CN103566457B - 具有高度柔性末端的导丝 - Google Patents
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- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/09—Guide wires
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/34—Trocars; Puncturing needles
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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
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- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/09—Guide wires
- A61M25/09016—Guide wires with mandrils
- A61M25/09033—Guide wires with mandrils with fixed mandrils, e.g. mandrils fixed to tip; Tensionable wires
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/09—Guide wires
- A61M2025/09058—Basic structures of guide wires
- A61M2025/09083—Basic structures of guide wires having a coil around a core
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/09—Guide wires
- A61M2025/09191—Guide wires made of twisted wires
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- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
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Abstract
本发明公开了一种医疗装置,该医疗装置由具有重复套环的线圈形成,每个套环形成多边形,并且每个连续的套环相对于其相邻的套环轻微旋转,以形成螺旋构型。在一个优选的实施例中,套环为三角形并且重复的三角形套环线圈可被用作支架递送导管中的导丝。该导丝还可包括设置在所述三角形套环线圈内的刚性芯线,其中所述刚性芯线包括沿远侧方向减小刚度的渐缩的部分。线圈可包括具有不同套环形状(包括圆形)的多个部分,以改变导丝的刚度来满足应用的需要。
Description
技术领域
本发明一般涉及血管介入医疗装置,并且更具体地涉及用于治疗系统或用于递送医疗装置的导丝。
背景技术
基于常规的微创导管的治疗方法,包括用于支架递送的那些治疗方法,通常需要延伸穿过导管中的纵向内腔的1至2米长的导丝,该导丝在近端处为可扭转和可推动的,但在远端处仍为柔软和有弹性的。许多此类导丝由不锈钢等制成,并且被磨成沿导丝提供期望的弯曲性能的渐缩体。对于此类导丝而言有用的是,其从导丝底部为可扭转的,用于操纵远侧末端,该远侧末端通常为弯曲的,以用于引导该远侧末端穿过血管通道。尽管此类导丝尤其是在导丝的近侧区域处需要为可扭转、可推动和有回弹力的,但此类导丝尤其是在导丝的远侧区域处还需要为柔性的。
发明内容
本发明涉及导丝,尤其在末端处具有改善的柔性的导丝,以及制造此类导丝的方法,其中在末端处对导丝的引导至关重要。具体地,本发明的导丝为线圈,当该线圈沿纵向延伸时,其沿横向(或横截面方向)形成多边形套环,并且优选地为可围绕芯构件设置的沿横向的三角形套环。多边形部分可与圆形部分交替,并且这两种类型的部分可以是间断的、连续的、或某一其它组合。芯部分可具有多个邻接的渐缩的区段,以便在装置的纵向部分之上在导丝的刚度方面产生线性变化。作为另外一种选择,芯构件可具有不断递减的渐缩体以产生曲线轮廓,以及在整个渐缩部分之上在刚度方面的线性变化。
对于一些实施例的上述概括并非旨在描述本发明的每个公开实施例或每个具体实施。下文示出的所包括的附图以及详细描述更具体地例证了本发明的实施例。
附图说明
图1是本发明的导丝的第一实施例的正视透视图;
图2是图1的实施例的侧视图;
图3是图1的实施例的轴视图;
图4是多构型导丝和芯构件的侧视图,该侧视图部分地以虚线示出;
图5是具有多个渐缩的部分的芯构件的侧视图;
图6是具有第一衬圈和第二衬圈的替代芯构件的侧视图;
图7是贯穿有三角形套环的芯和导丝的组合的侧视图
图8是具有圆形套环和三角形套环的芯和导丝的组合的侧视图;
图9是沿图8的线9-9截取的剖视图;
图10是沿图8的线10-10截取的剖视图;
图11是具有交替的三角形套环和圆形套环的芯和导丝的组合的侧视图;并且
图12是具有间断的圆形套环和三角形套环的芯和导丝的组合的侧视图。
具体实施方式
用于血管治疗介入的导丝通常在导丝的近侧区域之上需要为可扭转、可推动和有回弹力的,并且在导丝的远侧区域之上为柔性的。尽管渐缩的导丝可提供从近侧的刚度和可扭转性至远侧的柔性,但是此类导丝的近侧刚度的增强可使操纵导丝的医师更好地控制导丝的远侧定位。本发明以独特且新型的方式解决这些问题。图1-3示出了由连续套环形成的导丝线圈10,所述连续套环具有多边形且更具体地具有三角形形状。每个三角形套环12相对于直接相邻的三角形套环轻微地旋转设置,以产生如图1所示的螺旋形图案。旋转位移的量可能因应用而异,从而产生更紧或更松的螺旋构型。
线圈中套环的三角形形状在一个简单的圆形线圈之上产生增强的弯曲模量、弹性模量和拉伸强度。三角形套环提供了如下益处:当该三角形套环被置于圆形的导管内腔内时能够防止线屈曲,而无需将流量限制至圆形横截面导丝的程度其它的多边形套环是可能的,包括正方形、五边形、和六边形。然而,已发现三角形套环在强度和弯曲性能方面能提供最大优势。
可配置线圈的不同顺序和组合以在导丝的纵向部分之上产生刚度方面的线性变化。例如,更柔软的导丝能够被安全且成功地递送进入曲折的或脆弱的血管通道的更深处,例如在大脑中或是心脏血管中这些先前无法对患者进行治疗但现在能够对其进行治疗的位置。本结构使导丝能够在神经手术或心脏手术期间被安全地递送至其被用作其它医疗装置的通道的位置。
图4示出了包括芯线22的导丝20,该芯线通常涂覆有润滑涂层,例如PTFE或其它类似的涂层。芯线22沿近侧至远侧方向包括渐缩体、或径向递减的部件,以在导丝20的远端处产生更具柔性的芯。如脉管系统的应用和状况所要求,渐缩的部分可为连续的、分段的、或它们的组合。在芯线22之上是线圈24,该线圈可包括具有不同横截面形状的多个部分。在图4的导丝中,线圈24沿近侧至远侧方向包括三角形线圈部分26、圆形线圈部分28、另一个三角形线圈部分26、缠绕得更为宽松的圆形线圈30、另一个三角形线圈26、以及端盖32。由于使用了不同的长度以及不同的线圈缠绕特征,使得能够产生更为精确的弯曲和强度轮廓,以适应患者或应用的需要。然而,希望确保位于柔性末端至更具刚性的芯线之间的渐变段长度足够细微,因为过于突然的过度可造成追踪困难。
图5和6示出了具有多个渐缩部分以控制导丝的弯曲的芯线40。芯40的近端42为圆柱形的或具有恒定的半径,并且在其远端处连接到第一适度渐缩的部分44。该渐缩的部分44接合到第二圆柱形部分46,接着是第二渐缩的部分48。第三和最终圆柱形部分50以及渐缩部分52形成完整的导丝40,终止于用于连接端盖32的销54中。在图6中,芯40a包括肋56或延伸部,其有助于在制造期间的轴向定位以及填料线圈的定心。这些肋56也充当穿过患者的脉管系统递送的支架和其它装置的定位标记以及附加的推动/牵拉支撑件。芯可采用许多其它形式并具有在数量和程度上均变化的连续的、分段的和交替的渐缩部分。
图7示出了本发明的导丝60的另一个例子,包括具有近侧圆柱形部分62的芯61、包括抛物线近侧顶盖66的渐缩的配件64、以及端盖70。在近侧顶盖66与端盖70之间是三角形线圈68,该三角形线圈将芯线61的远端捕集在每个三角形套环内。图8的导丝60a与图7的导丝60类似,但除了三角形套环部分68还包括圆形套环部分67。如图9和10所示,芯线61沿导丝60a的长度被捕集在圆形套环67和三角形套环68中。在图11中,导丝60b具有夹置圆形套环部分67的两个三角形套环部分68。在图12中,导丝60c在线圈中具有由间隙73隔开的圆形套环部分67和三角形套环部分。
穿过变窄的或狭窄的消融区域的能力对导丝功能而言是极其重要的。无能力穿过至目标区域会使任何成功的进程出轨。本发明结合具有更具柔性的末端的更具刚性的芯主体,解决了该挑战。更为柔软的末端导丝可成功并安全地进一步被递送到大脑或心脏脉管系统,并且可允许对否则将没有选择的一些患者进行治疗。由于末端的柔软特性,本发明降低了在外科手术期间导丝末端刺穿血管的风险。三角形线圈也通过如下来降低递送力:减少与进入装置内径的接触,同时当导丝处于适当位置时增加穿过导管的任何液体流动。也就是说,Δ或三角形轮廓产生在导丝处于适当位置时可允许流体流过导管的间隙。
Claims (5)
1.一种医疗装置,包括由连续的多边形形成的线圈,每个多边形旋转地从其相邻的多边形移位以形成螺旋构型;
其中所述多边形为三角形;
其中所述医疗装置为导丝;
其中在所述线圈内的是延伸穿过其中的芯线;
其中所述芯线具有介于近端与远端之间的至少一个渐缩部分;以及
其中所述线圈除了三角形套环还包括圆形套环部分。
2.根据权利要求1所述的医疗装置,其中所述芯线在近端处比在远端处更具刚性。
3.根据权利要求1所述的医疗装置,其中所述芯线包括第一间隔开的肋和第二间隔开的肋。
4.根据权利要求1所述的医疗装置,其中所述圆形套环部分被夹置在两个三角形套环部分之间。
5.根据权利要求1所述的医疗装置,其中在所述线圈中所述圆形套环部分与所述三角形套环由间隙间隔开。
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US13/554981 | 2012-07-20 | ||
US13/554,981 US8986224B2 (en) | 2012-07-20 | 2012-07-20 | Guidewire with highly flexible tip |
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CN103566457B true CN103566457B (zh) | 2018-03-30 |
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EP (1) | EP2687255B1 (zh) |
JP (1) | JP6355899B2 (zh) |
KR (1) | KR102161117B1 (zh) |
CN (1) | CN103566457B (zh) |
AU (1) | AU2013207563B2 (zh) |
BR (1) | BR102013018528A8 (zh) |
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ES (1) | ES2542133T3 (zh) |
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KR20230098609A (ko) * | 2020-10-28 | 2023-07-04 | 레스 앙트르프리즈 나노스텐트 아이엔씨. | 카테터의 밀기 능력을 증가시키는 카테터 액세서리 |
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CN114247035A (zh) * | 2021-12-08 | 2022-03-29 | 杭州拓脉医疗科技有限公司 | 医用微导丝 |
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- 2013-07-19 ES ES13177317.8T patent/ES2542133T3/es active Active
- 2013-07-19 KR KR1020130085556A patent/KR102161117B1/ko active IP Right Grant
- 2013-07-19 BR BR102013018528A patent/BR102013018528A8/pt not_active Application Discontinuation
- 2013-07-19 EP EP20130177317 patent/EP2687255B1/en not_active Not-in-force
- 2013-07-19 CA CA2821543A patent/CA2821543A1/en not_active Abandoned
- 2013-07-19 CN CN201310305850.8A patent/CN103566457B/zh not_active Expired - Fee Related
- 2013-07-19 JP JP2013150247A patent/JP6355899B2/ja not_active Expired - Fee Related
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Also Published As
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CN103566457A (zh) | 2014-02-12 |
US8986224B2 (en) | 2015-03-24 |
US20140024968A1 (en) | 2014-01-23 |
KR20140011994A (ko) | 2014-01-29 |
JP6355899B2 (ja) | 2018-07-11 |
EP2687255B1 (en) | 2015-05-06 |
JP2014018673A (ja) | 2014-02-03 |
ES2542133T3 (es) | 2015-07-31 |
KR102161117B1 (ko) | 2020-09-29 |
BR102013018528A8 (pt) | 2018-05-22 |
AU2013207563A1 (en) | 2014-02-06 |
US20150174378A1 (en) | 2015-06-25 |
AU2013207563B2 (en) | 2017-11-16 |
EP2687255A1 (en) | 2014-01-22 |
BR102013018528A2 (pt) | 2015-08-18 |
CA2821543A1 (en) | 2014-01-20 |
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