon cools, it is assembled with the support wire and connected to the catheter body.
所描述的实施方案在所有方面仅被认为是说明性的而不是限制性的。因此，本公开的范围由所附的权利要求而不是由前面的说明书来表示。在权利要求的等同的含义和范围内的所有改变都被包括在其范围内。本发明并不局限于上述实施例，即不意味着本发明必须依赖上述实施例才能实施。所属技术领域的技术人员应该明了，对本发明的任何改进，对本发明所选用原料的等效替换及辅助成分的添加、具体方式的选择等，均落在本发明的保护范围和公开范围之内。The described embodiments are to be considered in all respects as illustrative only and not restrictive. Therefore, the scope of the present disclosure is indicated by the appended claims rather than by the preceding description. All changes within the equivalent meaning and scope of the claims are included within their scope. The present invention is not limited to the above-described embodiments, which does not mean that the present invention must rely on the above-described embodiments to be implemented. Those skilled in the art should understand that any improvements to the present invention, equivalent replacement of the raw materials selected by the present invention, addition of auxiliary components, selection of specific methods, etc., all fall within the scope of protection and disclosure of the present invention.
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