JP2018166922A - Medical long body - Google Patents

Medical long body Download PDF

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JP2018166922A
JP2018166922A JP2017067904A JP2017067904A JP2018166922A JP 2018166922 A JP2018166922 A JP 2018166922A JP 2017067904 A JP2017067904 A JP 2017067904A JP 2017067904 A JP2017067904 A JP 2017067904A JP 2018166922 A JP2018166922 A JP 2018166922A
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Prior art keywords
expansion
shaft
linear
tube
state
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JP6769905B2 (en
Inventor
山口 裕史
Yasushi Yamaguchi
裕史 山口
豊 田野
Yutaka Tano
豊 田野
啓二 福田
Keiji Fukuda
啓二 福田
哲矢 西村
Tetsuya Nishimura
哲矢 西村
真史 上野
Shinji Ueno
真史 上野
洋輝 上内
Hiroki Kamiuchi
洋輝 上内
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テルモ株式会社
Terumo Corp
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32Surgical cutting instruments
    • A61B17/3205Excision instruments
    • A61B17/3207Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
    • A61B17/320725Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions with radially expandable cutting or abrading elements
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22051Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation
    • A61B2017/22061Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation for spreading elements apart

Abstract

To provide a medical long body improved in expandability of a narrow section and passability during delivery of the lumen of the living body.SOLUTION: An expansion member 130 included in a medical long body 10 includes a constricted state in which a plurality of blade parts 140 are arranged in a shaft 100 so as to be wound, and an expanded state expanding in the radial direction of the shaft. A linear member 150 has a deformation area 150A forming a protrusion in a natural state in a position in which the linear member is overlapped on the expansion member in the circumferential direction of the expansion member. The deformation area is arranged between the adjacent blade parts of the expansion member while being inhibited from forming a protrusion 155a in a constricted state of the expansion member, and forms a protrusion at an outer surface side of the expansion member due to that the expansion member is expanded in the radial direction in an expanded state of the expansion member.SELECTED DRAWING: Figure 3

Description

本発明は、生体管腔で拡張可能な拡張部材を備えた医療用長尺体に関する。   The present invention relates to a medical elongated body including an expansion member that can be expanded in a living body lumen.
血管等の生体管腔に形成された狭窄部等の病変部位を拡張する医療装置として、いわゆるバルーンカテーテルと称される医療用長尺体が知られている。また、バルーンカテーテルの一つとして、スコアリング機能が付加されたスコアリングバルーンカテーテル(カッティングバルーンカテーテル)が知られている。   As a medical device for expanding a lesion site such as a stenosis formed in a living body lumen such as a blood vessel, a medical long body called a so-called balloon catheter is known. As one of balloon catheters, a scoring balloon catheter (cutting balloon catheter) to which a scoring function is added is known.
スコアリングバルーンカテーテルは、バルーン(拡張部材)の外表面に取り付けられたブレードを有している。一般的に、ブレードは、バルーンよりも剛性の高い樹脂や金属で構成されている(例えば、特許文献1を参照)。   The scoring balloon catheter has a blade attached to the outer surface of the balloon (expansion member). In general, the blade is made of a resin or metal having rigidity higher than that of the balloon (see, for example, Patent Document 1).
スコアリングバルーンカテーテルは、狭窄部を拡張させる処置に際し、バルーンに取り付けられたブレードを狭窄部に喰い込ませることにより、狭窄部に切れ目(亀裂)を入れながら、狭窄部を拡張できる。このため、スコアリングバルーンカテーテルは、高度石灰化病変(石灰化により硬化した病変部)の拡張に対して、特に高い治療効果を奏する。   The scoring balloon catheter can expand the stenosis part while making a cut (crack) in the stenosis part by causing the blade attached to the balloon to bite into the stenosis part in the treatment of expanding the stenosis part. For this reason, the scoring balloon catheter has a particularly high therapeutic effect on the expansion of highly calcified lesions (lesions hardened by calcification).
特表2008−504059号Special table 2008-504059
しかしながら、特許文献1に記載されたスコアリングバルーンカテーテルは、バルーンとは別部材で構成された比較的剛性の高いブレードがバルーンの外表面に凸状をなすように常設されている。このため、上記のスコアリングバルーンカテーテルは、生体管腔での送達時(バルーンの収縮時)におけるバルーンの外径が大きくなってしまい、バルーンの通過性(送達性)が低下するという課題がある。   However, the scoring balloon catheter described in Patent Document 1 is always installed such that a relatively rigid blade made of a member different from the balloon has a convex shape on the outer surface of the balloon. For this reason, the above scoring balloon catheter has a problem that the outer diameter of the balloon becomes large during delivery in the living body lumen (when the balloon is deflated), and the passage of the balloon (delivery property) decreases. .
本発明は、上記課題を鑑みてなされたものであり、狭窄部の拡張性および生体管腔送達時の通過性の向上が図られた医療用長尺体を提供することを目的とする。   This invention is made | formed in view of the said subject, and it aims at providing the medical elongate body by which the improvement of the expansibility of a stenosis part and the permeability | transmittance at the time of living body lumen delivery was aimed at.
本発明に係る医療用長尺体は、シャフトと、前記シャフトの先端部に固定された拡張部材と、前記シャフトの先端側または前記拡張部材の先端側に固定され、少なくとも一部が前記拡張部材の外表面側に配置された線状部材と、を備え、前記拡張部材は、前記シャフトに複数の羽根部を巻きつけるように配置された収縮状態と、前記シャフトの放射方向に拡張した拡張状態と、を有し、前記線状部材は、前記拡張部材の周方向において前記拡張部材と重なる位置に、自然状態で凸部を形成する変形領域を有し、前記変形領域は、前記拡張部材の収縮状態において、前記凸部を形成することを阻害されつつ、前記拡張部材の隣り合う羽根部の間に配置され、前記拡張部材の拡張状態において、前記拡張部材が放射方向に拡張することにより、前記拡張部材の外表面側で前記凸部を形成する。   A medical elongated body according to the present invention includes a shaft, an expansion member fixed to the distal end portion of the shaft, and is fixed to the distal end side of the shaft or the distal end side of the expansion member, and at least a part thereof is the expansion member. A linear member disposed on the outer surface side of the shaft, wherein the expansion member is in a contracted state in which a plurality of blade portions are wound around the shaft, and in an expanded state in which the shaft is expanded in the radial direction. The linear member has a deformation region that forms a convex portion in a natural state at a position overlapping with the expansion member in a circumferential direction of the expansion member, and the deformation region is a region of the expansion member. In the contracted state, while being inhibited from forming the convex portion, it is disposed between adjacent blade portions of the expansion member, and in the expanded state of the expansion member, the expansion member expands in the radial direction, Previous Forming the protrusions on the outer surface side of the extension member.
本発明に係る医療用長尺体は、狭窄部を拡張する際、線状部材が拡張部材の外表面側で凸部を形成するため、狭窄部に対する拡張部材の拡張力が向上する。また、本発明に係る医療用長尺体は、狭窄部まで拡張部材を送達する際、線状部材が拡張部材の外表面側で凸部を形成しないようにその変形が阻害されるため、拡張部材の外径が大きくなるのを防止でき、生体管腔での通過性が向上する。   In the medical elongated body according to the present invention, when the stenosis portion is expanded, the linear member forms a convex portion on the outer surface side of the expansion member, so that the expansion force of the expansion member with respect to the stenosis portion is improved. In addition, when the medical elongated body according to the present invention delivers the expansion member to the narrowed portion, the linear member is inhibited from deforming so as not to form a convex portion on the outer surface side of the expansion member. An increase in the outer diameter of the member can be prevented, and the passage through the living body lumen is improved.
本発明の実施形態に係る医療用長尺体を示す図である。It is a figure which shows the medical elongate body which concerns on embodiment of this invention. 図2(A)は、収縮した状態の拡張部材の軸方向の断面を示す図であり、図2(B)は、図2(A)に示す矢印2B−2B線に沿う断面図(軸直交断面図)である。FIG. 2A is a view showing a cross section in the axial direction of the expanded member in a contracted state, and FIG. 2B is a cross-sectional view along the line 2B-2B shown in FIG. FIG. 図3(A)は、拡張した状態の拡張部材の軸方向の断面を示す図であり、図3(B)は、図3(A)に示す矢印3B−3B線に沿う断面図(軸直交断面図)である。3A is a view showing a cross section in the axial direction of the expanded member in an expanded state, and FIG. 3B is a cross-sectional view along the line 3B-3B shown in FIG. FIG. 変形例1に係る医療用長尺体を示す図であり、図4(A)は、収縮した状態の拡張部材の軸直交断面図であり、図4(B)は、拡張した状態の拡張部材の軸直交断面図である。It is a figure which shows the medical elongate body which concerns on the modification 1, FIG. 4 (A) is an axial orthogonal sectional view of the expansion member of the contracted state, and FIG. 4 (B) is the expansion member of the expanded state. FIG. 変形例1に係る医療用長尺体を示す図であり、拡張した状態の拡張部材の軸方向の断面を示す図である。It is a figure which shows the medical elongate body which concerns on the modification 1, and is a figure which shows the cross section of the axial direction of the expansion member of the expanded state. 変形例2に係る医療用長尺体を示す図であり、図6(A)は、収縮した状態の拡張部材の軸直交断面図であり、図6(B)は、拡張した状態の拡張部材の軸直交断面図である。It is a figure which shows the medical elongate body which concerns on the modification 2, FIG. 6 (A) is an axial orthogonal sectional view of the expansion member of the contracted state, and FIG. 6 (B) is the expansion member of the expanded state. FIG. 変形例2に係る医療用長尺体を示す図であり、拡張した状態の拡張部材の軸方向の断面を示す図である。It is a figure which shows the medical elongate body which concerns on the modification 2, and is a figure which shows the cross section of the axial direction of the expansion member of the expanded state. 変形例3に係る医療用長尺体を示す図である。It is a figure which shows the medical elongate body which concerns on the modification 3. FIG.
以下、各図面を参照して、本発明の実施形態を説明する。なお、図面の寸法比率は、説明の都合上誇張されており、実際の比率とは異なる場合がある。   Embodiments of the present invention will be described below with reference to the drawings. In addition, the dimension ratio of drawing is exaggerated on account of description, and may differ from an actual ratio.
図1は、シャフト100の基端側の拡大断面図とともに医療用長尺体10の全体構成を簡略して示す図であり、図2(A)は収縮した状態の拡張部材130の軸方向の断面図、図2(B)は図2(A)に示す矢印2B−2B線に沿う軸直交断面図、図3(A)は拡張した状態の拡張部材130の軸方向の断面図、図3(B)は図3(A)に示す矢印3B−3B線に沿う軸直交断面図である。   FIG. 1 is a diagram showing the overall configuration of the medical elongated body 10 together with an enlarged cross-sectional view of the proximal end side of the shaft 100, and FIG. 2 (A) is an axial view of the expanded member 130 in a contracted state. 2B is an axial cross-sectional view taken along the line 2B-2B shown in FIG. 2A, FIG. 3A is an axial cross-sectional view of the expanded member 130 in an expanded state, and FIG. (B) is an axial orthogonal cross-sectional view along the arrow 3B-3B line shown in FIG.
図1に示すように、本実施形態に係る医療用長尺体10は、シャフト100の先端側に配置された拡張部材(バルーン)130を生体管腔に形成された狭窄部等の病変部位において拡張させることにより、病変部位を押し広げて治療する医療装置である。   As shown in FIG. 1, the medical elongated body 10 according to the present embodiment has an expansion member (balloon) 130 disposed on the distal end side of the shaft 100 at a lesion site such as a stenosis formed in a body lumen. It is a medical device that expands and treats a lesion site by expanding.
医療用長尺体10は、冠動脈の狭窄部を広げるために使用されるPTCA治療用バルーンカテーテルとして構成している。ただし、医療用長尺体10は、例えば、他の血管、胆管、気管、食道、その他消化管、尿道、耳鼻内腔、その他の臓器等の生体器官内に形成された狭窄部等の病変部位の治療を目的としたバルーンカテーテルとして構成することもできる。   The medical elongate body 10 is configured as a PTCA treatment balloon catheter used to widen a stenosis of a coronary artery. However, the medical elongate body 10 is, for example, a lesion site such as a stenosis portion formed in a living organ such as another blood vessel, bile duct, trachea, esophagus, other digestive tract, urethra, ear nose lumen, and other organs. It can also be configured as a balloon catheter for the purpose of treatment.
以下、図1〜図3を参照して、本実施形態に係る医療用長尺体10について説明する。   Hereinafter, with reference to FIGS. 1-3, the medical elongate body 10 which concerns on this embodiment is demonstrated.
図1に示すように、医療用長尺体10は、長尺状のシャフト100と、シャフト100の先端側に配置された拡張部材130と、拡張部材130およびシャフト100に配置された線状部材150と、シャフト100の基端側に配置された耐キンクプロテクタ180と、シャフト100の基端側かつ耐キンクプロテクタ180の基端側に配置されたハブ190と、を有している。   As shown in FIG. 1, the medical elongated body 10 includes a long shaft 100, an expansion member 130 disposed on the distal end side of the shaft 100, and the linear member disposed on the expansion member 130 and the shaft 100. 150, a kink protector 180 disposed on the proximal end side of the shaft 100, and a hub 190 disposed on the proximal end side of the shaft 100 and on the proximal end side of the kink resistant protector 180.
実施形態の説明において、拡張部材130を配置した側を医療用長尺体10の先端側とし、ハブ190を配置した側を医療用長尺体10の基端側とし、シャフト100が延伸する方向を軸方向とする。また、実施形態の説明において、先端部とは、先端(最先端)およびその周辺を含む一定の範囲を意味し、基端部とは、基端(最基端)およびその周辺を含む一定の範囲を意味する。   In the description of the embodiment, the side on which the expansion member 130 is disposed is the distal end side of the medical elongated body 10, the side on which the hub 190 is disposed is the proximal end side of the medical elongated body 10, and the shaft 100 extends. Is the axial direction. Further, in the description of the embodiments, the distal end portion means a certain range including the distal end (the most distal end) and the periphery thereof, and the proximal end portion means a certain range including the proximal end (the most proximal end) and the periphery thereof. Means range.
図1に示すように、医療用長尺体10は、シャフト100の先端側寄りにガイドワイヤ200が出入り可能な基端開口部(ガイドワイヤポート)105が形成された、いわゆるラピッドエクスチェンジ型のカテーテルとして構成している。   As shown in FIG. 1, a medical elongate body 10 is a so-called rapid exchange type catheter in which a proximal end opening (guide wire port) 105 through which a guide wire 200 can enter and exit is formed near the distal end side of a shaft 100. It is configured as.
図2(A)に示すように、シャフト100は、内腔(拡張ルーメン)115を備える外管シャフト110と、ガイドワイヤ200が挿通される内腔(ガイドワイヤルーメン)125を備える内管シャフト120と、を有している。   As shown in FIG. 2A, the shaft 100 includes an outer tube shaft 110 having a lumen (expansion lumen) 115 and an inner tube shaft 120 having a lumen (guide wire lumen) 125 through which the guide wire 200 is inserted. And have.
内管シャフト120は、軸方向に延在する管状部材(チューブ部材)で形成している。図1に示すシャフト100の基端開口部105は、内管シャフト120の基端開口部により形成している。   The inner tube shaft 120 is formed of a tubular member (tube member) extending in the axial direction. The base end opening 105 of the shaft 100 shown in FIG. 1 is formed by the base end opening of the inner tube shaft 120.
外管シャフト110は、例えば、シャフト100の基端開口部105付近において内管シャフト120と一体的に接続(融着)される先端側シャフトおよび基端側シャフト(各シャフトの図示は省略する)で形成できる。   The outer tube shaft 110 includes, for example, a distal end shaft and a proximal end shaft that are integrally connected (fused) with the inner tube shaft 120 in the vicinity of the proximal end opening 105 of the shaft 100 (illustration of each shaft is omitted). Can be formed.
図2(A)に示すように、内管シャフト120の先端側は、外管シャフト110の内腔115に配置している。内管シャフト120の先端側の一定の範囲は、外管シャフト110の先端側へ突出するように配置している。   As shown in FIG. 2A, the distal end side of the inner tube shaft 120 is disposed in the lumen 115 of the outer tube shaft 110. A certain range on the distal end side of the inner tube shaft 120 is disposed so as to protrude toward the distal end side of the outer tube shaft 110.
内管シャフト120の先端側には先端部材170を配置している。先端部材170は、医療用長尺体10の先端が生体管腔(血管の内壁等)に接触した際に、生体器官に損傷が生じることを防止する。先端部材170は、例えば、柔軟な樹脂材料で形成できる。ただし、先端部材170の材質は、内管シャフト120に対して固定が可能なものであれば特に限定されない。   A distal end member 170 is disposed on the distal end side of the inner tube shaft 120. The distal end member 170 prevents the living organ from being damaged when the distal end of the medical elongated body 10 contacts the living body lumen (such as the inner wall of the blood vessel). The tip member 170 can be formed of a flexible resin material, for example. However, the material of the tip member 170 is not particularly limited as long as it can be fixed to the inner tube shaft 120.
図2(A)に示すように、拡張部材130は、内管シャフト120の放射方向に拡張する拡張本体部131と、拡張本体部131の先端側に配置され、内管シャフト120の先端122と固定される先端側固定部132と、拡張本体部131の基端側に配置され、外管シャフト110の先端112と固定される基端側固定部133と、を有している。   As shown in FIG. 2 (A), the expansion member 130 is disposed on the distal end side of the expansion main body 131, the expansion main body 131 expanding in the radial direction of the inner pipe shaft 120, and the front end 122 of the inner pipe shaft 120. The distal end side fixing portion 132 to be fixed and the proximal end side fixing portion 133 that is disposed on the proximal end side of the expansion main body portion 131 and is fixed to the distal end 112 of the outer tube shaft 110 are provided.
また、拡張部材130は、拡張部材130の先端側固定部132と拡張部材130の拡張本体部131との間に形成された先端側テーパー部134と、拡張部材130の基端側固定部133と拡張部材130の拡張本体部131との間に形成された基端側テーパー部135と、を有している。   Further, the expansion member 130 includes a distal end side tapered portion 134 formed between the distal end side fixing portion 132 of the expansion member 130 and the expansion main body portion 131 of the expansion member 130, and a proximal end fixing portion 133 of the expansion member 130. A proximal-side tapered portion 135 formed between the expansion member 130 and the expansion main body 131.
拡張部材130は、内管シャフト120の外周面との間に、外管シャフト110の内腔115と連通する拡張空間137を形成している。   The expansion member 130 forms an expansion space 137 communicating with the inner cavity 115 of the outer tube shaft 110 between the outer circumferential surface of the inner tube shaft 120.
図2(B)に示すように、拡張部材130は、拡張空間137に流体が流入していない状態において、内管シャフト120に複数の羽根部140を巻きつけるように配置された収縮状態を形成する。   As shown in FIG. 2B, the expansion member 130 forms a contracted state in which a plurality of blade portions 140 are wound around the inner tube shaft 120 in a state where no fluid flows into the expansion space 137. To do.
拡張部材130の羽根部140は、拡張部材130の外表面同士を内管シャフト120の周方向に重ね合わせるように配置して形成される。本実施形態では、図2(B)に示すように、医療用長尺体10は、内管シャフト120の周方向の異なる位置に3つの羽根部140が形成されるように拡張部材130が折り畳まれている。   The blade portion 140 of the expansion member 130 is formed by arranging the outer surfaces of the expansion member 130 so as to overlap each other in the circumferential direction of the inner tube shaft 120. In this embodiment, as shown in FIG. 2B, the medical elongated body 10 has the expansion member 130 folded so that the three blade portions 140 are formed at different positions in the circumferential direction of the inner tube shaft 120. It is.
図2(B)に示すように、拡張部材130の羽根部140は、拡張部材130の外表面同士が向かい合う位置に所定の空間部141を形成する。この空間部141には、線状部材150および後述するチューブ部材160を配置している。   As shown in FIG. 2B, the blade portion 140 of the expansion member 130 forms a predetermined space portion 141 at a position where the outer surfaces of the expansion member 130 face each other. In the space 141, a linear member 150 and a tube member 160 described later are disposed.
図2(B)に示すように、拡張部材130は、拡張部材130の収縮状態において、隣り合う羽根部140同士を固定する仮固定部145を有している。   As shown in FIG. 2B, the expansion member 130 has a temporary fixing portion 145 that fixes adjacent blade portions 140 in a contracted state of the expansion member 130.
仮固定部145は、例えば、拡張部材130の羽根部140の一部を接着や融着することで形成できる。   The temporary fixing part 145 can be formed by, for example, bonding or fusing part of the blade part 140 of the expansion member 130.
仮固定部145による隣り合う羽根部140同士の固定は、拡張部材130が収縮した状態において、維持される。線状部材150およびチューブ部材160は、拡張部材130が収縮した状態では、拡張部材130の羽根部140により形成された空間部141内に配置される。   The fixing of the adjacent blade portions 140 by the temporary fixing portion 145 is maintained in a state where the expansion member 130 is contracted. The linear member 150 and the tube member 160 are disposed in the space portion 141 formed by the blade portion 140 of the expansion member 130 when the expansion member 130 is contracted.
図3(B)に示すように、仮固定部145による隣り合う羽根部140同士の固定は、拡張部材130の拡張状態において、解除される。後述するように、隣り合う羽根部140同士の固定が解除されると、線状部材150およびチューブ部材160が拡張部材130の外表面側に配置され、線状部材150により凸部155aが形成される。   As shown in FIG. 3B, the fixing of the adjacent blade portions 140 by the temporary fixing portion 145 is released in the expanded state of the expansion member 130. As will be described later, when the fixing of the adjacent blade portions 140 is released, the linear member 150 and the tube member 160 are arranged on the outer surface side of the expansion member 130, and the convex portion 155a is formed by the linear member 150. The
なお、羽根部140に仮固定部145を形成する位置、一つの羽根部140に仮固定部145を形成する数等は、空間部141に線状部材150およびチューブ部材160を配置可能な限り、特に限定されない。また、空間部141において線状部材150およびチューブ部材160を配置する箇所は、拡張部材130が拡張した際、線状部材150が凸部155aを形成可能な限り、特に限定されない。   In addition, as long as the linear member 150 and the tube member 160 can be arranged in the space portion 141, the position where the temporary fixing portion 145 is formed in the blade portion 140, the number of temporary fixing portions 145 formed in one blade portion 140, and the like can be arranged. There is no particular limitation. Further, the position where the linear member 150 and the tube member 160 are arranged in the space 141 is not particularly limited as long as the linear member 150 can form the convex portion 155a when the expansion member 130 is expanded.
図3(B)に示すように、拡張部材130は、拡張空間137内に流体が流入すると、拡張部材130の軸方向と交差する放射方向へ拡張する。拡張部材130は、拡張部材130の羽根部140を放射方向へ広げるように拡張することにより、図3(B)に示すように略円形の断面形状となる。   As shown in FIG. 3B, when the fluid flows into the expansion space 137, the expansion member 130 expands in a radial direction that intersects the axial direction of the expansion member 130. The expansion member 130 has a substantially circular cross-sectional shape as shown in FIG. 3B by expanding the blade portion 140 of the expansion member 130 so as to expand in the radial direction.
なお、本実施形態において拡張部材130が拡張した状態とは、拡張部材130が推奨拡張圧で拡張した状態を意味する。   In the present embodiment, the state in which the expansion member 130 is expanded means a state in which the expansion member 130 is expanded with the recommended expansion pressure.
図2(A)に示すように、内管シャフト120は、拡張部材130の先端側テーパー部134と拡張部材130の拡張本体部131との間の境界部を示す造影マーカー129aと、拡張部材130の基端側テーパー部135と拡張本体部131との間の境界部を示す造影マーカー129bと、を有している。各造影マーカー129a、129bは、例えば、白金、金、銀、イリジウム、チタン、タングステン等の金属、またはこれらの合金等により形成できる。なお、造影マーカーは、拡張部材130の拡張本体部131の軸方向の略中心位置を示す位置に配置してもよい。   As shown in FIG. 2A, the inner tube shaft 120 includes a contrast marker 129 a indicating a boundary portion between the distal end side tapered portion 134 of the expansion member 130 and the expansion main body portion 131 of the expansion member 130, and the expansion member 130. A contrast marker 129b indicating a boundary portion between the base end side taper portion 135 and the extended main body portion 131. Each contrast marker 129a, 129b can be formed of, for example, a metal such as platinum, gold, silver, iridium, titanium, tungsten, or an alloy thereof. Note that the contrast marker may be disposed at a position indicating a substantially central position in the axial direction of the expansion main body 131 of the expansion member 130.
図1に示すように、ハブ190は、流体(例えば、造影剤や生理食塩水)を供給するためのインデフレーター等の供給装置(図示省略)と液密・気密に接続可能なポート191を有している。ハブ190のポート191は、例えば、チューブ等が接続・分離可能に構成された公知のルアーテーパー等によって構成できる。   As shown in FIG. 1, the hub 190 has a port 191 that can be connected in a liquid-tight and air-tight manner to a supply device (not shown) such as an indeflator for supplying a fluid (for example, a contrast medium or physiological saline). doing. The port 191 of the hub 190 can be configured by, for example, a known luer taper configured such that a tube or the like can be connected / separated.
耐キンクプロテクタ180は、シャフト100とハブ190の連結部付近に配置している。耐キンクプロテクタ180は、シャフト100の基端部付近でシャフト100にキンク等が発生するのを防止する。   The kink protector 180 is disposed in the vicinity of the connecting portion between the shaft 100 and the hub 190. The kink protector 180 prevents kinks and the like from being generated on the shaft 100 near the base end of the shaft 100.
次に、線状部材150およびチューブ部材160について詳述する。   Next, the linear member 150 and the tube member 160 will be described in detail.
図2(A)および図3(A)に示すように、線状部材150は、拡張部材130の周方向において拡張部材130と重なる位置に、自然状態で凸部155aを形成する変形領域150Aを有している。   As shown in FIG. 2A and FIG. 3A, the linear member 150 has a deformation region 150A that forms a convex portion 155a in a natural state at a position overlapping the expansion member 130 in the circumferential direction of the expansion member 130. Have.
図2(B)に示すように、線状部材150の変形領域150Aは、拡張部材130の収縮状態において、凸部155aを形成することを阻害されつつ、拡張部材130の隣り合う羽根部140の間の空間部141に配置されている。   As shown in FIG. 2 (B), the deformation region 150A of the linear member 150 is prevented from forming the convex portion 155a in the contracted state of the expansion member 130, while the adjacent blade portion 140 of the expansion member 130 is blocked. It arrange | positions in the space part 141 between.
図3(B)に示すように、線状部材150の変形領域150Aは、拡張部材130の拡張状態において、拡張部材130が放射方向に拡張することにより、拡張部材130の外表面側で凸部155aを形成する。   As shown in FIG. 3B, the deformation region 150A of the linear member 150 has a convex portion on the outer surface side of the expansion member 130 when the expansion member 130 expands in the radial direction in the expanded state of the expansion member 130. 155a is formed.
なお、本実施形態においては、図2(B)および図3(B)に示すように、線状部材150およびチューブ部材160は、拡張部材130の周方向に3つ配置しているが、図1、図2(A)、図3(A)においては、1つの線状部材150および1つのチューブ部材160のみを図示し、他の線状部材150およびチューブ部材160の図示は省略している。   In this embodiment, as shown in FIGS. 2B and 3B, three linear members 150 and three tube members 160 are arranged in the circumferential direction of the expansion member 130. 1, FIG. 2 (A) and FIG. 3 (A), only one linear member 150 and one tube member 160 are illustrated, and the other linear members 150 and the tube member 160 are not shown. .
図3(A)に示すように、線状部材150の変形領域150Aは、自然状態で複数の凸部155aを形成するコイル部155で構成している。また、図2(A)および図2(B)に示すように、線状部材150は、拡張部材130の収縮状態において、コイル部155が軸方向に伸長された状態で、拡張部材130の隣り合う羽根部140の間に配置される。   As shown in FIG. 3 (A), the deformation region 150A of the linear member 150 includes a coil portion 155 that forms a plurality of convex portions 155a in a natural state. 2A and 2B, the linear member 150 is adjacent to the expansion member 130 in a state where the coil portion 155 is extended in the axial direction when the expansion member 130 is contracted. It arrange | positions between the blade | wing parts 140 which fit.
上記のコイル部とは、自然状態(外力が付加されていない状態)で拡張部材130の軸方向の一定の範囲に亘って所定の形状の凸部が連続的に形成される形状又は構造を意味する。   The coil portion means a shape or structure in which convex portions having a predetermined shape are continuously formed over a certain range in the axial direction of the expansion member 130 in a natural state (a state where no external force is applied). To do.
図3(A)および図3(B)に示すように、線状部材150は、拡張部材130の拡張状態において、コイル部155を形成する。本実施形態では、線状部材150は、軸方向に螺旋状に延在するコイル部155を形成することにより、拡張部材130の外表面側に複数の凸部155aを形成する。線状部材150は、自然状態において上記のような螺旋状のコイル部155を形成するように変形領域150Aに予め形状付けがなされている。また、線状部材150の変形領域150Aの基端側には、拡張部材130が拡張変形した際にも凸部155aを形成するように変形しない延在領域150Bが形成されている。換言すると、延在領域150Bは、線状部材150において凸部155aを形成するような形状付けが施されていない領域である。   As shown in FIGS. 3A and 3B, the linear member 150 forms a coil portion 155 when the expansion member 130 is in the expanded state. In the present embodiment, the linear member 150 forms a plurality of convex portions 155 a on the outer surface side of the expansion member 130 by forming a coil portion 155 that spirally extends in the axial direction. The linear member 150 is shaped in advance in the deformation region 150A so as to form the spiral coil portion 155 as described above in a natural state. Further, an extension region 150B that is not deformed so as to form the convex portion 155a when the expansion member 130 is expanded and deformed is formed on the proximal end side of the deformation region 150A of the linear member 150. In other words, the extended region 150B is a region where the linear member 150 is not shaped so as to form the convex portion 155a.
図3(A)および図3(B)に示すように、本実施形態では、線状部材150の変形領域150Aが形成するコイル部155は、拡張部材130が拡張した状態において、チューブ部材160の内周面に沿って円形形状に巻回して、拡張部材130の外表面側で凸部155aを形成する。なお、コイル部155が形成する凸部155aの形状は、円形形状に限定されず、例えば、後述する変形例で説明する楕円形状や三角形状、その他の形状(矩形形状)等であってもよい。   As shown in FIGS. 3A and 3B, in this embodiment, the coil portion 155 formed by the deformation region 150 </ b> A of the linear member 150 has the tube member 160 in the expanded state. A convex portion 155 a is formed on the outer surface side of the expansion member 130 by winding in a circular shape along the inner peripheral surface. Note that the shape of the convex portion 155a formed by the coil portion 155 is not limited to a circular shape, and may be, for example, an elliptical shape, a triangular shape, or other shapes (rectangular shapes) described in a modification example described later. .
図1に示すように、医療用長尺体10は、拡張部材130の外表面およびシャフト100の外表面に配置されたチューブ部材160を有している。図2(A)に示すように、線状部材150は、チューブ部材160の内腔165に配置している。   As shown in FIG. 1, the medical long body 10 has a tube member 160 disposed on the outer surface of the expansion member 130 and the outer surface of the shaft 100. As shown in FIG. 2A, the linear member 150 is disposed in the lumen 165 of the tube member 160.
図2(A)および図2(B)に示すように、線状部材150は、拡張部材130が収縮状態のとき、チューブ部材160の内腔165に収容された状態で変形領域150Aに凸部155aが形成されないように、その変形が抑制される。また、拡張部材130が収縮した状態において、線状部材150の変形領域150Aおよび延在領域150Bは、自然状態でコイル部155を形成する変形領域150Aが軸方向に引き伸ばされた状態で拘束されるため、撓んだ状態で軸方向に延在する。   As shown in FIGS. 2A and 2B, when the expansion member 130 is in the contracted state, the linear member 150 has a convex portion in the deformation region 150A while being accommodated in the lumen 165 of the tube member 160. The deformation is suppressed so that 155a is not formed. Further, in a state where the expansion member 130 is contracted, the deformation region 150A and the extension region 150B of the linear member 150 are restrained in a state where the deformation region 150A that forms the coil portion 155 in the natural state is stretched in the axial direction. Therefore, it extends in the axial direction in a bent state.
なお、延在領域150Bの基端側には、例えば、線状部材150の変形領域150Aが凸部155aを形成する際、変形領域150Aの変形に伴って軸方向に伸長する伸長領域を設けてもよい。伸長領域は、線状部材150の変形領域150Aに凸部155aが形成されて線状部材150に軸方向に収縮する力が生じた際に、延在領域150Bの基端側で伸長することにより、線状部材150からチューブ部材160に対して軸方向に収縮する力が作用することを防止する。   For example, when the deformation region 150A of the linear member 150 forms the convex portion 155a, an extension region that extends in the axial direction along with the deformation of the deformation region 150A is provided on the proximal end side of the extension region 150B. Also good. The extension region is formed by extending on the proximal end side of the extension region 150B when the convex portion 155a is formed in the deformation region 150A of the linear member 150 and the linear member 150 is contracted in the axial direction. Further, the contraction force in the axial direction from the linear member 150 to the tube member 160 is prevented from acting.
図1および図2(A)に示すように、チューブ部材160の先端部162は、拡張部材130の拡張本体部131の先端付近に配置している。また、図1に示すように、チューブ部材160の基端部163は、耐キンクプロテクタ180の先端付近に配置している。なお、チューブ部材160は、図2(A)に示すように、先端が閉塞(封止)していてもよいし、先端に開口部が形成されていてもよい。同様に、チューブ部材160は、基端が閉塞していてもよいし、基端に開口部が形成されていてもよい。   As shown in FIGS. 1 and 2A, the distal end portion 162 of the tube member 160 is disposed near the distal end of the expansion main body portion 131 of the expansion member 130. Further, as shown in FIG. 1, the base end portion 163 of the tube member 160 is disposed in the vicinity of the tip end of the kink protector 180. As shown in FIG. 2A, the tube member 160 may be closed (sealed) at the tip, or an opening may be formed at the tip. Similarly, the tube member 160 may have a proximal end closed or an opening formed at the proximal end.
チューブ部材160の先端部162は、拡張部材130の外表面に固定している。また、チューブ部材160の基端部163は、シャフト100の外表面に固定している。チューブ部材160の固定は、例えば、融着や接着により行うことができる。   The distal end portion 162 of the tube member 160 is fixed to the outer surface of the expansion member 130. Further, the base end portion 163 of the tube member 160 is fixed to the outer surface of the shaft 100. The tube member 160 can be fixed by, for example, fusion or adhesion.
図2(A)に示すように、チューブ部材160の内腔165に配置した線状部材150の先端部152は、チューブ部材160の先端部162付近に配置している。なお、線状部材150の基端部は、図示省略するが、チューブ部材160の基端部163付近に配置している(図1を参照)。   As shown in FIG. 2A, the distal end portion 152 of the linear member 150 disposed in the lumen 165 of the tube member 160 is disposed in the vicinity of the distal end portion 162 of the tube member 160. Although the base end portion of the linear member 150 is not shown, it is disposed near the base end portion 163 of the tube member 160 (see FIG. 1).
線状部材150は、拡張部材130の先端側(拡張部材130の軸方向において拡張本体部131の基端よりも先端側)に固定している。例えば、線状部材150の先端部153は、拡張部材130の先端側に配置されたチューブ部材160の先端部162に固定できる。また、例えば、線状部材150の基端部は、チューブ部材160の基端部163に固定できる(図1を参照)。ただし、線状部材150は、線状部材150の少なくとも一部が拡張部材130の先端側またはシャフト100の先端側に固定されていればよく、線状部材150を固定する位置は特に限定されない。   The linear member 150 is fixed to the distal end side of the expansion member 130 (the distal end side from the proximal end of the expansion main body 131 in the axial direction of the expansion member 130). For example, the distal end portion 153 of the linear member 150 can be fixed to the distal end portion 162 of the tube member 160 disposed on the distal end side of the expansion member 130. Further, for example, the base end portion of the linear member 150 can be fixed to the base end portion 163 of the tube member 160 (see FIG. 1). However, in the linear member 150, at least a part of the linear member 150 may be fixed to the distal end side of the expansion member 130 or the distal end side of the shaft 100, and the position where the linear member 150 is fixed is not particularly limited.
なお、医療用長尺体10にチューブ部材160が設けられていない場合、線状部材150は、拡張部材130やシャフト100に直接固定してもよいし、線状部材150が凸部155aを形成するのを妨げることのないように配置される他の部材を介して拡張部材130やシャフト100に固定してもよい。   In addition, when the tube member 160 is not provided in the medical elongate body 10, the linear member 150 may be directly fixed to the expansion member 130 or the shaft 100, or the linear member 150 forms the convex portion 155a. It may be fixed to the expansion member 130 or the shaft 100 via another member that is arranged so as not to hinder.
図3(B)に示すように、線状部材150およびチューブ部材160は、例えば、拡張部材130が拡張した際、拡張部材130の外周方向に均等な間隔を空けて配置される。本実施形態においては、拡張部材130に3つの線状部材150および3つのチューブ部材160を設けている。このため、各線状部材150および各チューブ部材160は、各線状部材150および各チューブ部材160の間に拡張部材130の外周方向に沿って120°の均等な角度差が形成されるように配置している。   As shown in FIG. 3B, for example, when the expansion member 130 is expanded, the linear member 150 and the tube member 160 are arranged at equal intervals in the outer circumferential direction of the expansion member 130. In the present embodiment, the expansion member 130 is provided with three linear members 150 and three tube members 160. For this reason, the linear members 150 and the tube members 160 are arranged such that an equal angular difference of 120 ° is formed between the linear members 150 and the tube members 160 along the outer circumferential direction of the expansion member 130. ing.
また、本実施形態では、線状部材150は、図3(B)に示す軸直交断面において、シャフト100の軸心(内管シャフト120の軸心)c1に対して内管シャフト120の基端開口部105と異なる位置に配置している。図3(B)には、内管シャフト120の基端開口部105の位置する方向を仮想線で例示している。   Further, in the present embodiment, the linear member 150 has a proximal end of the inner tube shaft 120 with respect to the shaft center (the shaft center of the inner tube shaft 120) c1 of the shaft 100 in the axis orthogonal cross section shown in FIG. It is arranged at a position different from the opening 105. In FIG. 3B, the direction in which the proximal end opening 105 of the inner tube shaft 120 is located is illustrated by a virtual line.
線状部材150は、拡張部材130が拡張した状態において、シャフト100の外周方向で内管シャフト120の基端開口部105と重ならないように、内管シャフト120の基端開口部105との間に所定の角度差(例えば、45°前後)を設けて配置している。本実施形態では3つの線状部材150を拡張部材130に配置しているため、全ての線状部材150と内管シャフト120の基端開口部105とがシャフト100の外周方向で重ならないように、各線状部材150を配置している。   The linear member 150 is disposed between the proximal end opening 105 of the inner tube shaft 120 so that the linear member 150 does not overlap the proximal end opening 105 of the inner tube shaft 120 in the outer circumferential direction of the shaft 100 in a state where the expansion member 130 is expanded. Are arranged with a predetermined angular difference (for example, around 45 °). In this embodiment, since three linear members 150 are arranged on the expansion member 130, all the linear members 150 and the proximal end opening 105 of the inner tube shaft 120 do not overlap in the outer peripheral direction of the shaft 100. Each linear member 150 is arranged.
なお、線状部材150の配置は、線状部材150の変形領域150Aの少なくとも一部が拡張部材130の拡張本体部131と周方向において重なるように配置される限り、特に限定されない。また、一つの拡張部材130に配置する線状部材150の個数等も特に限定されない。ただし、線状部材150は、拡張部材130に形成される羽根部140の個数と同数設けることが好ましい。これにより、拡張部材130は、線状部材150が形成する凸部155aにより、狭窄部に対する拡張力が好適に向上する。   The arrangement of the linear member 150 is not particularly limited as long as at least a part of the deformation region 150A of the linear member 150 is arranged so as to overlap the expansion main body 131 of the expansion member 130 in the circumferential direction. In addition, the number of linear members 150 arranged on one expansion member 130 is not particularly limited. However, the number of linear members 150 is preferably the same as the number of blade portions 140 formed on the expansion member 130. Thereby, the expansion force with respect to a constriction part improves suitably for the expansion member 130 by the convex part 155a which the linear member 150 forms.
線状部材150は、図3(B)に示すように、拡張部材130が拡張して、拡張部材130の羽根部140による凸部155aの形成が阻害(抑制)された状態が解除されると、変形領域150Aにコイル部155を形成し、チューブ部材160の内腔165で放射方向に広がる。チューブ部材160は、線状部材150がコイル部155を形成すると、コイル部155により放射方向に押し広げられて、その内径および外径が大きくなるように変形する。線状部材150は、拡張部材130が拡張した際、上記のようにチューブ部材160が変形することにより、コイル部155の形成が阻害されず、変形領域150Aに凸部155aを円滑に形成できる。   As shown in FIG. 3B, the linear member 150 is expanded when the expansion member 130 is expanded and the state in which the formation of the convex portion 155a by the blade portion 140 of the expansion member 130 is inhibited (suppressed) is released. The coil portion 155 is formed in the deformation region 150A and spreads in the radial direction in the lumen 165 of the tube member 160. When the linear member 150 forms the coil portion 155, the tube member 160 is expanded in the radial direction by the coil portion 155 and deformed so that its inner diameter and outer diameter are increased. In the linear member 150, when the expansion member 130 is expanded, the tube member 160 is deformed as described above, so that the formation of the coil portion 155 is not hindered, and the convex portion 155a can be smoothly formed in the deformation region 150A.
なお、上記のように、拡張部材130が拡張した際に、チューブ部材160により線状部材150の変形が阻害されることを防止するために、チューブ部材160は、例えば、線状部材150が自然状態で放射方向に付与する力で容易に内径および外径が広がる程度の柔軟性を有するように形成することが好ましい。   As described above, in order to prevent the deformation of the linear member 150 by the tube member 160 when the expansion member 130 is expanded, the tube member 160 is, for example, a natural member 150. It is preferable to form such that the inner diameter and the outer diameter are easily expanded by the force applied in the radial direction in the state.
図3(A)に示すように、チューブ部材160は、拡張部材130の外表面に配置された第1領域160Aと、第1領域160Aの基端側に位置し、シャフト100の外表面に配置された第2領域160Bと、を有している。   As shown in FIG. 3A, the tube member 160 is disposed on the outer surface of the shaft 100 and is positioned on the proximal side of the first region 160A disposed on the outer surface of the expansion member 130 and the first region 160A. Second region 160B.
チューブ部材160の第1領域160Aの内径は、図3(A)に示すように、拡張部材130の拡張状態において、第2領域160Bの内径よりも大きくなる。同様に、チューブ部材160の第1領域160Aの外径は、拡張部材130の拡張状態において、第2領域160Bの外径よりも大きくなる。   As shown in FIG. 3A, the inner diameter of the first region 160A of the tube member 160 is larger than the inner diameter of the second region 160B when the expansion member 130 is in the expanded state. Similarly, the outer diameter of the first region 160A of the tube member 160 is larger than the outer diameter of the second region 160B when the expansion member 130 is in the expanded state.
図3(A)に示すように、チューブ部材160の第1領域160Aは、線状部材150の変形領域150Aと周方向において重なる位置に配置している。また、チューブ部材160の第2領域160Bは、線状部材150の延在領域150Bと周方向において重なる位置に配置している。   As shown in FIG. 3A, the first region 160A of the tube member 160 is disposed at a position overlapping the deformation region 150A of the linear member 150 in the circumferential direction. Further, the second region 160B of the tube member 160 is disposed at a position overlapping with the extending region 150B of the linear member 150 in the circumferential direction.
図2(A)に示すように、チューブ部材160の第1領域160Aとチューブ部材160の第2領域160Bは、拡張部材130が収縮した状態では、略同一の内径および外径を有している。   As shown in FIG. 2A, the first region 160A of the tube member 160 and the second region 160B of the tube member 160 have substantially the same inner and outer diameters when the expansion member 130 is contracted. .
上述した通り、拡張部材130が拡張した状態におけるチューブ部材160の第1領域160Aの内径は、狭窄部の拡張性の観点から、拡張部材130が拡張した状態におけるチューブ部材160の第2領域160Bの内径よりも大きい方が好ましい。なお、拡張部材130が拡張した状態におけるチューブ部材160の第1領域160Aの内径は、拡張部材130が拡張した状態におけるチューブ部材160の第2領域160Bの内径と同じであってもよい。   As described above, the inner diameter of the first region 160A of the tube member 160 when the expansion member 130 is expanded is the same as that of the second region 160B of the tube member 160 when the expansion member 130 is expanded from the viewpoint of expandability of the narrowed portion. Larger than the inner diameter is preferred. Note that the inner diameter of the first region 160A of the tube member 160 when the expansion member 130 is expanded may be the same as the inner diameter of the second region 160B of the tube member 160 when the expansion member 130 is expanded.
次に、医療用長尺体10の構成材料を説明する。   Next, the constituent material of the medical long body 10 will be described.
外管シャフト110は、例えば、ポリエチレン、ポリプロピレン、エチレン−プロピレン共重合体、エチレン−酢酸ビニル共重合体等のポリオレフィン、軟質ポリ塩化ビニル等の熱可塑性樹脂、ポリウレタンエラストマー、ポリアミドエラストマー、ポリエステルエラストマー等の各種エラストマー、ポリアミド、結晶性ポリエチレン、結晶性ポリプロピレン等の結晶性プラスチック等で形成できる。   The outer tube shaft 110 is made of, for example, polyolefin such as polyethylene, polypropylene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, thermoplastic resin such as soft polyvinyl chloride, polyurethane elastomer, polyamide elastomer, polyester elastomer, etc. It can be formed from various elastomers, polyamides, crystalline plastics such as crystalline polyethylene and crystalline polypropylene.
内管シャフト120は、例えば、外管シャフト110の構成材料として例示した上記の材料と同様のもので形成できる。   The inner tube shaft 120 can be formed of, for example, the same material as that exemplified as the constituent material of the outer tube shaft 110.
拡張部材130は、例えば、ポリエチレン、ポリプロピレン、エチレン−プロピレン共重合体のポリオレフィン、ポリエチレンテレフタレート等のポリエステル、ポリ塩化ビニル、エチレン−酢酸ビニル共重合体、架橋型エチレン−酢酸ビニル共重合体、ポリウレタン等の熱可塑性樹脂、ポリアミド、ポリアミドエラストマー、ポリスチレンエラストマー、シリコーンゴム、ラテックスゴム等で形成できる。   The expansion member 130 is, for example, polyethylene, polypropylene, polyolefin of ethylene-propylene copolymer, polyester such as polyethylene terephthalate, polyvinyl chloride, ethylene-vinyl acetate copolymer, cross-linked ethylene-vinyl acetate copolymer, polyurethane, etc. The thermoplastic resin, polyamide, polyamide elastomer, polystyrene elastomer, silicone rubber, latex rubber and the like can be used.
チューブ部材160は、例えば、拡張部材130の構成材料として例示した上記の材料と同様のもので形成できる。   The tube member 160 can be formed of, for example, the same material as that exemplified above as the constituent material of the expansion member 130.
線状部材150は、例えば、形状記憶合金や超弾性合金等で形成できる。形状記憶合金、超弾性合金としては、例えば、チタン系(Ti−Ni、Ti−Pd、Ti−Nb−Sn等)や、銅系の合金を用いることができる。また、線状部材150は、例えば、ステンレス鋼(SUS304)、βチタン鋼、Co−Cr合金、ニッケルチタン合金等のバネ性を有する合金でも形成できる。また、線状部材150は、例えば、アクリル系樹脂、トランスイソプレンポリマー、ポリノルボルネン、スチレン−ブタジエン共重合体、ポリウレタン等の形状記憶ポリマーでも形成できる。   The linear member 150 can be formed of, for example, a shape memory alloy or a superelastic alloy. As the shape memory alloy and the superelastic alloy, for example, a titanium-based (Ti—Ni, Ti—Pd, Ti—Nb—Sn, etc.) or a copper-based alloy can be used. Further, the linear member 150 can be formed of an alloy having spring properties such as stainless steel (SUS304), β titanium steel, Co—Cr alloy, nickel titanium alloy, and the like. The linear member 150 can also be formed of a shape memory polymer such as acrylic resin, transisoprene polymer, polynorbornene, styrene-butadiene copolymer, polyurethane, and the like.
次に、本実施形態に係る医療用長尺体10の作用を説明する。   Next, the effect | action of the medical elongate body 10 which concerns on this embodiment is demonstrated.
本実施形態に係る医療用長尺体10は、シャフト100と、シャフト100の先端部に固定された拡張部材130と、拡張部材130の先端側に固定され、少なくとも一部が拡張部材130の外表面側に配置された線状部材150と、を備えている。また、拡張部材130は、シャフト100に複数の羽根部140を巻きつけるように配置された収縮状態と、シャフト100の放射方向に拡張した拡張状態と、を有する。また、線状部材150は、拡張部材130の周方向において拡張部材130と重なる位置に、自然状態で凸部155aを形成する変形領域150Aを有している。そして、変形領域150Aは、拡張部材130の収縮状態において、凸部155aを形成することを阻害されつつ、拡張部材130の隣り合う羽根部140の間に配置され、拡張部材130の拡張状態において、拡張部材130が放射方向に拡張することにより、拡張部材130の外表面側で凸部155aを形成する。   The medical long body 10 according to the present embodiment includes a shaft 100, an expansion member 130 fixed to the distal end portion of the shaft 100, and a distal end side of the expansion member 130, and at least a part of the medical elongated body 10 is outside the expansion member 130. And a linear member 150 disposed on the surface side. The expansion member 130 has a contracted state in which the plurality of blade portions 140 are wound around the shaft 100 and an expanded state in which the shaft 100 is expanded in the radial direction. Further, the linear member 150 has a deformation region 150 </ b> A that forms the convex portion 155 a in a natural state at a position overlapping the expansion member 130 in the circumferential direction of the expansion member 130. And the deformation | transformation area | region 150A is arrange | positioned between the adjacent blade | wing parts 140 of the expansion member 130, preventing formation of the convex part 155a in the contracted state of the expansion member 130, and in the expansion state of the expansion member 130, As the expansion member 130 expands in the radial direction, a convex portion 155 a is formed on the outer surface side of the expansion member 130.
本実施形態に係る医療用長尺体10は、狭窄部を拡張する際、線状部材150が拡張部材130の外表面側で凸部155aを形成するため、狭窄部に対する拡張部材130の拡張力が向上する。また、本実施形態に係る医療用長尺体10は、狭窄部まで拡張部材130を送達する際、線状部材150が拡張部材130の外表面側で凸部155aを形成しないようにその変形が阻害されるため、拡張部材130の外径が大きくなるのを防止でき、生体管腔での通過性が向上する。   In the medical long body 10 according to the present embodiment, when the stenosis portion is expanded, the linear member 150 forms the convex portion 155a on the outer surface side of the expansion member 130, so that the expansion force of the expansion member 130 on the stenosis portion Will improve. Further, the medical elongated body 10 according to the present embodiment is deformed so that the linear member 150 does not form the convex portion 155a on the outer surface side of the expansion member 130 when the expansion member 130 is delivered to the stenosis. Since it is inhibited, it is possible to prevent the outer diameter of the expansion member 130 from increasing, and the passage through the living body lumen is improved.
また、医療用長尺体10は、拡張部材130の外表面およびシャフト100の外表面に配置されたチューブ部材160を有しており、線状部材150はチューブ部材160の内腔165に配置される。   In addition, the medical elongated body 10 includes a tube member 160 disposed on the outer surface of the expansion member 130 and the outer surface of the shaft 100, and the linear member 150 is disposed in the inner cavity 165 of the tube member 160. The
上記のように構成した医療用長尺体10は、線状部材150がチューブ部材160の内腔165に配置されているため、拡張部材130が拡張するとともに線状部材150が凸部155aを形成した状態で、凸部155aがチューブ部材160から露出することを防止できる。このため、医療用長尺体10は、拡張部材130を拡張した後、当該医療用長尺体10を生体管腔から抜去等する際に、凸部155aが引っ掛かるなどして抜去が妨げられるのを防止できる。これにより、医師等の術者は、医療用長尺体10を生体管腔から円滑に抜去することができる。さらに、線状部材150は、チューブ部材160の内腔165で凸部155aを形成することにより、チューブ部材160の内表面側からチューブ部材160の外表面側へ向けてチューブ部材160を狭窄部に対して押し付けるため、チューブ部材160の外表面と狭窄部とが面接触して両者の接触面積が大きくなる。このため、医療用長尺体10は、狭窄部の比較的広い範囲に亘って均等な拡張力を作用させることができ、狭窄部を効果的に拡張できる。   In the medical elongated body 10 configured as described above, since the linear member 150 is disposed in the lumen 165 of the tube member 160, the expansion member 130 expands and the linear member 150 forms a convex portion 155a. In this state, the protrusion 155a can be prevented from being exposed from the tube member 160. For this reason, when the medical long body 10 is expanded from the living body lumen after the expansion member 130 is expanded, the removal of the medical long body 10 is hindered due to the protrusion 155a being caught. Can be prevented. Thereby, an operator such as a doctor can smoothly remove the medical long body 10 from the living body lumen. Furthermore, the linear member 150 forms the convex portion 155a in the inner cavity 165 of the tube member 160, so that the tube member 160 becomes a constricted portion from the inner surface side of the tube member 160 toward the outer surface side of the tube member 160. Since it presses against, the outer surface of the tube member 160 and a constriction part surface-contact, and both contact area becomes large. For this reason, the medical elongate body 10 can apply an equal expansion force over a relatively wide range of the stenosis, and can effectively expand the stenosis.
また、医療用長尺体10のチューブ部材160は、拡張部材130の外表面に配置された第1領域160Aと、第1領域160Aの基端側に位置し、シャフト100の外表面に配置された第2領域160Bと、を有している。そして、第1領域160Aの内径は、拡張部材130の拡張状態において、第2領域160Bの内径よりも大きなものとなる。   In addition, the tube member 160 of the medical elongated body 10 is positioned on the outer surface of the shaft 100 and is positioned on the proximal end side of the first region 160A and the first region 160A disposed on the outer surface of the expansion member 130. And a second region 160B. The inner diameter of the first region 160A is larger than the inner diameter of the second region 160B when the expansion member 130 is expanded.
上記のように構成した医療用長尺体10は、拡張部材130が拡張すると、拡張部材130の外表面に配置されたチューブ部材160の第1領域160Aの内径がシャフト100の外表面に配置されたチューブ部材160の第2領域160Bの内径よりも大きくなる。このため、線状部材150は、拡張部材130が拡張した際、チューブ部材160の第1領域160Aで円滑に凸部155aを形成できる。これにより、医療用長尺体10は、拡張部材130が拡張した際、拡張部材130および凸部155aにより狭窄部を効率良く拡張できる。   When the expansion member 130 expands, the medical elongated body 10 configured as described above has the inner diameter of the first region 160A of the tube member 160 disposed on the outer surface of the expansion member 130 disposed on the outer surface of the shaft 100. The inner diameter of the second region 160B of the tube member 160 becomes larger. For this reason, the linear member 150 can smoothly form the convex portion 155a in the first region 160A of the tube member 160 when the expansion member 130 is expanded. Thereby, when the expansion member 130 expands, the medical elongate body 10 can expand a constriction part efficiently by the expansion member 130 and the convex part 155a.
また、線状部材150の変形領域150Aは、自然状態で複数の凸部155aを形成するコイル部155であり、線状部材150は、拡張部材130の収縮状態において、コイル部155が軸方向に伸長された状態で、拡張部材130の隣り合う羽根部140の間に配置され、拡張部材130の拡張状態において、拡張部材130の外表面側でコイル部155を形成する。   The deformation region 150A of the linear member 150 is a coil portion 155 that forms a plurality of convex portions 155a in a natural state, and the linear member 150 has the coil portion 155 in the axial direction in the contracted state of the expansion member 130. In an expanded state, the coil member 155 is disposed between adjacent blade portions 140 of the expansion member 130, and in the expanded state of the expansion member 130, a coil portion 155 is formed on the outer surface side of the expansion member 130.
上記のように構成した医療用長尺体10は、拡張部材130が拡張した際、線状部材150の変形領域150Aを形成するコイル部155が複数の凸部155aを形成する。このため、医療用長尺体10は、線状部材150の複数の凸部155aから狭窄部に対して効率良く拡張力を付与できる。さらに、線状部材150の変形領域150Aを形成するコイル部155は、拡張部材130が収縮した状態で拡張部材130の隣り合う羽根部140の間に配置される。このため、医療用長尺体10は、拡張部材130が収縮した状態で、コイル部155により送達性が低下することを防止できる。   In the medical elongated body 10 configured as described above, when the expansion member 130 is expanded, the coil portion 155 that forms the deformation region 150A of the linear member 150 forms a plurality of convex portions 155a. For this reason, the medical elongated body 10 can efficiently apply an expansion force to the narrowed portion from the plurality of convex portions 155a of the linear member 150. Further, the coil portion 155 forming the deformation region 150A of the linear member 150 is disposed between the adjacent blade portions 140 of the expansion member 130 in a state where the expansion member 130 is contracted. For this reason, the medical elongated body 10 can prevent the delivery performance from being lowered by the coil portion 155 in a state where the expansion member 130 is contracted.
また、拡張部材130は、拡張部材130の収縮状態において、隣り合う羽根部140同士を固定する仮固定部145を有し、仮固定部145による隣り合う羽根部140同士の固定は、拡張部材130の拡張状態において、解除される。   The expansion member 130 has a temporary fixing portion 145 that fixes adjacent blade portions 140 in a contracted state of the expansion member 130, and the fixing of the adjacent blade portions 140 by the temporary fixing portion 145 is performed by the expansion member 130. It is released in the expanded state.
上記のように構成した医療用長尺体10は、拡張部材130が収縮した状態で、拡張部材130の隣り合う羽根部140同士が仮固定部145により固定されているため、医師等の術者は、医療用長尺体10を狭窄部へ送達する際に拡張部材130の羽根部140が不用意に広がって線状部材150が意図せずに凸部155aを形成するのを防止できる。これにより、術者は、医療用長尺体10の拡張部材130を容易かつ円滑に狭窄部まで送達できる。   Since the medical elongate body 10 configured as described above is in a state where the expansion member 130 is contracted, the adjacent blade portions 140 of the expansion member 130 are fixed by the temporary fixing portion 145. When the medical elongated body 10 is delivered to the constriction, it is possible to prevent the blade member 140 of the expansion member 130 from unintentionally spreading and the linear member 150 from forming the convex portion 155a unintentionally. As a result, the surgeon can easily and smoothly deliver the expansion member 130 of the medical elongated body 10 to the stenosis.
また、シャフト100は、外管シャフト110と、外管シャフト110の内腔115に配置された内管シャフト120と、を有している。内管シャフト120は、外管シャフト110の途中で開口する基端開口部105を有し、線状部材150は、シャフト100の軸心に垂直な断面において、シャフト100の軸心に対して基端開口部105と異なる位置に配置される。   The shaft 100 includes an outer tube shaft 110 and an inner tube shaft 120 disposed in the inner lumen 115 of the outer tube shaft 110. The inner tube shaft 120 has a proximal end opening 105 that opens in the middle of the outer tube shaft 110, and the linear member 150 has a base that is perpendicular to the axis of the shaft 100 in a cross section perpendicular to the axis of the shaft 100. It is arranged at a position different from the end opening 105.
上記のように構成した医療用長尺体10は、内管シャフト120の基端開口部105と線状部材150とがシャフト100の周方向で重なる位置に配置されなくなる。このため、医療用長尺体10は、内管シャフト120の基端開口部105にガイドワイヤ200を挿通させる際、ガイドワイヤ200が線状部材150と干渉するのを防止でき、ガイドワイヤ200を円滑に基端開口部105に挿入できる。   The medical elongated body 10 configured as described above is not disposed at a position where the proximal end opening 105 of the inner tube shaft 120 and the linear member 150 overlap in the circumferential direction of the shaft 100. For this reason, the medical elongated body 10 can prevent the guide wire 200 from interfering with the linear member 150 when the guide wire 200 is inserted through the proximal end opening 105 of the inner tube shaft 120. The base end opening 105 can be smoothly inserted.
次に、上述した実施形態の変形例を説明する。なお、各変形例において特に言及しない構成や部材については、前述した実施形態と同様のものとすることができ、その説明を省略する。   Next, a modified example of the above-described embodiment will be described. In addition, about the structure and member which are not mentioned especially in each modification, it can be set as the thing similar to embodiment mentioned above, The description is abbreviate | omitted.
<変形例1>
図4および図5を参照して、変形例1に係る医療用長尺体を説明する。
<Modification 1>
With reference to FIG. 4 and FIG. 5, the medical elongate body which concerns on the modification 1 is demonstrated.
図4(A)は、収縮した状態の拡張部材130を示す軸直交断面図、図4(B)は、拡張した状態の拡張部材130を示す軸直交断面図、図5は、拡張した状態の拡張部材130の軸方向の断面図である。   4A is an axial orthogonal sectional view showing the expanded member 130 in a contracted state, FIG. 4B is an axial orthogonal sectional view showing the expanded member 130 in an expanded state, and FIG. 5 is an expanded state. FIG. 5 is a cross-sectional view of the expansion member 130 in the axial direction.
前述した実施形態では、線状部材150のコイル部155は、拡張部材130が拡張した際、チューブ部材160の内周面に沿って円形に巻回するように変形して凸部155aを形成した(図3(A)および図3(B)を参照)。一方、本変形例に係る医療用長尺体は、コイル部355が自然状態において楕円形状を形成する。   In the above-described embodiment, the coil portion 155 of the linear member 150 is deformed so as to be wound in a circle along the inner peripheral surface of the tube member 160 when the expansion member 130 is expanded to form the convex portion 155a. (See FIGS. 3A and 3B). On the other hand, in the medical elongated body according to this modification, the coil portion 355 forms an elliptical shape in a natural state.
図4(B)および図5に示すように、線状部材150は、自然状態で変形領域150Aにコイル部355を形成する。コイル部355は、拡張部材130が拡張すると、拡張部材130およびシャフト100の周方向に沿って楕円形状に巻回する。   As shown in FIGS. 4B and 5, the linear member 150 forms a coil portion 355 in the deformation region 150A in a natural state. When the expansion member 130 expands, the coil portion 355 is wound in an elliptical shape along the circumferential direction of the expansion member 130 and the shaft 100.
図4(A)および図4(B)に示すように、チューブ部材160は、コイル部355が形成する楕円形状に合わせて、軸直交断面の形状を楕円形状に形成している。チューブ部材160は、図4(A)に示すように、拡張部材130が収縮した状態では、拡張部材130の隣り合う羽根部140の間に収縮した状態で配置される。また、チューブ部材160は、図4(B)に示すように、拡張部材130が拡張した状態では、軸直交断面における楕円形状の長軸方向および短軸方向の寸法が大きくなるように拡張する。   As shown in FIGS. 4A and 4B, the tube member 160 has an elliptical cross-sectional shape in accordance with the elliptical shape formed by the coil portion 355. As shown in FIG. 4A, the tube member 160 is disposed in a contracted state between adjacent blade portions 140 of the expansion member 130 when the expansion member 130 is contracted. Further, as shown in FIG. 4B, the tube member 160 expands so that the dimensions of the major axis direction and the minor axis direction of the elliptical shape in the axis-orthogonal cross section are increased in a state where the expansion member 130 is expanded.
各線状部材150および各チューブ部材160は、拡張部材130が拡張した状態において、軸直交断面における楕円形状の長軸が内管シャフト120の軸心c1を通る垂線H1に重なるように配置されることが好ましい。これにより、拡張部材130は、拡張部材130の外表面側で楕円形状の長軸上に位置する端部を狭窄部に接触させながら拡張することができるため、狭窄部を効果的に拡張できる。   Each linear member 150 and each tube member 160 are arranged such that, in a state where the expansion member 130 is expanded, the elliptical long axis in the axial orthogonal cross section overlaps the perpendicular H1 passing through the axis c1 of the inner tube shaft 120. Is preferred. As a result, the expansion member 130 can be expanded while the end located on the long axis of the elliptical shape on the outer surface side of the expansion member 130 is brought into contact with the stenosis, so that the stenosis can be effectively expanded.
以上のように本変形例に係る医療用長尺体は、コイル部355が自然状態において楕円形状の凸部155aを形成する。このため、医療用長尺体は、拡張部材130が拡張した際、コイル部355が形成する凸部155aにより、狭窄部に対する拡張力が向上し、狭窄部をより一層効率良く拡張できる。   As described above, in the medical elongated body according to this modification, the coil portion 355 forms the elliptical convex portion 155a in the natural state. For this reason, when the expansion member 130 expands, the medical elongated body can be expanded more efficiently because the convex portion 155a formed by the coil portion 355 improves the expansion force with respect to the narrowed portion.
<変形例2>
図6および図7を参照して、変形例2に係る医療用長尺体を説明する。
<Modification 2>
With reference to FIG. 6 and FIG. 7, the medical elongate body which concerns on the modification 2 is demonstrated.
図6(A)は、収縮した状態の拡張部材130を示す軸直交断面図、図6(B)は、拡張した状態の拡張部材130を示す軸直交断面図、図7は、拡張した状態の拡張部材130の軸方向の断面図である。   6A is an axial orthogonal sectional view showing the expanded member 130 in a contracted state, FIG. 6B is an axial orthogonal sectional view showing the expanded member 130 in an expanded state, and FIG. 7 is an expanded state. FIG. 5 is a cross-sectional view of the expansion member 130 in the axial direction.
本変形例に係る医療用長尺体は、図6(B)および図7に示すように、コイル部455が自然状態において三角形状を形成する。   As shown in FIGS. 6B and 7, in the medical long body according to this modification, the coil portion 455 forms a triangular shape in a natural state.
図6(B)および図7に示すように、線状部材150は、自然状態で変形領域150Aにコイル部455を形成する。コイル部455は、拡張部材130が拡張すると、拡張部材130およびシャフト100の周方向に沿って三角形状に巻回する。   As shown in FIGS. 6B and 7, the linear member 150 forms a coil portion 455 in the deformation region 150A in a natural state. When the expansion member 130 expands, the coil portion 455 is wound in a triangular shape along the circumferential direction of the expansion member 130 and the shaft 100.
図6(A)および図6(B)に示すように、チューブ部材160は、コイル部455が形成する三角形状に合わせて、軸直交断面の形状を三角形に形成している。チューブ部材160は、図6(A)に示すように、拡張部材130が収縮した状態では、拡張部材130の隣り合う羽根部140の間に収縮した状態で配置される。また、チューブ部材160は、図6(B)に示すように、拡張部材130が拡張した状態では、拡張部材130の外表面側で拡張するように変形する。   As shown in FIGS. 6A and 6B, the tube member 160 has a triangular shape in the cross section perpendicular to the axis in accordance with the triangular shape formed by the coil portion 455. As shown in FIG. 6A, the tube member 160 is disposed in a contracted state between adjacent blade portions 140 of the expansion member 130 when the expansion member 130 is contracted. Further, as shown in FIG. 6B, the tube member 160 is deformed so as to expand on the outer surface side of the expansion member 130 when the expansion member 130 is expanded.
各線状部材150および各チューブ部材160は、拡張部材130が拡張した状態において、シャフト100の軸心(内管シャフト120の軸心)c1から放射方向に向けて配置された三角形状の頂点が内管シャフト120の軸心c1を通る垂線H1に重なるように配置されることが好ましい。これにより、拡張部材130は、拡張部材130の外表面側でコイル部455の三角形上の頂点を狭窄部に接触させながら拡張することができるため、狭窄部を効果的に拡張できる。   Each linear member 150 and each tube member 160 has triangular apexes arranged radially from the axial center of the shaft 100 (axial center of the inner tube shaft 120) c1 in the state where the expansion member 130 is expanded. It is preferably arranged so as to overlap a perpendicular line H1 passing through the axis c1 of the tube shaft 120. Accordingly, the expansion member 130 can be expanded while the apex on the triangle of the coil portion 455 on the outer surface side of the expansion member 130 is in contact with the stenosis portion, so that the stenosis portion can be effectively expanded.
以上のように、本変形例に係る医療用長尺体は、コイル部455が自然状態において三角形状の凸部155aを形成する。このため、医療用長尺体は、拡張部材130が拡張した際、コイル部455が形成する凸部155aの頂点部を狭窄部に対して押し付けることにより、狭窄部に対する拡張力が向上し、狭窄部をより一層効率良く拡張できる。   As described above, in the medical elongated body according to this modification, the coil portion 455 forms the triangular convex portion 155a in the natural state. For this reason, when the expansion member 130 expands, the medical elongated body improves the expansion force with respect to the stenosis portion by pressing the apex portion of the convex portion 155a formed by the coil portion 455 against the stenosis portion. The part can be expanded more efficiently.
<変形例3>
以下、図8を参照して、変形例3に係る医療用長尺体500を説明する。
<Modification 3>
Hereinafter, with reference to FIG. 8, the medical elongate body 500 which concerns on the modification 3 is demonstrated.
図8に示すように、本変形例に係る医療用長尺体500は、シャフト100の基端部に配置されたハブ190と、線状部材150に接続され、ハブ190に対して進退移動可能な操作部材595と、を有している。   As shown in FIG. 8, the medical elongated body 500 according to this modification is connected to the hub 190 disposed at the proximal end portion of the shaft 100 and the linear member 150, and can move forward and backward with respect to the hub 190. An operation member 595.
図8においては図示省略しているが、医療用長尺体500は、前述した実施形態にと同様に、拡張部材130の周方向の異なる位置に3つの線状部材150および3つのチューブ部材160を有している(図2(B)および図3(B)を参照)。   Although not shown in FIG. 8, the medical elongated body 500 includes three linear members 150 and three tube members 160 at different positions in the circumferential direction of the expansion member 130 as in the above-described embodiment. (See FIG. 2B and FIG. 3B).
3つの線状部材150の各々は、耐キンクプロテクタ180の先端側に配置したチューブ部材160の基端開口部163aから基端側へ導出している。操作部材595は、各チューブ部材160から導出された線状部材150と接続している。また、操作部材595には、操作部材595のハブ190に対する進退移動(軸方向の先端側および基端側への移動)を可能にする挿通孔595aを形成している。挿通孔595aは、操作部材595が進退移動する際、その内側にハブ190を挿通させることにより、ハブ190と操作部材595とが干渉するのを防止する。   Each of the three linear members 150 is led out from the proximal end opening 163a of the tube member 160 disposed on the distal end side of the kink protector 180 to the proximal end side. The operation member 595 is connected to the linear member 150 led out from each tube member 160. Further, the operation member 595 is formed with an insertion hole 595a that allows the operation member 595 to move forward and backward (moving toward the distal end side and the proximal end side in the axial direction) with respect to the hub 190. The insertion hole 595a prevents the hub 190 and the operation member 595 from interfering with each other by inserting the hub 190 inside the operation member 595 when the operation member 595 moves forward and backward.
医師等の術者は、拡張部材130を拡張させた後、例えば、線状部材150が形成した凸部155aを消失させる際に、操作部材595を基端側へ移動させることにより、線状部材150を軸方向に引き伸ばすように変形させることができる。これにより、術者は、線状部材150に凸部155aが形成された状態を解除することができ、線状部材150に凸部155aが形成されていない状態で医療用長尺体500を生体管腔から抜去できる。   After the expansion member 130 is expanded, the surgeon such as a doctor moves the operation member 595 to the proximal end side when the convex portion 155a formed by the linear member 150 disappears, for example. 150 can be deformed to stretch in the axial direction. As a result, the surgeon can release the state in which the convex portion 155a is formed on the linear member 150, and the medical elongated body 500 can be removed from the living body 500 without the convex portion 155a being formed on the linear member 150. Can be removed from the lumen.
なお、医療用長尺体500に複数の線状部材150が備えられる場合、操作部材595は、例えば、各々の線状部材150と接続されるように複数設けることも可能である。ただし、変形例において説明したように、一つの操作部材595に複数の線状部材150を接続することにより、操作部材595の一度の操作で線状部材150から凸部155aを消失させることができるため、複数の線状部材150が設けられる場合、全ての線状部材150を一つの操作部材595に接続することが好ましい。   In addition, when the medical long body 500 is provided with a plurality of linear members 150, a plurality of operation members 595 can be provided so as to be connected to the respective linear members 150, for example. However, as described in the modification, by connecting a plurality of linear members 150 to one operating member 595, the convex portion 155a can be eliminated from the linear member 150 by one operation of the operating member 595. Therefore, when a plurality of linear members 150 are provided, it is preferable to connect all the linear members 150 to one operation member 595.
以上のように、本変形例に係る医療用長尺体500は、シャフト100の基端部に配置されたハブ190と、線状部材150に接続され、ハブ190に対して進退移動可能な操作部材595と、を有している。   As described above, the medical elongated body 500 according to the present modification is connected to the hub 190 disposed at the proximal end portion of the shaft 100 and the linear member 150 and can be moved forward and backward with respect to the hub 190. Member 595.
上記のように構成した医療用長尺体500は、拡張部材130が拡張して線状部材150が凸部155aを形成した状態で、操作部材595をハブ190に対して基端側へ移動させると、線状部材150が基端側へ引き伸ばされて凸部155aを形成した状態を解除できる。このため、医師等の術者は、拡張部材130を一旦拡張させた後、線状部材150が凸部155aを形成していない状態に戻すことができ、凸部155aにより医療用長尺体500の先端側の外径が大きくなることを防止できるため、拡張部材130を一旦拡張させた後においても生体管腔から医療用長尺体500を円滑に抜去できる。   The medical elongated body 500 configured as described above moves the operation member 595 to the proximal end side with respect to the hub 190 in a state where the expansion member 130 is expanded and the linear member 150 forms the convex portion 155a. Then, the state in which the linear member 150 is extended toward the proximal end side to form the convex portion 155a can be released. For this reason, an operator such as a doctor can once return the state in which the linear member 150 does not form the convex portion 155a after expanding the expansion member 130, and the medical elongated body 500 is formed by the convex portion 155a. Therefore, even after the expansion member 130 is once expanded, the medical elongated body 500 can be smoothly removed from the living body lumen.
以上、実施形態および変形例を通じて本発明に係る医療用長尺体を説明したが、本発明は実施形態および変形例で説明した構成のみに限定されることはなく、特許請求の範囲の記載に基づいて適宜変更することが可能である。   As mentioned above, although the medical elongate body which concerns on this invention was demonstrated through embodiment and a modification, this invention is not limited only to the structure demonstrated in embodiment and the modification, and description of a claim It is possible to change appropriately based on this.
各変形例は適宜組み合わせることが可能であり、例えば、一つの医療用長尺体に複数の線状部材を設ける場合、実施形態や変形例で説明した線状部材のうち任意のものを組み合わせることができる。また、例えば、変形例3で示した構成において、変形例1や変形例2で例示した線状部材を組み合わせることも可能である。   Each modification can be combined as appropriate. For example, when a plurality of linear members are provided on one medical elongated body, any one of the linear members described in the embodiments and modifications is combined. Can do. Further, for example, in the configuration shown in the third modification, the linear members exemplified in the first and second modifications can be combined.
また、線状部材は、拡張部材が拡張した状態において、拡張部材の外表面側に凸部を形成する限り、線状部材の断面形状、軸直交断面の厚み(軸直交断面が円形の場合、外径)、軸方向の長さ、自然状態で形成する形状等は特に限定されない。また、例えば、線状部材は複数の線状部材を接続して構成することも可能である。このように線状部材を構成する場合、例えば、変形領域と変形領域以外の領域(部分)を別部材で構成できる。   In addition, in the state in which the linear member is expanded, as long as the convex portion is formed on the outer surface side of the expansion member, the cross-sectional shape of the linear member, the thickness of the axis orthogonal cross section (when the axis orthogonal cross section is circular, The outer diameter), the length in the axial direction, the shape formed in the natural state, and the like are not particularly limited. Further, for example, the linear member can be configured by connecting a plurality of linear members. When the linear member is configured in this way, for example, the deformation region and the region (part) other than the deformation region can be configured by separate members.
また、実施形態および変形例においては、医療用長尺体に線状部材を配置するチューブ部材が設けられた例を示したが、線状部材は、チューブ部材の内腔に配置せず、例えば、バルーンやシャフトに直接配置してもよい。また、医療用長尺体は、チューブ部材を設ける場合においても、チューブ部材が少なくとも拡張部材の外表面およびシャフトの外表面と周方向に重なる範囲(周方向に重なる位置)で形成されている限り、外径、内径、軸方向の長さ等は特に限定されない。   Further, in the embodiment and the modification, an example in which a tube member for arranging a linear member on a medical long body is shown, but the linear member is not arranged in the lumen of the tube member, for example, Alternatively, it may be placed directly on the balloon or shaft. In addition, even when the tube member is provided, the medical elongated body is formed in a range where the tube member overlaps at least the outer surface of the expansion member and the outer surface of the shaft in the circumferential direction (position overlapping in the circumferential direction). The outer diameter, inner diameter, axial length, etc. are not particularly limited.
また、例えば、医療用長尺体は、オーバーザワイヤ型のバルーンカテーテルとして構成することも可能である。   Further, for example, the medical long body can be configured as an over-the-wire type balloon catheter.
また、例えば、実施形態において説明した医療用長尺体の構造や部材の配置等は適宜変更することができ、図示により説明した付加的な部材の使用の省略や、特に説明されなかったその他の付加的な部材の使用等も適宜に行い得る。   In addition, for example, the structure of the medical elongated body described in the embodiment, the arrangement of the members, and the like can be changed as appropriate, omission of use of the additional members described by the illustration, and other not specifically described Use of an additional member etc. can also be performed suitably.
10、500 医療用長尺体、
100 シャフト、
105 基端開口部(内管シャフトの基端開口部)、
110 外管シャフト、
120 内管シャフト、
130 拡張部材、
140 羽根部、
141 空間部、
145 仮固定部、
150 線状部材、
150A 線状部材の変形領域、
150B 線状部材の延在領域、
155、355、455 コイル部、
155a 凸部、
160 チューブ部材、
160A チューブ部材の第1領域、
160B チューブ部材の第2領域、
165 チューブ部材の内腔、
190 ハブ、
200 ガイドワイヤ、
595 操作部材、
595a 挿通孔、
c1 シャフトの軸心。
10,500 medical long body,
100 shaft,
105 base end opening (base end opening of the inner tube shaft),
110 outer tube shaft,
120 inner tube shaft,
130 expansion member,
140 blades,
141 space,
145 Temporary fixing part,
150 linear members,
150A deformation region of the linear member,
150B Extension region of the linear member,
155, 355, 455 coil part,
155a convex portion,
160 tube member,
160A first region of the tube member;
160B the second region of the tube member;
165 lumen of the tube member,
190 hub,
200 guide wire,
595 operation member,
595a insertion hole,
c1 Shaft axis.

Claims (8)

  1. シャフトと、
    前記シャフトの先端部に固定された拡張部材と、
    前記シャフトの先端側または前記拡張部材の先端側に固定され、少なくとも一部が前記拡張部材の外表面側に配置された線状部材と、を備え、
    前記拡張部材は、前記シャフトに複数の羽根部を巻きつけるように配置された収縮状態と、前記シャフトの放射方向に拡張した拡張状態と、を有し、
    前記線状部材は、前記拡張部材の周方向において前記拡張部材と重なる位置に、自然状態で凸部を形成する変形領域を有し、
    前記変形領域は、前記拡張部材の収縮状態において、前記凸部を形成することを阻害されつつ、前記拡張部材の隣り合う羽根部の間に配置され、前記拡張部材の拡張状態において、前記拡張部材が放射方向に拡張することにより、前記拡張部材の外表面側で前記凸部を形成する、医療用長尺体。
    A shaft,
    An expansion member fixed to the tip of the shaft;
    A linear member that is fixed to the distal end side of the shaft or the distal end side of the expansion member, and at least a part of the linear member is disposed on the outer surface side of the expansion member,
    The expansion member has a contracted state arranged so as to wind a plurality of blade portions around the shaft, and an expanded state expanded in the radial direction of the shaft,
    The linear member has a deformation region that forms a convex portion in a natural state at a position overlapping the expansion member in the circumferential direction of the expansion member,
    The deformation region is disposed between adjacent blade portions of the expansion member while being inhibited from forming the convex portion in the contracted state of the expansion member, and in the expansion state of the expansion member, the expansion member The medical elongate body which forms the said convex part in the outer surface side of the said expansion member by expanding in a radial direction.
  2. 前記拡張部材の外表面および前記シャフトの外表面に配置されたチューブ部材を有し、
    前記線状部材は、前記チューブ部材の内腔に配置される、請求項1に記載の医療用長尺体。
    A tube member disposed on the outer surface of the expansion member and the outer surface of the shaft;
    The medical elongated body according to claim 1, wherein the linear member is disposed in a lumen of the tube member.
  3. 前記チューブ部材は、前記拡張部材の外表面に配置された第1領域と、前記第1領域の基端側に位置し、前記シャフトの外表面に配置された第2領域と、を有し、
    前記第1領域の内径は、前記拡張部材の拡張状態において、前記第2領域の内径よりも大きい、請求項2に記載の医療用長尺体。
    The tube member has a first region arranged on the outer surface of the expansion member, and a second region located on the proximal end side of the first region and arranged on the outer surface of the shaft,
    The medical elongated body according to claim 2, wherein an inner diameter of the first region is larger than an inner diameter of the second region in an expanded state of the expansion member.
  4. 前記変形領域は、自然状態で複数の前記凸部を形成するコイル部であり、
    前記線状部材は、前記拡張部材の収縮状態において、前記コイル部が軸方向に伸長された状態で、前記拡張部材の隣り合う前記羽根部の間に配置され、前記拡張部材の拡張状態において、前記拡張部材の外表面側で前記コイル部を形成する、請求項1〜3のいずれか1項に記載の医療用長尺体。
    The deformation region is a coil portion that forms the plurality of convex portions in a natural state,
    In the contracted state of the expansion member, the linear member is disposed between the blade portions adjacent to the expansion member, with the coil portion extended in the axial direction, and in the expanded state of the expansion member, The medical elongated body according to any one of claims 1 to 3, wherein the coil portion is formed on an outer surface side of the expansion member.
  5. 前記コイル部は、自然状態において、楕円形状または三角形状の前記凸部を形成する、請求項4に記載の医療用長尺体。   The said coil part is a medical elongate body of Claim 4 which forms the said elliptical shape or the triangular-shaped convex part in a natural state.
  6. 前記シャフトの基端部に配置されたハブと、
    前記線状部材に接続され、前記ハブに対して進退移動可能な操作部材と、を有する請求項1〜5のいずれか1項に記載の医療用長尺体。
    A hub disposed at the proximal end of the shaft;
    The medical elongated body according to any one of claims 1 to 5, further comprising an operation member connected to the linear member and capable of moving forward and backward with respect to the hub.
  7. 前記拡張部材は、前記拡張部材の収縮状態において、隣り合う前記羽根部同士を固定する仮固定部を有し、
    前記仮固定部による隣り合う前記羽根部同士の固定は、前記拡張部材の拡張状態において、解除される、請求項1〜6のいずれか1項に記載の医療用長尺体。
    The expansion member has a temporary fixing portion that fixes adjacent blade portions in the contracted state of the expansion member,
    The medical long body according to any one of claims 1 to 6, wherein fixing of the adjacent blade portions by the temporary fixing portion is released in an expanded state of the expansion member.
  8. 前記シャフトは、外管シャフトと、前記外管シャフトの内腔に配置された内管シャフトと、を有し、
    前記内管シャフトは、前記外管シャフトの途中で開口する基端開口部を有し、
    前記線状部材は、前記シャフトの軸心に垂直な断面において、前記シャフトの軸心に対して前記基端開口部と異なる位置に配置される、請求項1〜7のいずれか1項に記載の医療用長尺体。
    The shaft has an outer tube shaft, and an inner tube shaft disposed in a lumen of the outer tube shaft,
    The inner tube shaft has a proximal end opening that opens in the middle of the outer tube shaft,
    The said linear member is arrange | positioned in the position different from the said base end opening part with respect to the axial center of the said shaft in the cross section perpendicular | vertical to the axial center of the said shaft. Medical long body.
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Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH0330779A (en) * 1989-05-31 1991-02-08 Ashridge Ag Balloon catheter
JPH05506805A (en) * 1990-05-11 1993-10-07
JP2006512952A (en) * 2003-01-02 2006-04-20 ボストン サイエンティフィック リミテッド Medical instruments
US20080228139A1 (en) * 2007-02-06 2008-09-18 Cook Incorporated Angioplasty Balloon With Concealed Wires
JP2010179183A (en) * 2002-02-14 2010-08-19 Avantec Vascular Corp Balloon catheter for creating longitudinal axial channel in lesion and method therefor
JP2011098060A (en) * 2009-11-06 2011-05-19 Nipro Corp Cutting balloon catheter
JP2011245114A (en) * 2010-05-28 2011-12-08 Nipro Corp Balloon catheter
US20130190725A1 (en) * 2010-07-16 2013-07-25 Abbott Cardiovascular Systems Inc. Medical device having tissue engaging member and method for delivery of a therapeutic agent

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH0330779A (en) * 1989-05-31 1991-02-08 Ashridge Ag Balloon catheter
JPH05506805A (en) * 1990-05-11 1993-10-07
JP2010179183A (en) * 2002-02-14 2010-08-19 Avantec Vascular Corp Balloon catheter for creating longitudinal axial channel in lesion and method therefor
JP2006512952A (en) * 2003-01-02 2006-04-20 ボストン サイエンティフィック リミテッド Medical instruments
US20080228139A1 (en) * 2007-02-06 2008-09-18 Cook Incorporated Angioplasty Balloon With Concealed Wires
JP2011098060A (en) * 2009-11-06 2011-05-19 Nipro Corp Cutting balloon catheter
JP2011245114A (en) * 2010-05-28 2011-12-08 Nipro Corp Balloon catheter
US20130190725A1 (en) * 2010-07-16 2013-07-25 Abbott Cardiovascular Systems Inc. Medical device having tissue engaging member and method for delivery of a therapeutic agent

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