CN102038565B - Great vascular stent delivery system - Google Patents

Great vascular stent delivery system Download PDF

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Publication number
CN102038565B
CN102038565B CN 201010608696 CN201010608696A CN102038565B CN 102038565 B CN102038565 B CN 102038565B CN 201010608696 CN201010608696 CN 201010608696 CN 201010608696 A CN201010608696 A CN 201010608696A CN 102038565 B CN102038565 B CN 102038565B
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China
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tube
handle
pin
delivery system
spring
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CN 201010608696
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Chinese (zh)
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CN102038565A (en
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于学保
许尚栋
缪卫东
朱明�
冯景苏
扈玉玲
李君涛
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北京有色金属研究总院
有研亿金新材料股份有限公司
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Abstract

本发明属于医疗器械领域,特别涉及一种可实现前端后释放功能的大血管支架放送系统。 The present invention is in the field of medical devices, and more particularly to large vessel stent delivery system to release the latter function can be achieved leading end. 从前到后由定位引导头、后释放机构、芯管、中管、外鞘管、大手柄、小手柄以及推送杆几部分组成。 Front to back by the positioning guide head, after the release mechanism, the core tube, the tubes, outer sheath, large handle, the small handle and the pushers of several parts. 整个系统机构简单,操作方便,使用安全有效避免了提前释放及不能释放的现象,并通过将不锈钢芯管局部雕刻为弹簧,在实现了降低芯管直径减小系统尺寸的同时,极大地提高了系统远端的柔顺性,降低了放送过程中系统对血管的损伤。 Means the whole system is simple, easy, safe and effective and avoid the early release of the phenomenon can not be released, and by a partial engraving of a stainless steel spring core tube, achieving a reduced diameter of the core tube while reducing the size of the system, greatly improved the distal end of the compliance of the system, serving to reduce the damage during vascular system.

Description

新型大血管支架放送系统 The new big vessel stent delivery system

技术领域 FIELD

[0001] 本发明属于医疗器械领域,特别涉及一种可实现前端后释放功能的大血管支架放送系统。 [0001] The present invention belongs to the field of medical devices, and more particularly to large vessel stent delivery system to release the latter function can be achieved leading end.

背景技术 Background technique

[0002] 主动脉疾病特别是主动脉瘤是一种严重威胁患者生命,致死率极高的心脏大血管急症。 [0002] In particular aortic aneurysm aortic disease is a serious threat to the lives of patients, a high mortality rate of acute heart and great vessels. 据统计,未治疗者5年死亡率为50%〜76%,而合并心肺疾病者的死亡率高达93%。 According to statistics, untreated 5-year mortality rate was 50% ~76%, while the mortality rate of the combined heart and lung disease by up to 93%. 90年代以前,外科手术是治疗主动脉疾病的主要方法,但是这种手术方法创伤大、手术时间长、并发症多、死亡率高,胸腹主动脉瘤手术死亡率达5%〜26%,截瘫发生率为4.6%。 90 years ago, surgery is the main method of treatment of aortic disease, but this surgical trauma, surgery for a long time, complications and high mortality, abdominal aortic aneurysm surgery mortality rate of 5% ~26% 4.6% incidence of paraplegia. 近年来,随着微创伤介入治疗技术的发展,腔内血管支架隔绝术治疗主动脉疾病得以广泛的应用,这种手术方法具有创伤小、出血少,治疗时间短、疗效好、可重复性治疗等传统外科手术方法无可比拟的优点。 In recent years, with the development of minimally invasive interventional therapy, endovascular stent isolated aortic disease treatment is widely used, this surgical method is less invasive, less bleeding, treatment time is short, effective, repeatable traditional surgical treatment method unparalleled advantages. 即利用血管支架放送器将血管支架送入病变部位,通过血管支架使夹层或瘤腔内的血流消失,形成血栓,此后逐渐吸收或隔绝病变,以达到治疗主动脉疾病的目的。 Namely the use of a vascular stent into a vascular stent will serve lesion, blood flow through the vascular stent or endovascular dissection disappeared, thrombosis, then gradually absorbed or isolated lesions, to achieve the purpose of the treatment of aortic disease.

[0003] 普通放送系统无前端后释放机构,在释放第一段覆膜段时,因为瞬时阻断胸主动脉内血液,使得其内血压骤升,高压血流的冲击使得支架发生不同程度的移位,不能够准确放置在预定位置,部分覆盖分支血管出口,不能很好封堵动脉瘤夹层,使得治疗效果大打折扣。 [0003] Normal delivery system release mechanism without the front section of the coating film upon release of the first stage, due to momentary block the aortic blood, the blood that it swells, so that the impact of high pressure blood flow occurs in varying degrees of stent shift, can not be accurately disposed at a predetermined position, partially covers the outlet branch vessel, an aneurysm is not well plugged dissection, such treatment greatly reduced.

[0004] 为了避免上述问题,国外同类产品大都采用带前端后释放机构的放送系统,效果良好。 [0004] In order to avoid the above problem, mostly using products similar foreign serving system with the release mechanism after the front end, with good results. 代表性产品有C00K、美敦利、JOTEC、RELAY等。 Representative products are C00K, United States Dunli, JOTEC, RELAY and so on. 尤其是RELAY的产品,在实现前端后释放的同时,还实现了支架的分级释放,很好地避免了上述问题的出现。 Especially RELAY product, while realizing after the front end of the release, also achieved a grade-eluting stents, good to avoid the problems mentioned above. 但这些放送系统结构复杂、操作繁琐、放送系统远端柔顺性差、系统直径较大,对血管损伤较大,不适合亚洲人群。 However, these systems run complex structure, complicated operation, poor compliance delivery system, the distal end, a larger diameter systems, large vessel injury, is not suitable for Asian people.

发明内容 SUMMARY

[0005] 本发明的目的是提供一种可实现前端后释放功能的大血管支架放送系统。 [0005] The object of the present invention is to provide a release function can be achieved after large vessels distal stent delivery system. 系统结构简单,在减小系统尺寸的同时,提高系统远端的柔顺性,降低释放过程中系统对血管的损伤。 Simple structure, while reducing the size of the system, to improve the flexibility of the distal end of the system, reduce damage to the system during the release of the vessel.

[0006] 为实现上述目的,本发明采取以下设计方案: [0006] To achieve the above object, the present invention adopts the following design:

[0007] 该大血管支架放送系统,从前到后由定位引导头、后释放机构、芯管、中管、外鞘管、大手柄、小手柄以及推送杆几部分组成。 [0007] The large vessel stent delivery system, from front to back by the positioning guide head, after the release mechanism, the core tube, the tubes, outer sheath, large handle, the small handle and the pushers of several parts.

[0008] 所述后释放机构由带有中心通孔的销钉座和五角星连接件组成,销钉座的前端通过螺纹与所述定位引导头连接;五角星连接件沿圆周方向均匀分布5个销钉孔,销钉座上沿圆周方向均匀固定与所述销钉孔一一对应的5个销钉;所述芯管由两根前端为弹簧的粗弹簧管和细弹簧管组成,细弹簧管位于粗弹簧管内;后释放机构后端通过五角星连接件的中心通孔内壁与粗弹簧管的前端固定连接,细弹簧管的前端穿过粗弹簧管与销钉座的中心通孔内壁固定连接;所述细弹簧管可带动销钉座及销钉在五角星连接件的销孔内往复移动;五角星连接件的中部设置凹槽,使得大曲管支架的5个裸端可嵌入其中,并被插入销孔的5根销钉限制于凹槽内,实现对大血管支架裸端的限制与释放。 [0008] After the release mechanism comprises a pin-pointed star and a base member connected with a central through hole of the composition, the front end of pin holder threadably connected with the positioning guide head; pentagram connecting member evenly distributed in the circumferential direction of the pin 5 hole, the pin seat holes uniformly fixed one to one correspondence with the pin 5 in the circumferential direction of the pin; the distal end of the core tube by the two coarse and fine spring tube spring tubes spring, wire spring tube is positioned within the spring tube crude ; after releasing the rear tip of the tip mechanism through the through-hole inner wall is fixedly connected to the central five-pointed star with the connecting member of the spring tube rough, thin spring tube central through-hole inner wall is fixedly connected through a tube with the spring pin crude base; said hairspring tube may be connected to drive pin base and the pin hole of the pin member to reciprocate in pentagram; pentagram central connecting member is provided a recess, so that the end of the five bare stent may Okuma embedded therein, and the pin insertion hole 5 limit pin in the groove, limitations and achieve the release of the large end of the bare stent.

[0009] 所述中管与所述粗弹簧管的后端通过螺纹连接或热合连接,且向后延伸依次穿过外鞘管、大手柄,伸入小手柄内固定。 [0009] The rear end of the tube and the tube is fixed by a spring coarse threaded connection or connections heat, and extends rearwardly through the outer sheath in turn, a large handle, the handle extending into small.

[0010] 所述外鞘管套装于中管外,后端与大手柄固定连接;在外鞘管的前端设置Pt/Ir金属显影环,在手术过程中显示放送系统在体内到达的确切位置。 [0010] The outer tube is fitted in an outer sheath tube, connected to the rear end of the fixed handle large; distal outer sheath disposed Pt / Ir metal rings developer, show the exact location of the delivery system arrives in vivo during surgery.

[0011] 所述大手柄内部为前后贯通的长孔,中后段侧壁上伸出一细管与带有三通连接件的延长管连接,液体可通过三通连接件及延长管流入大手柄的内孔从而流入外鞘管与中管之间;大手柄后端设置硅胶密封圈和旋紧螺母,通过旋紧螺母挤压密封圈,从而压紧中管,达到固定中管及密封的作用。 [0011] The inside handle large long hole penetrating the front and rear, a thin tube extending on the rear sidewall section with an extension tube connected to a three-way connector, the liquid flows into the large tube can be connected to the handle member and the extension of the three-way the bore thus flows between the outer sheath and the middle tube; rear handle large silicone ring is provided and tighten the nut, the sealing ring pressed by tightening the nut, thereby compressing the tube, and the tube is fixed to the role of sealing .

[0012] 所述小手柄的前端通过柄体与中管连接固定,后端通过推送杆与细弹簧管的后端连接固定;小手柄末端管口处设置推送螺母和锁紧螺钉,所述推送杆与推送螺母之间采用螺纹配合。 [0012] The front end of the handle through the small handle is connected with the tube fixing member, connected to the rear end of the rear end of the push rod is fixed by a wire spring tube; small handle is provided at the end of the spout push nut and the locking screw, the push threaded engagement between the push rod and the nut.

[0013] 所述定位引导头由包括PEBAX、PE、PU、PEEK、PP在内的医用塑料制成,硬度为20〜50D,外表光滑,用于将系统导入血管内。 [0013] The head positioning guide made of medical grade plastics include PEBAX, PE, PU, ​​PEEK, PP, including, hardness 20~50D, smooth appearance for the endovascular system lead.

[0014] 所述销钉座及五角星连接件由高硬度POM、PEBAX医用塑料或不锈钢制成,所述销钉由不锈钢丝或钛镍记忆合金丝制成。 [0014] The base of the pin connector and a five-pointed star made of a high hardness POM, PEBAX medical plastic or stainless steel, said stainless steel wire or pin is made of nickel titanium memory alloy wire.

[0015] 所述外鞘管为三层材质挤压结合在一起的管子,外层为PEBAX医用塑料,中间为不锈钢扁丝编织成的网状加强筋,内层为PTFE,内表面光滑,总体壁厚为0.1〜0.3mm。 [0015] The outer sheath material is extruded together three tubes, medical plastic PEBAX outer layer, an intermediate reinforcing stainless steel braided flat wire mesh reinforcement, the inner layer is PTFE, a smooth inner surface, the overall wall thickness 0.1~0.3mm.

[0016] 所述芯管为不锈钢材质,选用医用级304、316或316L不锈钢。 [0016] The core tube of stainless steel, or a selection of medical grade 316L stainless steel 304,316.

[0017] 所述中管由包括PEBAX、PE、PU、PEEK、PP在内的医用塑料制成,硬度为30〜70D。 [0017] The medical tube is made of plastics include PEBAX, PE, PU, ​​PEEK, PP, including, hardness 30~70D.

[0018] 所述小手柄的材质为包括P0M、PVC、PP在内的医用塑料。 [0018] The handle is made of include small P0M, PVC, PP, including medical plastic.

[0019] 本发明的优点是: [0019] The advantage of the present invention are:

[0020] 1、后释放机构实现了大血管支架的前端后释放避免了因瞬时阻断主动脉内血液导致的支架发生移位不能够准确放置的弊端。 [0020] 1, after the release mechanism after the front end of the drawbacks to achieve a large vessel stent does not shift to avoid the release of accurate placement of aortic stent momentary blocking occurs due to the blood. 后释放机构结构紧凑,在血管内运动时光滑安全。 After the release mechanism structure compact, safe and smooth movement within the blood vessel. 机构与定位引导头通过螺纹连接并粘结,牢固可靠。 Positioning the guide mechanism and is bound by a threaded connector, solid and reliable.

[0021] 2、芯管由两根局部雕刻成弹簧的不锈钢弹簧管一粗弹簧管和细弹簧管组成。 [0021] 2, the core tube by the two partial springs carved into a crude tube of stainless steel spring wire spring spring tube and tubes. 不锈钢管的抗拉强度高,在保证安全性的同时,可以减小壁厚,减小系统整体直径,从而减小放送系统对血管的创伤。 High tensile strength stainless steel pipe, while ensuring security, the wall thickness can be reduced, reducing the overall diameter of the system, thereby serving to reduce the trauma to the blood vessel system. 将不锈钢管局部雕刻成弹簧,可以大大增加系统的柔顺性,避免手术中对血管的损伤。 The stainless steel tube partially carved into the spring, can greatly increase the flexibility of the system, to avoid damage to the blood vessel surgery.

[0022] 3、所述外鞘管为三层材质挤压结合在一起的管子。 [0022] 3, the outer sheath material of a three-layer extruded tube together. 外鞘管内壁的PTFE材质表面光滑,与中管的摩擦系数低,使得推送支架时阻力较小;网状加强筋使得外鞘管壁厚较小的同时有足够的刚性及强度,不易被其内的大血管支架撑变形,不易在推送支架过程中被拉变形或拉断,不易在血管内弯曲时出现死折而导致支架无法释放。 PTFE material of the inner wall surface of the outer sheath smooth, low coefficient of friction in the tube, so that less resistance when pushing the stent; web stiffeners made small thickness while the outer sheath has sufficient rigidity and strength, which can not easily be large vessel stent struts deformed, or deformed easily pulled to pull off the holder during the push, when dead fold less flexible the stent within the vessel can not lead to the release. 既降低了系统的整体尺寸又保证了系统的安全性。 Not only reduces the overall size of the system and ensure the security of the system. 外鞘管前端有一Pt/Ir金属显影环,在手术过程中显示放送系统在体内到达的确切位置,实现对支架的准确定位。 An outer sheath having a distal Pt / Ir metal rings developer, show the exact location of the delivery system arrives in vivo during surgery, to achieve accurate positioning of the stent.

[0023] 4、小手柄较同类产品结构简单紧凑,操作简便、使用安全。 [0023] 4, the small handle than similar products simple and compact structure, easy to operate, safe to use. 顺时针旋转推送螺母,推送杆带动细弹簧管、销钉座、5根销钉后撤,锁住大血管支架的5个裸端后,旋紧锁紧螺钉,可防止在运输过程中或手术中误操作而使推送螺母转动从而导致后释放机构提前释放。 Push nut rotates clockwise, push rod driven hairspring tube, pin base, the pin 5 retreat, the large vessel stent locked five bare end, tightening the locking screw to prevent false during transport or surgery operating the push nut so that rotation of the release mechanism resulting in early release. 逆时针旋转推送螺母,推送杆带动细弹簧管、销钉座、5根销钉前推,可实现后释放机构的平稳解锁。 Push nut rotates counterclockwise, the push rod drives hairspring tube, seat pin, push pin 5 before, after unlocking can achieve a smooth release mechanism.

[0024] 5、锁紧状态下,放送系统推入血管发生弯曲时,粗细不锈钢管因弯曲而产生的轴向拉力和压力全部转换为粗细不锈钢弹簧管的弹性可恢复变形,而避免了五角星与粗弹簧管的连接处及销钉座与细不锈钢管的连接处因应力过大而脱落,也避免了芯管整体的不易变形。 When the [0024] 5, a locked state is pushed into the vascular system serving bent, axial tension and pressure stainless steel pipe thickness generated due to bending is converted into the thickness of the entire tube of stainless steel spring elastically recoverable deformation is avoided pentagram crude spring tube connections and connections of the pin holder and the thin stainless steel pipe and fall off due to excessive stress, deformation of the core also avoids difficult whole tube.

[0025] 6、机构简单,操作方便,使用安全,有效避免了提前释放及不能释放的现象。 [0025] 6, simple mechanism, easy to operate, safe, effective and can not avoid the early release release phenomenon.

附图说明 BRIEF DESCRIPTION

[0026] 图1为所述放送系统整体结构示意图; [0026] FIG. 1 is a schematic view of the overall structure of the delivery system;

[0027] 图2为后释放机构示意图; [0027] FIG. 2 is a schematic view of the release mechanism;

[0028] 图3(a)和图3(b)分别为后释放机构中五角星连接件半剖图和俯视图; [0028] FIG. 3 (a) and 3 (b) five-pointed star in a half-sectional view of the mechanism after releasing the connections and plan view, respectively;

[0029] 图4为大手柄结构示意图; [0029] FIG. 4 is a schematic structural diagram of a large handle;

[0030] 图5为小手柄结构示意图; [0030] FIG. 5 is a schematic small handle structure;

[0031] 图6(a)为放送系统工作时,血管支架收紧状态的示意图; When [0031] FIG. 6 (a) serving as a working system, vascular stents schematic tightened state;

[0032] 图6(b)为放送系统工作时,血管支架推出状态的示意图; When [0032] FIG. 6 (b) serving as a working system, showing a state of a vascular stent introduced;

[0033] 图6(c)为放送系统工作时,血管支架释放状态的示意图。 When [0033] FIG. 6 (c) serving as a working system, vascular stents released state of FIG.

[0034] 图中标号: [0034] FIG numeral:

[0035] 1-导丝;2_定位弓丨导头;3_后释放机构;4_芯管;5_中管;6_外鞘管; [0035] 1- guidewire; 2_ guide head positioning arch Shu; 3_ after release mechanism; 4_ core tube; 5_ tube; 6_ outer sheath;

[0036] 7-大手柄;8_延长管;9_密封圈;10-中管;11-小手柄;12_锁紧螺钉; [0036] 7- big handle; 8_ extension pipe; 9_ ring; 10- pipe; 11- small handle; 12_ locking screw;

[0037] 13-推送杆;14_螺母;15_推送螺母;17_销钉座;18_五角星连接件;19_销钉; [0037] 13- pushers; 14_ nut; 15_ push nut; 17_ dowel cup; 18_ pointed star connection; 19_ pins;

[0038] 20-粗弹簧管;21_细弹簧管;22_柄体;23_大血管支架;24_凹槽。 [0038] The crude spring tube 20; thin spring tube 21_; a 22 handle body; 23_ large vessel stent; 24_ recess.

具体实施方式 Detailed ways

[0039] 本发明提供了一种大血管支架放送系统,下面结合附图和具体实施方式对本发明做进一步说明。 [0039] The present invention provides a large vessel stent delivery system of the present invention, the following further description and specific embodiments in conjunction with the accompanying drawings.

[0040] 如图1所示,该放送系统从前到后由定位引导头2、后释放机构3、芯管4、中管5、外鞘管6、大手柄7、小手柄11以及推送杆13几部分组成。 [0040] As shown in FIG. 1, the system is served by the front to back positioning guide head 2, the release mechanism 3, the core tube 4, the tube 5, the outer sheath 6, a large handle 7, the handle 11 and the small push rod 13 several parts.

[0041] 其中,如图2和图3所示,所述后释放机构2由带有中心通孔的销钉座17和五角星连接件18组成,销钉座17的前端通过螺纹与所述定位引导头2连接;五角星连接件18沿圆周方向均匀分布5个销钉孔,销钉座17上沿圆周方向均匀固定与所述销钉孔一一对应的5个销钉19 ;所述芯管4由两根前端为弹簧的粗弹簧管20和细弹簧管21组成,细弹簧管21位于粗弹簧管20内;后释放机构2后端通过五角星连接件18的中心通孔内壁与粗弹簧管20的前端固定连接,细弹簧管21的前端穿过粗弹簧管20与销钉座17的中心通孔内壁固定连接;所述细弹簧管21可带动销钉座17及销钉19在五角星连接件18的销孔内往复移动;五角星连接件18的中部设置凹槽24,使得大血管支架的5个裸端可嵌入其中,并被插入销孔的5根销钉限制于凹槽内,实现对大血管支架裸端的限制与释放。 [0041] wherein, as shown in FIGS. 2 and 3, the release mechanism 2 are connected by a rear seat 17 and the pin-pointed star with a central through hole 18 composed of the front end of pin holder 17 through the positioning threaded guide connecting head 2; pentagram connecting member 18 evenly distributed in the circumferential direction of the five pin holes, uniformly with the fixing pin hole 19 correspond to the pins 5 in the circumferential direction on the pin holder 17; the core tube 4 by the two the front end of a spring 20 and a spring tube thick tube 21 composed of a wire spring, wire spring 21 is located within the tube 20 rough spring tube; after release mechanism 2 through the front center of the rear end-pointed star connecting member 18 and the inner wall of the through-hole 20 of the spring tube crude fixedly connected, tapered spring tube 21 through the center of spring tube 20 and the thick pin seat 17 of the inner wall of the through hole is fixed; said thin tube spring 21 can drive the pin 17 and pin 19 seat member 18 is connected to pin holes in the pentagram the traverse; central member 18 is provided a recess 24 connected to the five-pointed star, so that the large end of the five bare stent can be embedded therein, and the pin insertion hole 5 of the pin in the groove to limit, to achieve the great vessels of the bare stent end restrictions and released.

[0042] 所述中管5与所述粗弹簧管20的后端通过螺纹连接或热合连接,且向后延伸依次穿过外鞘管6、大手柄7,伸入小手柄11内固定。 A rear end [0042] of the tube 5 and the spring tube 20 by a coarse threaded connection or heat sealing, extending rearwardly and passes through the outer sheath 6, a large handle 7, the fixed handle 11 projects into small.

[0043] 所述外鞘管6套装于中管5外,后端与大手柄7固定连接;在外鞘管6的前端设置Pt/Ir金属显影环,在手术过程中显示放送系统在体内到达的确切位置。 [0043] The outer sheath 6 set to 5, the rear end of the handle 7 is fixedly connected with the large tube; distal outer sheath disposed Pt / Ir metal ring 6 of the developing display system serving during surgery arrived in vivo exact location.

[0044] 如图4所示,所述大手柄7内部为前后贯通的长孔,中后段侧壁上伸出一细管与带有三通连接件的延长管8连接,液体可通过三通连接件及延长管8流入大手柄7的内孔从而流入外鞘管6与中管5之间;大手柄7后端设置硅胶密封圈9和旋紧螺母14,通过旋紧螺母14挤压密封圈9,从而压紧中管5,达到固定中管及密封的作用; [0044] As shown, the elongated hole 7 inside the front and rear handle large therethrough, a projecting thin tube 8 is connected with the extension pipe tee fitting with the posterior segment of the side walls 4, the three-way liquid connecting member and the extension tube 8 flows into the large hole of the handle 7 so that between the pipe 6 into the outer sheath and the middle tube 5; large handle 7 disposed the rear end of the silicone ring 9 and tighten the nut 14, the nut 14 by tightening pinch seal ring 9, thereby pressing the tube 5, to effect a seal and the fixed tube;

[0045] 如图5所示,所述小手柄11的前端通过柄体与中管5连接固定,后端通过推送杆13与细弹簧管21的后端连接固定;小手柄11末端管口处设置推送螺母15和锁紧螺钉12,所述推送杆13与推送螺母15之间采用螺纹配合。 [0045] As shown in FIG. 5, the front end of the small handle through the handle body 11 is connected to the fixed tube 5, the rear end of the spring 13 is connected to the rear end of the thin tube 21 is fixed by a push rod; small spout at the end of the handle 11 setting a push nut 15 and locking screw 12, the push rod 13 and the threaded engagement between the push nut 15.

[0046] 所述定位引导头2由医用塑料PEBAX制成,硬度为30D,外表光滑;所述销钉座17及五角星连接件18由高硬度医用塑料POM制成;所述销钉19由钛镍记忆合金丝制成;所述外鞘管6为三层材质挤压结合在一起的管子,外层为PEBAX医用塑料,中间为不锈钢扁丝编织成的网状加强筋,内层为PTFE,内表面光滑,总体壁厚为0.2mm ;所述芯管4为不锈钢材质,选用医用级316不锈钢;所述中管5由医用塑料制成,硬度为50D ;所述小手柄11的材质为包括医用塑料PVC。 [0046] The head positioning guide 2 is made of a medical plastic PEBAX, hardness of 30D, a smooth exterior; and a base 17 of the pin-pointed star connecting member 18 made of a high hardness of the POM plastic medical; and the pins 19 of nickel titanium memory alloy wire is made of; the outer sheath 6 is extruded three-layer material bonded together tubes, medical plastic outer layer of PEBAX, an intermediate flat wire braided stainless steel mesh reinforcing ribs, the inner layer is PTFE, the smooth surface, the overall wall thickness of 0.2mm; the core tube 4 made of stainless steel, 316 stainless steel, medical grade selection; the middle tube 5 made of medical grade plastic, hardness 5OD; material of the handle 11 to include a small medical plastic PVC.

[0047] 使用该放送系统时,按如下程序操作: [0047] When the delivery system is used, the operation according to the following procedure:

[0048] (I)术前,将大血管支架23的5个裸端可嵌入五角星连接件18的环形凹槽24内并顺时针旋转推送螺母15,使推送杆13带动细弹簧管21、销钉座17、5根销钉19后撤,锁住大血管支架23的5个裸端后,旋紧锁紧螺钉12,支架的5个裸端被5根销钉限制于凹槽内。 [0048] The front (I) operation, the bare end of the five large vessel stent 23 may be five-pointed star connection fitted in the annular groove 24 and the member 18 rotates clockwise push nut 15, so that the push rod 13 driven by thin spring tube 21, 17,5 root pin holder pins 19 retreat, after the bare end of the lock 5 of the large vessel stent 23, tightening the locking screw 12, the holder 5 is limited to the bare end of the recess 5 pins. 将大血管支架23压缩后塞入外鞘管6内,支架装配完毕,如图6(a)所示。 After the large vessel stent 23 compressed within tube 6 inserted into the outer sheath, the stent assembled, FIG. 6 (a) shown in FIG.

[0049] (2)将导丝I插入血管至合适位置。 [0049] (2) a guide wire into the blood vessel into position I.

[0050] (3)将装好支架的大血管放送系统沿导丝插入血管至合适位置。 [0050] (3) The large vessel stent installed serving system into the blood vessel along the guide wire to the appropriate position.

[0051] (4)旋松螺母14,握住小手柄11不动(此时中管5、芯管4、后释放机构3、定位引导头2及大血管支架均不动),后撤大手柄7带动外鞘管6后移,被压缩于外鞘管内的支架被逐级释放,此时支架裸端仍被限制于后释放机构3内,如图6(b)所示。 [0051] (4) Loosen the nut 14, holds the handle 11 does not move small (in this case the tube 5, the core tube 4, the release mechanism 3, the first positioning guide 2 and the large vessel stent not move), a large retreat 7 to drive the outer sheath handle 6 after shift, the stent is compressed within the outer sheath is progressively released, then the bare end of the stent is still confined within the release mechanism 3, as shown in Figure 6 (b).

[0052] (5)在血管内微调支架至合适位置。 [0052] (5) trimming the bracket to a suitable position within the vessel.

[0053] (6)握住小手柄11不动,旋掉锁紧螺钉12,逆时针旋转推送螺母15,推送杆带动细弹簧管、销钉座、5根销钉前移,销钉从五角星的销钉孔撤出,支架5个裸端因自身弹性从五角星连接件18的环形凹槽24内弹出。 [0053] (6) holding the small lever 11 does not move, spin off the locking screw 12, the push nut 15 rotates counterclockwise, the push rod drives hairspring tube, pin base, the pin 5 forward, the pin of the pin from the pentagram withdrawal hole, the bare end of the holder 5 due to its own elastic member 18 connected to the annular groove 24 from the pop-pointed star. 至此,支架被完全释放,如图6(c)所示。 At this point, the stent is fully released, FIG. 6 (c) shown in FIG.

[0054] (7)握住大手柄7不动,后撤小手柄11,带动中管5、芯管4、后释放机构3、定位引导头2—起回收至外鞘管6内。 [0054] (7) holding a large handle 7 does not move, withdraw small handle 11, drive tube 5, the core tube 4, the release mechanism 3, the head positioning guide 2- recovered from the outer to the inner sheath 6.

[0055] (8)锁紧螺母4。 [0055] (8) 4 locknut.

[0056] (9)握住大手柄7,将整个放送系统沿导丝撤出血管,手术完成。 [0056] (9) holding a large handle 7, the entire delivery system withdrawn over the guidewire vessel, the procedure is complete.

Claims (8)

1.一种大血管支架放送系统,从前到后由定位引导头(2)、后释放机构(3)、芯管(4)、中管(5)、外鞘管¢)、大手柄(7)、小手柄(11)以及推送杆(13)几部分组成,其特征在于, 所述后释放机构⑶由带有中心通孔的销钉座(17)和五角星连接件(18)组成,销钉座(17)的前端通过螺纹与所述定位引导头(2)连接;五角星连接件(18)沿圆周方向均匀分布5个销钉孔,销钉座(17)上沿圆周方向均匀固定与所述销钉孔一一对应的5个销钉(19);所述芯管(4)由两根前端为弹簧的粗弹簧管(20)和细弹簧管(21)组成,细弹簧管(21)位于粗弹簧管(20)内;后释放机构(3)后端通过五角星连接件(18)的中心通孔内壁与粗弹簧管(20)的前端固定连接,细弹簧管(21)的前端穿过粗弹簧管(20)与销钉座(17)的中心通孔内壁固定连接;所述细弹簧管(21)可带动销钉座(17)及销钉(19)在五角星连接件(18)的销钉孔内往复移动;五 A large vessel stent delivery system, from front to back by a positioning guide head (2), after the release mechanism (3), the core tube (4), tube (5), the outer sheath ¢), big handle (7 ), small handle (11) and a push rod (13) of several parts, characterized in that, after the release mechanism ⑶ a dowel cup with a central through hole (17) and a five-pointed star connection (18), with the pin seat (17) by a threaded front end of the positioning guide head (2) is connected; pentagram connecting member (18) uniformly distributed in the circumferential direction of the pin hole 5, and the fixing pin seat evenly in the circumferential direction (17) 5 one to one pin hole pins (19); the core tube (4) consists of two thick distal spring tube spring (20) and a thin spring tube (21) composed of thin spring tube (21) positioned crude spring tube (20); the front end of the release mechanism (3) connected to the rear end through the front end of the central five-pointed star member (18) of the inner wall of the through hole crude spring tube (20) is fixedly connected, thin spring tube (21) passing through the crude center spring tube (20) and a pin seat (17) fixed to the inner wall of the through hole; said thin tube spring (21) can be driven by a pin seat (17) and a pin (19) in a five-pointed star connection pin (18) bore to reciprocate; Fifth 星连接件(18)的中部设置凹槽(24),使得大血管支架的5个裸端可嵌入其中,并被插入销钉孔的5根销钉限制于凹槽内,实现对大血管支架裸端的限制与释放; 所述中管(5)与所述粗弹簧管(20)的后端通过螺纹连接或热合连接,且向后延伸依次穿过外鞘管(6)、大手柄(7),伸入小手柄(11)内固定; 所述外鞘管(6)套装于中管(5)外,后端与大手柄(7)固定连接;在外鞘管(6)的前端设置Pt/Ir金属显影环,在手术过程中显示放送系统在体内到达的确切位置; 所述大手柄(7)内部为前后贯通的长孔,中后段侧壁上伸出一细管与带有三通连接件的延长管(8)连接,液体可通过三通连接件及延长管(8)流入大手柄(7)的内孔从而流入外鞘管(6)与中管(5)之间;大手柄(7)后端设置硅胶密封圈(9)和旋紧螺母(14),通过旋紧螺母(14)挤压密封圈(9),从而压紧中管(5),达到固定中管及密封的作用; The star connecting member (18) is arranged in the middle a recess (24), so that the large end of the five bare stent can be embedded therein, and the pin insertion hole 5 of the pin in the groove to limit, the large vessel stent to achieve bare end restriction release; the tube (5) and the rear end of spring tube crude (20) is connected by a threaded connection, or heat sealing, extending rearwardly and passes through the outer sheath (6), a large handle (7), small projects into handle (11) is fixed; the outer sheath (6) set in the outer tube (5), with the large rear handle (7) is fixedly connected; front end of the outer sheath (6) of the Pt / Ir developing the metal rings, the display exact location of the delivery system arrives in vivo during surgery; the big handle (7) inside an elongated hole penetrating the front and rear, a thin tube extending on the side wall and the posterior segment with the tee fitting the extension tube (8) is connected, the liquid can flow into the large bore of the handle (7) by a tee fitting and the extension pipe (8) into the outer sheath such that (6) and the middle tube (5); big handle ( 7) seals the rear end is provided on silica gel (9) and tighten the nut (14), pressing the sealing ring (9) by screwing the nut (14), thereby compressing the tube (5), to a fixed tube and sealed effect; 所述小手柄(11)的前端通过柄体与中管(5)连接固定,后端通过推送杆(13)与细弹簧管(21)的后端连接固定;小手柄(11)末端管口处设置推送螺母(15)和锁紧螺钉(12),所述推送杆(13)与推送螺母(15)之间采用螺纹配合。 Said small lever (11) is fixed by connecting the front end of the handle body and the tube (5), the rear end by the rear end of the push rod (13) and the thin tube spring (21) is connected and fixed; small handle (11) end of the spout provided at the push nut (15) and locking screw (12), the threaded engagement between the push rod (13) and a push nut (15).
2.根据权利要求1所述的一种大血管支架放送系统,其特征在于,所述定位引导头(2)由医用塑料制成,硬度为20〜50D,外表光滑,用于将系统导入血管内。 A large vessel stent delivery system as recited in claim 1, wherein said head positioning guide (2) made of medical grade plastic, hardness 20~50D, smooth appearance, for introducing the vascular system Inside.
3.根据权利要求1所述的一种大血管支架放送系统,其特征在于,所述销钉座(17)及五角星连接件(18)由高硬度POM、PEBAX医用塑料或不锈钢制成,所述销钉(19)由不锈钢丝或钛镍记忆合金丝制成。 3. According to one of the large vessel stent delivery system of claim 1, wherein said pin seats (17) and a pentagram connecting member (18), made of a high hardness POM PEBAX medical plastic or stainless steel, the said pin (19) is made of stainless steel wire or a nickel titanium memory alloy wire.
4.根据权利要求1所述的一种大血管支架放送系统,其特征在于,所述外鞘管(6)为三层材质挤压结合在一起的管子,外层为PEBAX医用塑料,中间为不锈钢扁丝编织成的网状加强筋,内层为PTFE,内表面光滑,总体壁厚为0.1〜0.3mm。 4. According to one of the large vessel stent delivery system of claim 1, wherein said outer sheath (6) is a three-layer material extruded tubes joined together, the outer layer of PEBAX medical plastic, the middle stainless steel flat wire mesh woven into the reinforcing ribs, the inner layer is PTFE, a smooth inner surface, the overall wall thickness of 0.1~0.3mm.
5.根据权利要求1所述的一种大血管支架放送系统,其特征在于,所述芯管(4)为不锈钢材质,选用医用级304、316或316L不锈钢。 5. According to one large vessel stent delivery system according to claim 1, wherein said core tube (4) of stainless steel, or a selection of medical grade 316L stainless steel 304,316.
6.根据权利要求1所述的一种大血管支架放送系统,其特征在于,所述中管(5)由医用塑料制成,硬度为30〜70D。 A large vessel stent delivery system as recited in claim 1, characterized in that said tube (5) is made of medical plastic, hardness 30~70D.
7.根据权利要求1所述的一种大血管支架放送系统,其特征在于,所述小手柄(11)的材质为POM、PVC或PP。 A large vessel stent delivery system as recited in claim 1, characterized in that said small lever (11) is made of POM, PVC, or PP.
8.根据权利要求2或6所述的一种大血管支架放送系统,其特征在于,所述医用塑料为PEBAX、PE、PU、PEEK 或PP。 8. A member according to claim large vessel stent delivery system of claim 2 or claim 6, wherein the medical plastics PEBAX, PE, PU, ​​PEEK or PP.
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CN201959032U (en) 2010-12-17 2011-09-07 北京有色金属研究总院 Novel large stent delivery system

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