WO2018150772A1 - Suction catheter - Google Patents

Suction catheter Download PDF

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Publication number
WO2018150772A1
WO2018150772A1 PCT/JP2018/000679 JP2018000679W WO2018150772A1 WO 2018150772 A1 WO2018150772 A1 WO 2018150772A1 JP 2018000679 W JP2018000679 W JP 2018000679W WO 2018150772 A1 WO2018150772 A1 WO 2018150772A1
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WO
WIPO (PCT)
Prior art keywords
suction
tube
guide wire
catheter
blood vessel
Prior art date
Application number
PCT/JP2018/000679
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French (fr)
Japanese (ja)
Inventor
翠翠 李
Original Assignee
株式会社カネカ
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 株式会社カネカ filed Critical 株式会社カネカ
Priority to JP2018568043A priority Critical patent/JP7023875B2/en
Priority to CN201880011891.7A priority patent/CN110300611B/en
Publication of WO2018150772A1 publication Critical patent/WO2018150772A1/en

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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

Definitions

  • the present invention relates to a suction catheter.
  • a treatment method in which a thrombus is aspirated and removed is effective as a treatment method when a stenosis or occlusion occurs in a blood vessel such as a blood vessel, or when a blood vessel is occluded by a thrombus.
  • a catheter used for such treatment is called a suction catheter.
  • a suction catheter In treatment using a suction catheter, a guide wire is used to guide the suction catheter to the vicinity of the site to be suctioned in the blood vessel.
  • a suction catheter usually has a suction lumen having a suction port for sucking a suction target, and a guide wire lumen for inserting a guide wire. Therefore, when the surgeon inserts the suction catheter into the blood vessel and guides it to the target site for suction in the blood vessel, first, the operator inserts the guide wire into the blood vessel, and the distal end of the guide wire is the target site for suction. Hold in thrombus. Thereby, the route
  • the proximal side of the guide wire is passed through the distal end side of the guide wire lumen of the suction catheter, and the suction catheter is inserted into the blood vessel.
  • the suction catheter is moved in the blood vessel along the guide wire to reach the target site for suction, and the thrombus is sucked from the suction lumen. Therefore, the aspiration catheter is required to have reachability to a lesion site where a foreign object, which is a target to be suctioned, and suction performance for sucking as much of the target as possible.
  • Examples of conventional suction catheters include the suction catheters described in Patent Documents 1 and 2.
  • the suction catheter disclosed in Patent Document 1 has a configuration in which a suction port for sucking a suction target is formed to be inclined with respect to the axis of the suction lumen.
  • the suction catheter disclosed in Patent Document 2 has a configuration in which a distal end portion is curved.
  • the guide wire moves along the blood vessel wall, not the central portion of the blood vessel, and pierces the thrombus as the suction target site.
  • the distal end is retained by the thrombus.
  • the suction port of the suction catheter guided by the guide wire is often arranged close to the blood vessel wall and shifted from the center of the blood vessel. For this reason, when the suction operation is performed using the suction catheter, the thrombus in the vicinity of the suction port is satisfactorily sucked from the suction port.
  • An object of one embodiment of the present invention is to realize a suction catheter with improved suction performance of a suction target such as a thrombus.
  • a suction catheter is provided on the suction portion side of the first tube having a first lumen having a suction portion at a tip, and the first tube, A second tube having a second lumen through which the guide wire is inserted, wherein the suction part is a suction catheter having a suction port formed to be inclined with respect to an axis of the first tube, wherein the suction When the most distal end position in the section is the first position and the position farthest from the first position is the second position, at least the end portion on the suction port side of the second tube is curved toward the second position side It is characterized by having.
  • FIG. 6 is a front view showing a schematic configuration of the suction part of the suction tube as viewed from the distal end side along the long axis direction.
  • the aspiration catheter shows a state when it reaches a thrombus that is an object to be aspirated in the blood vessel
  • (a) is a cross-sectional view showing a schematic configuration when the aspiration catheter that is a premise of the embodiment of the present invention reaches the thrombus
  • (B) is a BB cross-sectional view of (a)
  • (c) is a cross-sectional view showing a schematic configuration when the suction catheter according to the embodiment of the present invention reaches a thrombus
  • (d ) Is a sectional view taken along the line CC of FIG.
  • the aspiration catheter which concerns on embodiment of this invention shows typically a mode that the blood vessel bent along a guide wire is moved
  • (a) is a case where the suction catheter contacts the blood vessel wall outside the bending part of the blood vessel. It is sectional drawing which shows a mode
  • (b) is a front view which shows the shape of the suction opening seen from the direction of the long axis in the state of (a)
  • (c) is a bent part of the blood vessel of the suction catheter It is sectional drawing which shows a mode in the case of contacting the blood vessel wall inside this
  • (d) is a front view which shows the shape of the suction opening seen from the direction of the long axis in the state of (c).
  • FIG. 1 shows a schematic configuration of an aspiration catheter 11 which is a premise of the present embodiment.
  • FIG. 1 (a) is a side view
  • FIG. 1 (b) is a sectional view.
  • the suction catheter 11 includes a suction tube 1 (first tube) constituting a suction lumen and a guide wire tube 2 (second tube) constituting a guide wire lumen.
  • a suction portion 3 is provided at the distal end of the suction tube 1.
  • the suction unit 3 has a suction port 3a for sucking a suction target such as a thrombus.
  • the suction port 3 a is provided to be inclined with respect to the axis of the suction tube 1.
  • the suction target side in the suction catheter is the distal end side or the distal side, and the opposite side is the proximal end side or the proximal side.
  • the guide wire tube 2 is provided on the suction part 3 side of the suction tube 1. Further, the distal end of the guide wire tube 2 is located on the distal side of the position 1 a on the most distal end side in the suction part 3. Moreover, the length of the guide wire tube 2 is 120 mm, for example.
  • the wall portion of the suction tube 1 has a laminated structure including an inner layer 12, a reinforcing layer 13, and a covering layer.
  • a fluorine-based resin or high-density polyethylene is used as the resin constituting the inner layer 12.
  • the resin constituting the inner layer 12 include polytetrafluoroethylene (PTFE), tetrafluoroethylene / perfluoroalkyl vinyl ether copolymer (PFA), tetrafluoroethylene / hexafluoropropylene copolymer (FEP), tetra Examples include fluoroethylene / ethylene copolymer (ETFE), polyvinylidene fluoride (PVDF), and polychlorotrifluoroethylene (PCTFE).
  • PTFE polytetrafluoroethylene
  • PFA perfluoroalkyl vinyl ether copolymer
  • FEP tetrafluoroethylene / hexafluoropropylene copolymer
  • ETDFE fluoroethylene / ethylene copolymer
  • PVDF polyvinylidene fluoride
  • PCTFE polychlorotrifluoroethylene
  • the reinforcing layer 13 has a braided shape in which strands are alternately knitted in a mesh shape.
  • Examples of the material of the strands of the reinforcing layer 13 include synthetic fibers such as nylon fibers, and metals such as Ti-Ni and stainless steel.
  • the covering layer 14 is a layer that covers the inner layer 12 and the braided reinforcing layer 13.
  • An elastomer is used as the resin constituting the coating layer 14.
  • Specific examples of the resin constituting the coating layer 15 include polyamide elastomer, polyester elastomer, polyolefin elastomer, and the like.
  • FIG. 2A is a diagram for explaining the relationship between the position 1a and the position 1b, and shows a schematic configuration of the suction part 3 of the suction tube 1 viewed from the distal end side along the long axis direction. It is a front view.
  • the suction tube 1 constitutes a suction lumen 1A (first lumen)
  • the guide wire tube 2 constitutes a guide wire lumen 2A (second lumen).
  • the tip position on the most distal end side in the suction port 3a of the suction unit 3 is defined as a position 1a (first position), and a position farthest from the position 1a is defined as a position 1b (second position).
  • the position 1a adjacent to the guide wire tube 2 is arranged at the most blood vessel wall side in the suction port 3a.
  • the position 1b is arranged at a position farthest from the blood vessel wall.
  • the position 1a is the upper side
  • the position 1b is arranged on the lower side. A portion between the position 1b and the position 1a is inclined upward from the position 1b toward the position 1a which is the tip position. If the position 1a is a nose, the position 1b can be regarded as a jaw.
  • the suction force at the position 1b in the suction port 3a is the largest. .
  • the position farthest from the position 1a will be described in more detail with reference to FIG.
  • the “position farthest from the position 1a” is considered based on the shape of the suction port 3a when the suction part 3 of the suction tube 1 is viewed from the distal end side as shown in FIG. That is, “the position farthest from the position 1a” means that a straight line connecting the position 1a and the arbitrary position P of the wall constituting the suction port 3a in the shape of the suction port 3a shown in FIG.
  • the position where the length D of the straight line is the longest. In the shape shown in FIG. 2B, the length Dm when the straight line connecting the position 1b and the position 1a is drawn is the longest.
  • the suction port 3 a is formed in the suction portion 3 of the suction tube 1 so as to be inclined with respect to the axis X.
  • the suction part 3 has a position 1a that is a position on the most distal end side and a position 1b that is a position on the most proximal end side. Therefore, it can be said that the positions 1a and 1b are the most distal end position and the most proximal end position of the suction part 3, respectively.
  • the suction catheter 10 has a curved portion 4 whose distal end is curved, as shown in FIG.
  • the bending portion 4 has a configuration in which at least the end portion on the suction portion 3 side (that is, the distal side) is bent toward the position 1b side.
  • the shape of the side wall constituting the suction port 3a (hereinafter simply referred to as the shape of the suction port 3a) is a substantially perfect circle shape. .
  • the bending portion 4 is configured to be curved so as to intersect the axis X of the suction tube 1.
  • the intersection point 4a is arranged at least on the distal end side from the position 1b.
  • the angle formed between the straight line connecting the position 1a and the position 1b and the axis X is preferably 5 degrees to 45 degrees, and more preferably 7 degrees to 30 degrees. .
  • the suction catheter 10 shown in FIG. 2A has a natural configuration in which the guide wire is not inserted into the guide wire tube 2.
  • the suction catheter 10 having the curved portion 4 in such a natural state has a shape that follows the shape of the guide wire that moves along the blood vessel wall when the guide wire is inserted into the guide wire tube 2.
  • FIG. 3 shows a state when the suction catheter reaches a thrombus as a suction target in the blood vessel.
  • FIG. 3A is a cross-sectional view showing a schematic configuration when the suction catheter 11 which is a premise of the present embodiment reaches a thrombus.
  • FIG. 4 is a cross-sectional view taken along the line BB of FIG. 3A of FIG.
  • FIG. 3C is a cross-sectional view showing a schematic configuration when the suction catheter 10 according to the present embodiment reaches a thrombus.
  • FIG. 3D is a cross-sectional view taken along the line CC of FIG.
  • the guide wire 5 moves along the blood vessel wall in the blood vessel 6. Then, when the distal end of the guide wire 5 is hooked on the thrombus 6A, which is a site to be aspirated, a route by the guide wire 5 for the suction catheter 10 or 11 to reach the thrombus 6A is secured.
  • the suction catheter 10 or 11 is inserted into the blood vessel along the guide wire 5 by passing the guide wire 5 through the guide wire lumen.
  • the blood vessel wall on the side close to the guide wire tube 2 is the upper blood vessel wall 6c
  • the blood vessel wall on the opposite side is the lower blood vessel wall 6b.
  • the distal end portion of the guide wire 5 (for example, a portion of about 15 cm from the distal end to the proximal end side) is more flexible than the proximal end portion so that the blood vessel is not damaged.
  • the guide wire 5 becomes more flexible as it goes toward the distal end.
  • the guide wire tube 2 follows the shape of the guide wire 5 passing through the guide wire tube 2. Further, when the suction catheter 10 or 11 moves along the distal end portion of the guide wire 5, the guide wire 5 is flexible, so that the followability of the shape of the guide wire tube 2 with respect to the guide wire 5 is far away. It becomes smaller as it goes to the end. For example, a portion of 3 cm from the distal end of the guide wire 5 has flexibility such that the shape of the guide wire 5 follows the shape of the guide wire tube 2.
  • the suction tube 1 moves along the guide wire 5 and reaches the thrombus 6A. 1b is positioned from the lower vessel wall 6b at a distance D 2 apart level P 2.
  • the portion of the guide wire 5 on the distal end side near the thrombus 6A is flexible, the followability of the shape of the guide wire tube 2 with respect to the guide wire 5 becomes smaller toward the distal end. Since the suction catheter 10 has the bending portion 4 at least in the guide wire tube 2, the state in which the action of the guide wire 5 following the shape of the bending portion 4 and the action of the bending portion 4 following the shape of the guide wire 5 are antagonized.
  • the distance D 2 between the position 1b and the lower blood vessel wall 6b in aspiration catheter 10 is smaller than the distance D 1 of the the position 1b and the lower blood vessel wall 6b in the suction catheter 11. For this reason, according to the suction catheter 10 according to the present embodiment, the performance of sucking the thrombus 6A attached to the lower blood vessel wall 6b is improved.
  • the thrombus 6A contains a fibrous material. For this reason, when the suction force with respect to the thrombus 6A attached to the lower blood vessel wall 6b is insufficient, the relatively large thrombus 6A is sucked from the suction port 3a while being dragged by the fiber. Therefore, the suction tube 1 may be blocked by the large thrombus 6A. In contrast, in the aspiration catheter 10, the suction force it is possible to reduce the distance D 2 between the highest position 1b and the lower vessel wall 6b, sufficient to finely divided thrombus 6A including fibrous A suction force can be realized. Therefore, the suction tube 1 can be prevented from being blocked by the thrombus 6A.
  • the bending portion 4 may be bent at least at a position where the guide wire tube 2 is bent.
  • the bending allowable portion Z of the bending portion 4 is from the tip of the guide wire tube 2 to the position c of the guide wire tube 2 from the position 1 b ′ to the opposite side of the position 1 a, that is, to the position c of 5 mm at the maximum.
  • the portion may be curved.
  • the position c is preferably a position of a maximum of 2 mm from the position 1b 'to the hand side.
  • the position 1 b ′ of the guide wire tube 2 is a point where a line that passes through the position 1 b and is perpendicular to the axis X of the suction tube 1 intersects the guide wire tube 2 in FIG.
  • FIG. 4 is a diagram schematically showing how the suction catheter 10 moves along the blood vessel 6 bent along the guide wire 5.
  • 4A is a cross-sectional view showing a state where the suction catheter 10 contacts the blood vessel wall 6d outside the bent portion of the blood vessel 6.
  • FIG. 4B is a diagram illustrating the shape of the suction port 3a in the state of FIG.
  • FIG. 4C is a cross-sectional view showing a state where the suction catheter 10 contacts the blood vessel wall 6e inside the bent portion of the blood vessel 6.
  • FIG. 4B is a diagram illustrating the shape of the suction port 3a in the state of FIG.
  • the bending portion 4 is positioned so as to be separated from the axis X of the suction tube 1. It curves to the position 1a side opposite to 1b.
  • the shape of the suction port 3a extends in the vertical direction as shown in FIG. 4D, and changes from a perfect circle shape to a vertical ellipse shape.
  • the position 1b portion (jaw) of the suction catheter 10 extends toward the position 1a. For this reason, it is possible to suppress the catch between the position 1b portion (jaw portion) and the blood vessel wall 6d outside the bent portion of the blood vessel 6.
  • the manufacturing method of the suction catheter 10 according to the present embodiment is not particularly limited as long as it includes a bending step of bending at least the end portion of the guide wire tube 2 on the suction port 3a side toward the position 1b.
  • the suction tube 1 and the guide wire tube 2 are welded by a conventionally known manufacturing method to manufacture the suction catheter 11 shown in FIG. 3A, and the suction catheter 11 is bent. Is mentioned.
  • a method for bending the suction catheter 11 for example, first, a bent metal core material is inserted into the guide wire tube 2 of the suction catheter 11. Thereafter, heat processing and cooling are performed below the melting points of the suction tube 1 and the guide wire tube 2. Finally, by pulling out the metal core material from the guide wire tube 2, the suction catheter 10 in which the curved portion 4 is formed is obtained.
  • a guide wire tube 2 having a curved portion 4 and a suction tube 1 that is curved along the curved portion 4 are prepared in advance, and both the tubes are welded by a conventionally known method. It is done.
  • a suction catheter 10 includes a suction tube 1 as a first tube provided with a suction lumen 1A as a first lumen having a suction portion 3 at a distal end, and a suction portion 3 side of the suction tube 1.
  • a guide wire tube 2 as a second tube having a guide wire lumen 2A as a second lumen through which the guide wire 5 is inserted, and the suction part 3 is inclined with respect to the axis X of the suction tube 1
  • the most distal position in the suction part 3 is defined as position 1a (first position), and the position farthest from the first position is defined as position 1b (second position).
  • the guide wire tube 2 includes a curved portion 4 that is curved toward the position 1b at least at the end on the suction port 3a side.
  • the bending portion 4 has a configuration in which the position 1a as the farthest near end position in the suction portion 3 is curved toward the position 1b as the nearest end position.
  • the end of the guide wire tube 2 on the suction port 3a side is provided with the curved portion 4 curved toward the position 1b, so that the suction tube 1 moves along the guide wire 5 and becomes a thrombus.
  • the position reaches the position 1b having the highest suction force in the suction catheter 10 approaches the lower blood vessel wall, and the distance between the position 1b and the lower blood vessel wall decreases.
  • the thrombus adhering to the lower blood vessel wall can be attracted
  • the curved portion 4 intersects the axis X of the suction tube 1 as the first tube.
  • the suction tube 1 moves along the guide wire 5 and reaches the thrombus, the position 1b in the suction catheter 10 can be brought closer to the lower blood vessel wall.
  • the suction tube 1 as the first tube and the guide wire tube 2 as the second tube are arranged such that their axes X and Y are parallel over the entire length.
  • the curved portion 4 is preferably formed with a recess 2a that is recessed toward the position 1b (second position).
  • the recessed part 2a hollowed in the position 1b (2nd position) side is formed in the curved part 4.
  • the position 1b of the suction catheter 10 is shifted downward by the recess 2a. Therefore, according to the above configuration, when the suction tube 1 moves along the guide wire 5 and reaches the thrombus, the position 1b in the suction catheter 10 can be brought closer to the lower blood vessel wall more reliably.
  • the guide wire tube 2 as the second tube has a position 1b (in the suction portion 3 of the suction tube 1 as the first tube from the tip thereof.
  • a portion from the second position) to the position opposite to the position 1a (first position) up to a position of 2 mm may be curved.
  • the manufacturing method of the suction catheter 10 includes a suction tube 1 as a first tube having a suction lumen 1A as a first lumen having a suction portion 3 at the tip, and a suction portion of the suction tube 1 3, and a guide wire tube 2 as a second tube having a guide wire lumen 2 ⁇ / b> A as a second lumen through which the guide wire 5 is inserted, and the suction unit 3 is arranged with respect to the axis X of the suction tube 1.
  • the distal end position in the suction part 3 is defined as a position 1a (first position), and the position farthest from the first position is defined as a position 1b. (Second position), characterized in that it includes a bending step of bending at least the end of the guide wire tube 2 on the suction port 3a side toward the position 1b. To have.
  • the suction catheter 10 with improved suction performance can be manufactured.
  • Suction tube 1A Suction lumen (first lumen) 1a position (first position) 1b position (second position) 2 Guide wire tube (second tube) 2A Guide wire lumen (second lumen) 2a Concave part 3 Suction part 3a Suction port 4 Bending part 5 Guide wire 6 Blood vessel 6A Thrombus 10 Suction catheter

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Abstract

The purpose of the present invention is to realize a suction catheter having an improved ability to suck objects to be sucked (e.g., blood clots). This suction catheter (10) is provided with a curved section (4) at which at least an end part on a suction opening (3a) side of a guide wire tube (2) is curved towards a second position (1b) side.

Description

吸引カテーテルAspiration catheter
　本発明は吸引カテーテルに関する。 The present invention relates to a suction catheter.
　従来、血管などの脈管において狭窄あるいは閉塞が生じた場合、及び血栓により血管が閉塞してしまった場合の治療方法として、血栓を吸引して除去する治療法が有効である。このような治療法に使用するカテーテルは吸引カテーテルと呼ばれている。 Conventionally, a treatment method in which a thrombus is aspirated and removed is effective as a treatment method when a stenosis or occlusion occurs in a blood vessel such as a blood vessel, or when a blood vessel is occluded by a thrombus. A catheter used for such treatment is called a suction catheter.
　吸引カテーテルを用いた治療では、吸引カテーテルを血管内の吸引対象部位近傍まで導くためにガイドワイヤを用いる。吸引カテーテルは、通常、吸引対象を吸引する吸引口を有する吸引ルーメンと、ガイドワイヤを挿入するためのガイドワイヤルーメンと、を有する。それゆえ、術者は、吸引カテーテルを血管内に挿入し血管内の吸引対象部位まで導くに際し、まず、ガイドワイヤを血管内に挿通し、ガイドワイヤの遠位側端部を吸引対象部位である血栓に保持させる。これにより、吸引カテーテルが吸引対象部位へ到達するためのガイドワイヤによる経路を確保する。その後、ガイドワイヤの手元側を吸引カテーテルのガイドワイヤルーメンの先端側に通して、吸引カテーテルを血管に挿入させる。ガイドワイヤに沿って吸引カテーテルを血管内で移動させることにより吸引対象部位に到達させ、吸引ルーメンから血栓を吸引する。それゆえ、吸引カテーテルには、吸引する対象である異物が存在する病変部位への到達性と、対象物をできる限り多く吸引するための吸引性能とが同時に求められる。 In treatment using a suction catheter, a guide wire is used to guide the suction catheter to the vicinity of the site to be suctioned in the blood vessel. A suction catheter usually has a suction lumen having a suction port for sucking a suction target, and a guide wire lumen for inserting a guide wire. Therefore, when the surgeon inserts the suction catheter into the blood vessel and guides it to the target site for suction in the blood vessel, first, the operator inserts the guide wire into the blood vessel, and the distal end of the guide wire is the target site for suction. Hold in thrombus. Thereby, the route | root by a guide wire for the suction catheter to reach | attain a site | part to be aspirated is ensured. Thereafter, the proximal side of the guide wire is passed through the distal end side of the guide wire lumen of the suction catheter, and the suction catheter is inserted into the blood vessel. The suction catheter is moved in the blood vessel along the guide wire to reach the target site for suction, and the thrombus is sucked from the suction lumen. Therefore, the aspiration catheter is required to have reachability to a lesion site where a foreign object, which is a target to be suctioned, and suction performance for sucking as much of the target as possible.
　従来の吸引カテーテルとして、例えば特許文献１及び２に記載された吸引カテーテルが挙げられる。 Examples of conventional suction catheters include the suction catheters described in Patent Documents 1 and 2.
　特許文献１に開示された吸引カテーテルは、吸引対象を吸引する吸引口が吸引ルーメンの軸線に対して傾斜して形成された構成となっている。また、特許文献２に開示された吸引カテーテルは、末端側端部が湾曲した構成となっている。 The suction catheter disclosed in Patent Document 1 has a configuration in which a suction port for sucking a suction target is formed to be inclined with respect to the axis of the suction lumen. Moreover, the suction catheter disclosed in Patent Document 2 has a configuration in which a distal end portion is curved.
特開2013-31522号公報JP 2013-31522 国際公開2007/022383号パンフレットInternational publication 2007/022383 pamphlet
　ここで、吸引カテーテルを血管内に挿入し血管内の吸引対象部位まで導くに際し、ガイドワイヤは、血管の中心部分ではなく、血管壁に沿って移動し、吸引対象部位である血栓に突き刺さることで遠位側端部が血栓に保持される。ガイドワイヤにより導かれた吸引カテーテルの吸引口は、血管壁に近接し、血管の中心からずれた配置となることが多い。このため、吸引カテーテルを用いて吸引動作をしたとき、吸引口近傍の血栓は吸引口から良好に吸引される。しかし、吸引カテーテルにおいてガイドワイヤルーメンと吸引ルーメンとは、平行に配置されているため、例えば吸引口から離れたガイドワイヤ付近の血管壁に存在する血栓は、十分に吸引されない。それゆえ、従来の吸引カテーテルでは、血栓を十分に吸引することができないという問題がある。 Here, when the suction catheter is inserted into the blood vessel and guided to the suction target site in the blood vessel, the guide wire moves along the blood vessel wall, not the central portion of the blood vessel, and pierces the thrombus as the suction target site. The distal end is retained by the thrombus. The suction port of the suction catheter guided by the guide wire is often arranged close to the blood vessel wall and shifted from the center of the blood vessel. For this reason, when the suction operation is performed using the suction catheter, the thrombus in the vicinity of the suction port is satisfactorily sucked from the suction port. However, since the guide wire lumen and the suction lumen are arranged in parallel in the suction catheter, for example, a thrombus present on the blood vessel wall near the guide wire away from the suction port is not sufficiently sucked. Therefore, there is a problem that the conventional suction catheter cannot sufficiently suck the thrombus.
　本発明の一態様は、血栓などの吸引対象物の吸引性能が向上した吸引カテーテルを実現することを目的とする。 An object of one embodiment of the present invention is to realize a suction catheter with improved suction performance of a suction target such as a thrombus.
　上記の課題を解決するために、本発明の一態様に係る吸引カテーテルは、先端に吸引部を有する第１ルーメンを備えた第１チューブと、前記第１チューブの前記吸引部側に設けられ、ガイドワイヤが挿通する第２ルーメンを有する第２チューブと、を備え、前記吸引部は、前記第１チューブの軸線に対して傾斜して形成された吸引口を有する吸引カテーテルであって、前記吸引部における最も先端位置を第１位置とし、該第１位置から最も遠い位置を第２位置とすると、少なくとも前記第２チューブにおける前記吸引口側の端部が前記第２位置側へ湾曲した湾曲部を備えていることを特徴としている。 In order to solve the above-described problem, a suction catheter according to an aspect of the present invention is provided on the suction portion side of the first tube having a first lumen having a suction portion at a tip, and the first tube, A second tube having a second lumen through which the guide wire is inserted, wherein the suction part is a suction catheter having a suction port formed to be inclined with respect to an axis of the first tube, wherein the suction When the most distal end position in the section is the first position and the position farthest from the first position is the second position, at least the end portion on the suction port side of the second tube is curved toward the second position side It is characterized by having.
　本発明の一態様によれば、血栓などの吸引対象物の吸引性能が向上するという効果を奏する。 According to one aspect of the present invention, there is an effect that the suction performance of a suction target such as a thrombus is improved.
本発明の実施形態の前提となる吸引カテーテルの概略構成を示し、（ａ）は、側面図であり、（ｂ）はＡ－Ａ線断面図である。BRIEF DESCRIPTION OF THE DRAWINGS The schematic structure of the suction catheter used as the premise of embodiment of this invention is shown, (a) is a side view, (b) is an AA sectional view. （ａ）は、本発明の実施形態に係る吸引カテーテルの遠位端側の概略構成を示す断面図であり、（ｂ）は、第１の位置と第２の位置との関係を説明するための図であり、吸引チューブの吸引部を長軸方向に沿って遠位端側から見た概略構成を示す正面図である。(A) is sectional drawing which shows schematic structure of the distal end side of the suction catheter which concerns on embodiment of this invention, (b) is for demonstrating the relationship between a 1st position and a 2nd position. FIG. 6 is a front view showing a schematic configuration of the suction part of the suction tube as viewed from the distal end side along the long axis direction. 吸引カテーテルが血管中にて吸引対象物である血栓に到達したときの状態を示し、（ａ）は本発明の実施形態の前提となる吸引カテーテルが血栓に到達した場合の概略構成を示す断面図であり、（ｂ）の（ａ）のＢ－Ｂ断面図であり、（ｃ）は本発明の実施形態に係る吸引カテーテルが血栓に到達した場合の概略構成を示す断面図であり、（ｄ）は（ｃ）のＣ－Ｃ断面図である。The aspiration catheter shows a state when it reaches a thrombus that is an object to be aspirated in the blood vessel, and (a) is a cross-sectional view showing a schematic configuration when the aspiration catheter that is a premise of the embodiment of the present invention reaches the thrombus (B) is a BB cross-sectional view of (a), (c) is a cross-sectional view showing a schematic configuration when the suction catheter according to the embodiment of the present invention reaches a thrombus, (d ) Is a sectional view taken along the line CC of FIG. 本発明の実施形態に係る吸引カテーテルがガイドワイヤに沿って屈曲する血管を移動する様子を模式的に示し、（ａ）は、吸引カテーテルが血管の屈曲部分の外側の血管壁に接触する場合の様子を示す断面図であり、（ｂ）は、（ａ）の状態での長軸の方向から見た吸引口の形状を示す正面図であり、（ｃ）は、吸引カテーテルが血管の屈曲部分の内側の血管壁に接触する場合の様子を示す断面図であり、（ｄ）は、（ｃ）の状態での長軸の方向から見た吸引口の形状を示す正面図である。The aspiration catheter which concerns on embodiment of this invention shows typically a mode that the blood vessel bent along a guide wire is moved, (a) is a case where the suction catheter contacts the blood vessel wall outside the bending part of the blood vessel. It is sectional drawing which shows a mode, (b) is a front view which shows the shape of the suction opening seen from the direction of the long axis in the state of (a), (c) is a bent part of the blood vessel of the suction catheter It is sectional drawing which shows a mode in the case of contacting the blood vessel wall inside this, (d) is a front view which shows the shape of the suction opening seen from the direction of the long axis in the state of (c).
　以下、本発明の実施の形態について、詳細に説明する。 Hereinafter, embodiments of the present invention will be described in detail.
　（本実施形態の前提となる吸引カテーテルの構成）
　まず、本実施形態の前提となる吸引カテーテルの構成について、説明する。図１は、本実施形態の前提となる吸引カテーテル１１の概略構成を示し、図１の（ａ）は、側面図であり、図１の（ｂ）は断面図である。 (Configuration of suction catheter as a premise of the present embodiment)
First, the configuration of the suction catheter that is a premise of the present embodiment will be described. FIG. 1 shows a schematic configuration of an aspiration catheter 11 which is a premise of the present embodiment. FIG. 1 (a) is a side view, and FIG. 1 (b) is a sectional view.
　図１の（ａ）に示されるように、吸引カテーテル１１は、吸引ルーメンを構成する吸引チューブ１（第１チューブ）と、ガイドワイヤルーメンを構成するガイドワイヤチューブ２（第２チューブ）と、を備えている。吸引チューブ１の遠位端には、吸引部３が設けられている。この吸引部３は、血栓などの吸引対象を吸引するための吸引口３ａを有する。吸引口３ａは、吸引チューブ１の軸線に対して傾斜して設けられている。ここで、吸引カテーテルにおける吸引対象側を遠位端側、または遠位側とし、それと反対側を近位端側、または近位側とする。 As shown in FIG. 1A, the suction catheter 11 includes a suction tube 1 (first tube) constituting a suction lumen and a guide wire tube 2 (second tube) constituting a guide wire lumen. I have. A suction portion 3 is provided at the distal end of the suction tube 1. The suction unit 3 has a suction port 3a for sucking a suction target such as a thrombus. The suction port 3 a is provided to be inclined with respect to the axis of the suction tube 1. Here, the suction target side in the suction catheter is the distal end side or the distal side, and the opposite side is the proximal end side or the proximal side.
　ガイドワイヤチューブ２は、吸引チューブ１の吸引部３側に設けられている。また、ガイドワイヤチューブ２の遠位端は、吸引部３における最も遠位端側の位置１ａよりも遠位側に位置している。また、ガイドワイヤチューブ２の長さは、例えば、１２０ｍｍである。 The guide wire tube 2 is provided on the suction part 3 side of the suction tube 1. Further, the distal end of the guide wire tube 2 is located on the distal side of the position 1 a on the most distal end side in the suction part 3. Moreover, the length of the guide wire tube 2 is 120 mm, for example.
　また、図１の（ｂ）に示されるように、吸引チューブ１の壁部は、内層１２、補強層１３、及び被覆層１４を備えた積層構造である。内層１２を構成する樹脂は、フッ素系樹脂や高密度ポリエチレンが用いられる。内層１２を構成する樹脂の具体例としては、ポリテトラフルオロエチレン（ＰＴＦＥ）、テトラフルオロエチレン・パーフルオロアルキルビニルエーテル共重合体（ＰＦＡ）、テトラフルオロエチレン・ヘキサフルオロプロピレン共重合体（ＦＥＰ）、テトラフルオロエチレン・エチレン共重合体（ＥＴＦＥ）、ポリビニリデンフルオライド（ＰＶＤＦ）、ポリクロロトリフルオロエチレン（ＰＣＴＦＥ）等が挙げられる。 Further, as shown in FIG. 1B, the wall portion of the suction tube 1 has a laminated structure including an inner layer 12, a reinforcing layer 13, and a covering layer. As the resin constituting the inner layer 12, a fluorine-based resin or high-density polyethylene is used. Specific examples of the resin constituting the inner layer 12 include polytetrafluoroethylene (PTFE), tetrafluoroethylene / perfluoroalkyl vinyl ether copolymer (PFA), tetrafluoroethylene / hexafluoropropylene copolymer (FEP), tetra Examples include fluoroethylene / ethylene copolymer (ETFE), polyvinylidene fluoride (PVDF), and polychlorotrifluoroethylene (PCTFE).
　また、補強層１３は、素線を交互に網目状に編んだ編組形状となっている。補強層１３の素線の材質としては、例えばナイロン繊維等の合成繊維や、Ti-Ni、ステンレス鋼等の金属が挙げられる。 Further, the reinforcing layer 13 has a braided shape in which strands are alternately knitted in a mesh shape. Examples of the material of the strands of the reinforcing layer 13 include synthetic fibers such as nylon fibers, and metals such as Ti-Ni and stainless steel.
　被覆層１４は、内層１２及び編組形状の補強層１３を被覆する層である。被覆層１４を構成する樹脂は、エラストマーが用いられる。被覆層１５を構成する樹脂の具体例としては、ポリアミドエラストマー、ポリエステルエラストマー、ポリオレフィンエラストマー等が挙げられる。 The covering layer 14 is a layer that covers the inner layer 12 and the braided reinforcing layer 13. An elastomer is used as the resin constituting the coating layer 14. Specific examples of the resin constituting the coating layer 15 include polyamide elastomer, polyester elastomer, polyolefin elastomer, and the like.
　（本実施形態に係る吸引カテーテルの構成）
　本実施形態に係る吸引カテーテルは、図１に示された吸引カテーテル１１における遠位端側の構造に特徴がある。図２の（ａ）は、本実施形態に係る吸引カテーテル１０の遠位端側の概略構成を示す断面図である。図２の（ｂ）は、位置１ａと位置１ｂとの関係を説明するための図であり、吸引チューブ１の吸引部３を長軸方向に沿って遠位端側から見た概略構成を示す正面図である。図２の（ａ）に示す構成において、吸引チューブ１は、吸引ルーメン１Ａ（第１ルーメン）を構成し、ガイドワイヤチューブ２は、ガイドワイヤルーメン２Ａ（第２ルーメン）を構成する。 (Configuration of suction catheter according to this embodiment)
The suction catheter according to this embodiment is characterized by the structure of the distal end side of the suction catheter 11 shown in FIG. (A) of FIG. 2 is sectional drawing which shows schematic structure of the distal end side of the suction catheter 10 which concerns on this embodiment. FIG. 2B is a diagram for explaining the relationship between the position 1a and the position 1b, and shows a schematic configuration of the suction part 3 of the suction tube 1 viewed from the distal end side along the long axis direction. It is a front view. In the configuration shown in FIG. 2A, the suction tube 1 constitutes a suction lumen 1A (first lumen), and the guide wire tube 2 constitutes a guide wire lumen 2A (second lumen).
　吸引カテーテル１０において、吸引部３の吸引口３ａにおける最も遠位端側の先端位置を位置１ａ（第１の位置）とし、位置１ａから最も遠い位置を位置１ｂ（第２の位置）とする。なお、血管内で、ガイドワイヤはよく血管壁に沿って配置されるため、ガイドワイヤチューブ２に隣接する位置１ａは、吸引口３ａにおいて最も血管壁側に配される。一方、位置１ｂは、血管壁から最も遠い位置に配される。位置１ａを上側とした場合、位置１ｂは下側に配される。そして、位置１ｂと位置１ａの間の部分は、位置１ｂから先端位置である位置１ａへ向けて上方へ傾斜した形状になっている。位置１ａの部分を鼻部とすると、位置１ｂは顎部と捉えることができる。 In the suction catheter 10, the tip position on the most distal end side in the suction port 3a of the suction unit 3 is defined as a position 1a (first position), and a position farthest from the position 1a is defined as a position 1b (second position). In the blood vessel, since the guide wire is often arranged along the blood vessel wall, the position 1a adjacent to the guide wire tube 2 is arranged at the most blood vessel wall side in the suction port 3a. On the other hand, the position 1b is arranged at a position farthest from the blood vessel wall. When the position 1a is the upper side, the position 1b is arranged on the lower side. A portion between the position 1b and the position 1a is inclined upward from the position 1b toward the position 1a which is the tip position. If the position 1a is a nose, the position 1b can be regarded as a jaw.
　図２の（ａ）に示されるような、吸引チューブ１の軸線Ｘに対して傾斜して吸引口３ａが設けられた吸引カテーテル１０では、吸引口３ａにおける位置１ｂでの吸引力が最も大きくなる。 In the suction catheter 10 provided with the suction port 3a inclined with respect to the axis X of the suction tube 1 as shown in FIG. 2A, the suction force at the position 1b in the suction port 3a is the largest. .
　ここで、「位置１ａから最も遠い位置」について、図２の（ｂ）を参照して、さらに詳述する。「位置１ａから最も遠い位置」は、図２の（ｂ）のように吸引チューブ１の吸引部３を遠位端側から見たときの吸引口３ａの形状を基準に考える。すなわち、「位置１ａから最も遠い位置」とは、図２の（ｂ）に示す吸引口３ａの形状において吸引口３ａを構成する壁の任意の位置Ｐと位置１ａとを結ぶ直線を引いたとき、当該直線の長さＤが最も長くなる位置のことをいう。図２の（ｂ）に示す形状では、位置１ｂと位置１ａとを結ぶ直線を引いたときの長さＤｍが最も長くなる。 Here, “the position farthest from the position 1a” will be described in more detail with reference to FIG. The “position farthest from the position 1a” is considered based on the shape of the suction port 3a when the suction part 3 of the suction tube 1 is viewed from the distal end side as shown in FIG. That is, “the position farthest from the position 1a” means that a straight line connecting the position 1a and the arbitrary position P of the wall constituting the suction port 3a in the shape of the suction port 3a shown in FIG. The position where the length D of the straight line is the longest. In the shape shown in FIG. 2B, the length Dm when the straight line connecting the position 1b and the position 1a is drawn is the longest.
　このように吸引カテーテル１０では、吸引チューブ１の吸引部３に、軸線Ｘに対して傾斜して吸引口３ａが形成されている。このため、吸引部３には、最も遠位端側の位置である位置１ａ、及び最も近位端側の位置である位置１ｂが存在する。それゆえ、位置１ａ及び１ｂはそれぞれ、吸引部３の最遠位端位置及び最近位端位置であるともいえる。 Thus, in the suction catheter 10, the suction port 3 a is formed in the suction portion 3 of the suction tube 1 so as to be inclined with respect to the axis X. For this reason, the suction part 3 has a position 1a that is a position on the most distal end side and a position 1b that is a position on the most proximal end side. Therefore, it can be said that the positions 1a and 1b are the most distal end position and the most proximal end position of the suction part 3, respectively.
　本実施形態に係る吸引カテーテル１０は、図２の（ａ）に示されるように、遠位端が湾曲した湾曲部４を有している。湾曲部４は、少なくとも吸引部３側（すなわち遠位側）の端部が位置１ｂ側へ湾曲した構成となっている。また、図２の（ｂ）に示されるように、湾曲部４において、吸引口３ａを構成する側壁の形状（以下、単に吸引口３ａの形状と称する）は、略真円形状となっている。 The suction catheter 10 according to the present embodiment has a curved portion 4 whose distal end is curved, as shown in FIG. The bending portion 4 has a configuration in which at least the end portion on the suction portion 3 side (that is, the distal side) is bent toward the position 1b side. Further, as shown in FIG. 2B, in the bending portion 4, the shape of the side wall constituting the suction port 3a (hereinafter simply referred to as the shape of the suction port 3a) is a substantially perfect circle shape. .
　また、湾曲部４は、吸引チューブ１の軸線Ｘと交差しているように湾曲した構成となっている。換言すれば、吸引チューブ１の軸線Ｘと湾曲部４とが交差する交点を交点４ａとしたとき、交点４ａが少なくとも位置１ｂよりも遠位端側に配される構成である。 Further, the bending portion 4 is configured to be curved so as to intersect the axis X of the suction tube 1. In other words, when the intersection point between the axis X of the suction tube 1 and the bending portion 4 is defined as the intersection point 4a, the intersection point 4a is arranged at least on the distal end side from the position 1b.
　湾曲部４は、図２（ａ）において、位置１ａおよび位置１ｂを結ぶ直線と軸線Ｘとのなす角度が５度から４５度であることが好ましく、さらに好ましくは、７度から３０度である。 2A, the angle formed between the straight line connecting the position 1a and the position 1b and the axis X is preferably 5 degrees to 45 degrees, and more preferably 7 degrees to 30 degrees. .
　ここで、図２の（ａ）に示された吸引カテーテル１０は、ガイドワイヤチューブ２にガイドワイヤが挿入されていない自然状態での構成である。このような自然状態で湾曲部４を有する吸引カテーテル１０は、ガイドワイヤチューブ２にガイドワイヤが挿入された状態では、血管壁につたって移動するガイドワイヤの形状に追随した形状となる。 Here, the suction catheter 10 shown in FIG. 2A has a natural configuration in which the guide wire is not inserted into the guide wire tube 2. The suction catheter 10 having the curved portion 4 in such a natural state has a shape that follows the shape of the guide wire that moves along the blood vessel wall when the guide wire is inserted into the guide wire tube 2.
　図３は、吸引カテーテルが血管中にて吸引対象物である血栓に到達したときの状態を示す。図３の（ａ）は本実施形態の前提となる吸引カテーテル１１が血栓に到達した場合の概略構成を示す断面図である。図３の（ｂ）の図３の（ａ）のＢ－Ｂ断面図である。図３の（ｃ）は本実施形態に係る吸引カテーテル１０が血栓に到達した場合の概略構成を示す断面図である。図３の（ｄ）は図３の（ｃ）のＣ－Ｃ断面図である。 FIG. 3 shows a state when the suction catheter reaches a thrombus as a suction target in the blood vessel. FIG. 3A is a cross-sectional view showing a schematic configuration when the suction catheter 11 which is a premise of the present embodiment reaches a thrombus. FIG. 4 is a cross-sectional view taken along the line BB of FIG. 3A of FIG. FIG. 3C is a cross-sectional view showing a schematic configuration when the suction catheter 10 according to the present embodiment reaches a thrombus. FIG. 3D is a cross-sectional view taken along the line CC of FIG.
　図３の（ａ）または（ｂ）に示されるように、吸引カテーテル１０または１１を用いた治療においては、まず、血管６内にて、ガイドワイヤ５が血管壁に沿って移動する。そして、ガイドワイヤ５の遠位側端部が吸引対象部位である血栓６Ａに引っ掛かることにより、吸引カテーテル１０または１１が血栓６Ａへ到達するためのガイドワイヤ５による経路が確保される。吸引カテーテル１０または１１は、ガイドワイヤ５をガイドワイヤルーメンに通し、ガイドワイヤ５に沿って血管内に挿入される。ここで、図３の（ａ）～（ｄ）において、ガイドワイヤチューブ２に近接する側の血管壁を上側血管壁６ｃとし、その反対側の血管壁を下側血管壁６ｂとする。 3 (a) or 3 (b), in the treatment using the suction catheter 10 or 11, first, the guide wire 5 moves along the blood vessel wall in the blood vessel 6. Then, when the distal end of the guide wire 5 is hooked on the thrombus 6A, which is a site to be aspirated, a route by the guide wire 5 for the suction catheter 10 or 11 to reach the thrombus 6A is secured. The suction catheter 10 or 11 is inserted into the blood vessel along the guide wire 5 by passing the guide wire 5 through the guide wire lumen. Here, in FIGS. 3A to 3D, the blood vessel wall on the side close to the guide wire tube 2 is the upper blood vessel wall 6c, and the blood vessel wall on the opposite side is the lower blood vessel wall 6b.
　ガイドワイヤ５の遠位端側の部分（例えば遠位端から近位端側へ１５ｃｍ程度の部分）は、血管が傷つかないように、近位端側の部分よりも柔軟になっている。そして、ガイドワイヤ５は、遠位端へ向かうに従い、柔軟性が高くなる。 The distal end portion of the guide wire 5 (for example, a portion of about 15 cm from the distal end to the proximal end side) is more flexible than the proximal end portion so that the blood vessel is not damaged. The guide wire 5 becomes more flexible as it goes toward the distal end.
　吸引カテーテル１０または１１がガイドワイヤ５の近位端側の部分に沿って移動する場合、ガイドワイヤチューブ２は、該ガイドワイヤチューブ２を通過するガイドワイヤ５の形状に追随する。また、吸引カテーテル１０または１１がガイドワイヤ５の遠位端側の部分に沿って移動する場合、ガイドワイヤ５に柔軟性があるため、ガイドワイヤ５に対するガイドワイヤチューブ２の形状の追随性が遠位端へ向かうに従い小さくなる。例えば、ガイドワイヤ５の遠位端から３ｃｍの部分は、ガイドワイヤ５の形状がガイドワイヤチューブ２の形状に追随する程度の柔軟性を有する。 When the suction catheter 10 or 11 moves along the proximal end portion of the guide wire 5, the guide wire tube 2 follows the shape of the guide wire 5 passing through the guide wire tube 2. Further, when the suction catheter 10 or 11 moves along the distal end portion of the guide wire 5, the guide wire 5 is flexible, so that the followability of the shape of the guide wire tube 2 with respect to the guide wire 5 is far away. It becomes smaller as it goes to the end. For example, a portion of 3 cm from the distal end of the guide wire 5 has flexibility such that the shape of the guide wire 5 follows the shape of the guide wire tube 2.
　図３の（ａ）及び（ｂ）に示されるように、本発明の実施形態の前提となる吸引カテーテル１１では、吸引チューブ１がガイドワイヤ５に沿って移動し血栓６Ａに到達したとき、吸引口３ａにおける吸引力が大きい位置１ｂは、下側血管壁６ｂから距離Ｄ１離れたレベルＰ１に位置する。ガイドワイヤ５の血栓６Ａに近い遠位端側の部分は、柔軟性を有している。吸引カテーテル１１では、ガイドワイヤチューブ２は湾曲しておらず直線状であるため、ガイドワイヤ５の遠位端側の部分は直線状を維持している。 As shown in FIGS. 3A and 3B, in the suction catheter 11 which is the premise of the embodiment of the present invention, when the suction tube 1 moves along the guide wire 5 and reaches the thrombus 6A, suction is performed. position 1b attraction force is large in the mouth 3a is positioned from the lower vessel wall 6b at a distance D 1 apart level P 1. A portion of the guide wire 5 on the distal end side close to the thrombus 6A has flexibility. In the suction catheter 11, the guide wire tube 2 is not curved and is straight, so that the portion on the distal end side of the guide wire 5 is kept straight.
　一方、図３の（ｃ）及び（ｄ）に示されるように、本発明の実施形態の吸引カテーテル１０では、吸引チューブ１は、ガイドワイヤ５に沿って移動し血栓６Ａに到達したとき、位置１ｂは、下側血管壁６ｂから距離Ｄ２離れたレベルＰ２に位置する。ここで、ガイドワイヤ５の血栓６Ａに近い遠位端側の部分に柔軟性があるため、ガイドワイヤ５に対するガイドワイヤチューブ２の形状の追随性が遠位端へ向かうに従い小さくなる。吸引カテーテル１０は、少なくともガイドワイヤチューブ２に湾曲部４を有するため、ガイドワイヤ５が湾曲部４の形状に追随する作用と湾曲部４がガイドワイヤ５の形状に追随する作用と拮抗した状態となる。その結果、吸引カテーテル１０内に、吸引チューブ１の軸線Ｘとガイドワイヤチューブ２の軸線Ｙとが平行になるような力が働く。そして、この力と反作用の力（湾曲部４の状態に戻ろうとする力）が位置１ａに働く。その結果、ガイドワイヤチューブ２に位置１ｂ側に窪んだ凹部２ａが形成される。そして、この凹部２ａが形成されることにより、位置１ｂが下方へシフトする。 On the other hand, as shown in FIGS. 3C and 3D, in the suction catheter 10 of the embodiment of the present invention, the suction tube 1 moves along the guide wire 5 and reaches the thrombus 6A. 1b is positioned from the lower vessel wall 6b at a distance D 2 apart level P 2. Here, since the portion of the guide wire 5 on the distal end side near the thrombus 6A is flexible, the followability of the shape of the guide wire tube 2 with respect to the guide wire 5 becomes smaller toward the distal end. Since the suction catheter 10 has the bending portion 4 at least in the guide wire tube 2, the state in which the action of the guide wire 5 following the shape of the bending portion 4 and the action of the bending portion 4 following the shape of the guide wire 5 are antagonized. Become. As a result, a force is applied in the suction catheter 10 so that the axis X of the suction tube 1 and the axis Y of the guide wire tube 2 are parallel to each other. And this force and reaction force (force to return to the state of the bending portion 4) act on the position 1a. As a result, the guide wire tube 2 is formed with a recess 2a that is recessed toward the position 1b. And the position 1b shifts downward by forming this recessed part 2a.
　以上のことから、吸引カテーテル１０における位置１ｂと下側血管壁６ｂとの距離Ｄ２は、吸引カテーテル１１における位置１ｂと下側血管壁６ｂとの距離Ｄ１よりも小さくなる。このため、本実施形態に係る吸引カテーテル１０によれば、下側血管壁６ｂに付着した血栓６Ａを吸引する性能が向上する。 From the above, the distance D 2 between the position 1b and the lower blood vessel wall 6b in aspiration catheter 10 is smaller than the distance D 1 of the the position 1b and the lower blood vessel wall 6b in the suction catheter 11. For this reason, according to the suction catheter 10 according to the present embodiment, the performance of sucking the thrombus 6A attached to the lower blood vessel wall 6b is improved.
　また、血栓６Ａには繊維質が含まれる。このため、下側血管壁６ｂに付着した血栓６Ａに対する吸引力が不十分である場合、繊維質に引きずられて比較的大きな血栓６Ａが吸引口３ａから吸引される。それゆえ、吸引チューブ１が大きな血栓６Ａにより閉塞するおそれがある。これに対して、吸引カテーテル１０では、吸引力が最も高い位置１ｂと下側血管壁６ｂとの距離Ｄ２を小さくすることができるので、繊維質を含め血栓６Ａを細かく分割するのに十分な吸引力を実現できる。それゆえ、血栓６Ａによる吸引チューブ１の閉塞を防止することができる。 Further, the thrombus 6A contains a fibrous material. For this reason, when the suction force with respect to the thrombus 6A attached to the lower blood vessel wall 6b is insufficient, the relatively large thrombus 6A is sucked from the suction port 3a while being dragged by the fiber. Therefore, the suction tube 1 may be blocked by the large thrombus 6A. In contrast, in the aspiration catheter 10, the suction force it is possible to reduce the distance D 2 between the highest position 1b and the lower vessel wall 6b, sufficient to finely divided thrombus 6A including fibrous A suction force can be realized. Therefore, the suction tube 1 can be prevented from being blocked by the thrombus 6A.
　また、図２の（ａ）に示されるように、湾曲部４は、少なくともガイドワイヤチューブ２が湾曲する位置で湾曲していればよい。湾曲部４の湾曲許容部分Ｚは、ガイドワイヤチューブ２において、ガイドワイヤチューブ２の先端から、ガイドワイヤチューブ２の位置１ｂ’から位置１ａと反対側へ、つまり手元側へ最大５ｍｍの位置ｃまでの部分で湾曲していてもよい。また、位置ｃは、位置１ｂ’から手元側へ最大２ｍｍの位置であることが好ましい。また、湾曲部４は、ガイドワイヤチューブ２における位置１ｂから遠位端までの部分が湾曲していれば、少なくともガイドワイヤチューブ２が湾曲する。なお、ガイドワイヤチューブ２の位置１ｂ’とは、図２（ａ）において、位置１ｂを通り、吸引チューブ１の軸線Ｘに垂直な線がガイドワイヤチューブ２と交わる点である。 Further, as shown in FIG. 2A, the bending portion 4 may be bent at least at a position where the guide wire tube 2 is bent. In the guide wire tube 2, the bending allowable portion Z of the bending portion 4 is from the tip of the guide wire tube 2 to the position c of the guide wire tube 2 from the position 1 b ′ to the opposite side of the position 1 a, that is, to the position c of 5 mm at the maximum. The portion may be curved. Further, the position c is preferably a position of a maximum of 2 mm from the position 1b 'to the hand side. Moreover, if the part from the position 1b in the guide wire tube 2 to the distal end is curving, at least the guide wire tube 2 will bend. The position 1 b ′ of the guide wire tube 2 is a point where a line that passes through the position 1 b and is perpendicular to the axis X of the suction tube 1 intersects the guide wire tube 2 in FIG.
　図４は、吸引カテーテル１０がガイドワイヤ５に沿って屈曲する血管６を移動する様子を模式的に示す図である。図４の（ａ）は、吸引カテーテル１０が血管６の屈曲部分の外側の血管壁６ｄに接触する場合の様子を示す断面図である。図４の（ｂ）は、図４の（ａ）の状態での吸引口３ａの形状を示す図である。図４の（ｃ）は、吸引カテーテル１０が血管６の屈曲部分の内側の血管壁６ｅに接触する場合の様子を示す断面図である。図４の（ｂ）は、図４の（ｃ）の状態での吸引口３ａの形状を示す図である。 FIG. 4 is a diagram schematically showing how the suction catheter 10 moves along the blood vessel 6 bent along the guide wire 5. 4A is a cross-sectional view showing a state where the suction catheter 10 contacts the blood vessel wall 6d outside the bent portion of the blood vessel 6. FIG. FIG. 4B is a diagram illustrating the shape of the suction port 3a in the state of FIG. FIG. 4C is a cross-sectional view showing a state where the suction catheter 10 contacts the blood vessel wall 6e inside the bent portion of the blood vessel 6. FIG. FIG. 4B is a diagram illustrating the shape of the suction port 3a in the state of FIG.
　図４の（ａ）に示されるように、吸引カテーテル１０が血管６の屈曲部分の外側の血管壁６ｄに接触する場合、湾曲部４は、吸引チューブ１の軸線Ｘと交差するように、さらに位置１ｂ側へ湾曲するようになる。このとき、吸引口３ａの形状は、図４の（ｂ）に示されるように、縦方向（位置１ａと位置１ｂとを結ぶ直線の方向）に収縮し、略真円形状から横楕円形状となる。このように、吸引カテーテル１０が湾曲部４の湾曲する方向（位置１ｂ側への湾曲）と同じ方向に屈曲する血管６を通過するので、追随性が高くなる。 As shown in FIG. 4 (a), when the suction catheter 10 contacts the blood vessel wall 6d outside the bent portion of the blood vessel 6, the bending portion 4 further crosses the axis X of the suction tube 1. It curves to the position 1b side. At this time, as shown in FIG. 4B, the shape of the suction port 3a contracts in the vertical direction (the direction of a straight line connecting the position 1a and the position 1b), and changes from a substantially perfect circle shape to a horizontal elliptical shape. Become. Thus, since the suction catheter 10 passes through the blood vessel 6 that bends in the same direction as the bending direction of the bending portion 4 (bending toward the position 1b), the followability increases.
　図４の（ｃ）に示されるように、吸引カテーテル１０が血管６の屈曲部分の内側の血管壁６ｅに接触する場合、湾曲部４は、吸引チューブ１の軸線Ｘから離間するように、位置１ｂと反対側の位置１ａ側へ湾曲するようになる。また、吸引口３ａの形状は、図４の（ｄ）に示されるように、縦方向に伸長し、真円形状から縦楕円形状となる。このとき、吸引カテーテル１０の位置１ｂ部分（顎部）は、位置１ａ側へ伸長する。このため、位置１ｂ部分（顎部）と血管６の屈曲部分の外側の血管壁６ｄとの引っ掛かりを抑えることができる。 As shown in FIG. 4C, when the suction catheter 10 contacts the blood vessel wall 6 e inside the bent portion of the blood vessel 6, the bending portion 4 is positioned so as to be separated from the axis X of the suction tube 1. It curves to the position 1a side opposite to 1b. The shape of the suction port 3a extends in the vertical direction as shown in FIG. 4D, and changes from a perfect circle shape to a vertical ellipse shape. At this time, the position 1b portion (jaw) of the suction catheter 10 extends toward the position 1a. For this reason, it is possible to suppress the catch between the position 1b portion (jaw portion) and the blood vessel wall 6d outside the bent portion of the blood vessel 6.
　（本実施形態に係る吸引カテーテルの製造方法）
　本実施形態に係る吸引カテーテル１０の製造方法は、少なくともガイドワイヤチューブ２における吸引口３ａ側の端部を位置１ｂ側へ湾曲する湾曲工程を含んでいれば、特に限定されない。 (Method of manufacturing a suction catheter according to the present embodiment)
The manufacturing method of the suction catheter 10 according to the present embodiment is not particularly limited as long as it includes a bending step of bending at least the end portion of the guide wire tube 2 on the suction port 3a side toward the position 1b.
　湾曲工程としては、例えば、従来公知の製造方法により吸引チューブ１及びガイドワイヤチューブ２を溶着して図３の（ａ）に示す吸引カテーテル１１を製造しておき、この吸引カテーテル１１を湾曲する方法が挙げられる。吸引カテーテル１１の湾曲方法としては、例えば、まず、吸引カテーテル１１のガイドワイヤチューブ２内に、曲げ加工した金属芯材を挿入する。その後、吸引チューブ１及びガイドワイヤチューブ２の融点以下で加熱加工及び冷却を施す。そして、最後に、上記金属芯材をガイドワイヤチューブ２から引き抜くことにより、湾曲部４が形成された吸引カテーテル１０を得る。 As the bending step, for example, the suction tube 1 and the guide wire tube 2 are welded by a conventionally known manufacturing method to manufacture the suction catheter 11 shown in FIG. 3A, and the suction catheter 11 is bent. Is mentioned. As a method for bending the suction catheter 11, for example, first, a bent metal core material is inserted into the guide wire tube 2 of the suction catheter 11. Thereafter, heat processing and cooling are performed below the melting points of the suction tube 1 and the guide wire tube 2. Finally, by pulling out the metal core material from the guide wire tube 2, the suction catheter 10 in which the curved portion 4 is formed is obtained.
　また、上述した方法以外に、例えば、湾曲部４を有するガイドワイヤチューブ２、及び湾曲部４に沿って湾曲する吸引チューブ１を予め作製し、両チューブを従来公知の方法により溶着する方法も挙げられる。 In addition to the method described above, for example, a guide wire tube 2 having a curved portion 4 and a suction tube 1 that is curved along the curved portion 4 are prepared in advance, and both the tubes are welded by a conventionally known method. It is done.
　〔まとめ〕
　本発明の一実施形態に係る吸引カテーテル１０は、先端に吸引部３を有する第１ルーメンとしての吸引ルーメン１Ａを備えた第１チューブとしての吸引チューブ１と、吸引チューブ１の吸引部３側に設けられ、ガイドワイヤ５が挿通する第２ルーメンとしてのガイドワイヤルーメン２Ａを有する第２チューブとしてのガイドワイヤチューブ２と、を備え、吸引部３は、吸引チューブ１の軸線Ｘに対して傾斜して形成された吸引口３ａを有する吸引カテーテル１０であって、吸引部３における最も先端位置を位置１ａ（第１位置）とし、第１位置から最も遠い位置を位置１ｂ（第２位置）とすると、少なくともガイドワイヤチューブ２における吸引口３ａ側の端部が位置１ｂ側へ湾曲した湾曲部４を備えていることを特徴としている。換言すると、湾曲部４は、吸引部３おける最遠近端位置としての位置１ａが、最近位端位置としての位置１ｂ側へ湾曲した構成であるといえる。 [Summary]
A suction catheter 10 according to an embodiment of the present invention includes a suction tube 1 as a first tube provided with a suction lumen 1A as a first lumen having a suction portion 3 at a distal end, and a suction portion 3 side of the suction tube 1. A guide wire tube 2 as a second tube having a guide wire lumen 2A as a second lumen through which the guide wire 5 is inserted, and the suction part 3 is inclined with respect to the axis X of the suction tube 1 In the suction catheter 10 having the suction port 3a formed in this manner, the most distal position in the suction part 3 is defined as position 1a (first position), and the position farthest from the first position is defined as position 1b (second position). The guide wire tube 2 includes a curved portion 4 that is curved toward the position 1b at least at the end on the suction port 3a side. In other words, it can be said that the bending portion 4 has a configuration in which the position 1a as the farthest near end position in the suction portion 3 is curved toward the position 1b as the nearest end position.
　上記の構成によれば、少なくともガイドワイヤチューブ２における吸引口３ａ側の端部が位置１ｂ側へ湾曲した湾曲部４を備えているので、吸引チューブ１がガイドワイヤ５に沿って移動し血栓に到達したとき、吸引カテーテル１０における最も吸引力が高い位置１ｂを下側血管壁に接近し、位置１ｂと下側血管壁との距離が小さくなる。このため、上記の構成によれば、下側血管壁に付着した血栓を吸引することができ、吸引性能が向上する。 According to the above configuration, at least the end of the guide wire tube 2 on the suction port 3a side is provided with the curved portion 4 curved toward the position 1b, so that the suction tube 1 moves along the guide wire 5 and becomes a thrombus. When the position reaches, the position 1b having the highest suction force in the suction catheter 10 approaches the lower blood vessel wall, and the distance between the position 1b and the lower blood vessel wall decreases. For this reason, according to said structure, the thrombus adhering to the lower blood vessel wall can be attracted | sucked and suction performance improves.
　本発明の一実施形態に係る吸引カテーテル１０では、湾曲部４は、第１チューブとしての吸引チューブ１の軸線Ｘと交差していることが好ましい。 In the suction catheter 10 according to an embodiment of the present invention, it is preferable that the curved portion 4 intersects the axis X of the suction tube 1 as the first tube.
　これにより、吸引チューブ１がガイドワイヤ５に沿って移動し血栓に到達したとき、吸引カテーテル１０における位置１ｂを下側血管壁のより近くに接近させることができる。 Thereby, when the suction tube 1 moves along the guide wire 5 and reaches the thrombus, the position 1b in the suction catheter 10 can be brought closer to the lower blood vessel wall.
　本発明の一実施形態に係る吸引カテーテル１０では、第１チューブとしての吸引チューブ１と第２チューブとしてのガイドワイヤチューブ２とが、全長に亘って互いの軸線Ｘ及びＹが平行になるように配されたとき、湾曲部４には、位置１ｂ（第２位置）側へ窪んだ凹部２ａが形成されることが好ましい。 In the suction catheter 10 according to an embodiment of the present invention, the suction tube 1 as the first tube and the guide wire tube 2 as the second tube are arranged such that their axes X and Y are parallel over the entire length. When arranged, the curved portion 4 is preferably formed with a recess 2a that is recessed toward the position 1b (second position).
　上記の構成によれば、全長に亘って互いの軸線Ｘ及びＹが平行になるように配されたとき、湾曲部４には、位置１ｂ（第２位置）側へ窪んだ凹部２ａが形成されるので、吸引カテーテル１０は、この凹部２ａにより、位置１ｂが下方へシフトする。したがって、上記の構成によれば、吸引チューブ１がガイドワイヤ５に沿って移動し血栓に到達したとき、吸引カテーテル１０における位置１ｂを下側血管壁のより確実に接近させることができる。 According to said structure, when it arrange | positions so that mutual axis line X and Y may become parallel over the full length, the recessed part 2a hollowed in the position 1b (2nd position) side is formed in the curved part 4. FIG. Thus, the position 1b of the suction catheter 10 is shifted downward by the recess 2a. Therefore, according to the above configuration, when the suction tube 1 moves along the guide wire 5 and reaches the thrombus, the position 1b in the suction catheter 10 can be brought closer to the lower blood vessel wall more reliably.
　本発明の一実施形態に係る吸引カテーテル１０において、湾曲部４では、前記第２チューブとしてのガイドワイヤチューブ２において、その先端から、第１チューブとしての吸引チューブ１の吸引部３における位置１ｂ（第２位置）から位置１ａ（第１位置）と反対側へ最大２ｍｍの位置までの部分が湾曲していてもよい。 In the suction catheter 10 according to an embodiment of the present invention, in the bending portion 4, the guide wire tube 2 as the second tube has a position 1b (in the suction portion 3 of the suction tube 1 as the first tube from the tip thereof. A portion from the second position) to the position opposite to the position 1a (first position) up to a position of 2 mm may be curved.
　本発明の一実施形態に係る吸引カテーテル１０の製造方法は、先端に吸引部３を有する第１ルーメンとしての吸引ルーメン１Ａを備えた第１チューブとしての吸引チューブ１と、吸引チューブ１の吸引部３側に設けられ、ガイドワイヤ５が挿通する第２ルーメンとしてのガイドワイヤルーメン２Ａを有する第２チューブとしてのガイドワイヤチューブ２と、を備え、吸引部３は、吸引チューブ１の軸線Ｘに対して傾斜して形成された吸引口３ａを有する吸引カテーテル１０での製造方法であって、吸引部３における最も先端位置を位置１ａ（第１位置）とし、第１位置から最も遠い位置を位置１ｂ（第２位置）とすると、少なくともガイドワイヤチューブ２における吸引口３ａ側の端部を位置１ｂ側へ湾曲する湾曲工程を含むことを特徴としている。 The manufacturing method of the suction catheter 10 according to one embodiment of the present invention includes a suction tube 1 as a first tube having a suction lumen 1A as a first lumen having a suction portion 3 at the tip, and a suction portion of the suction tube 1 3, and a guide wire tube 2 as a second tube having a guide wire lumen 2 </ b> A as a second lumen through which the guide wire 5 is inserted, and the suction unit 3 is arranged with respect to the axis X of the suction tube 1. In the manufacturing method using the suction catheter 10 having the suction port 3a formed to be inclined, the distal end position in the suction part 3 is defined as a position 1a (first position), and the position farthest from the first position is defined as a position 1b. (Second position), characterized in that it includes a bending step of bending at least the end of the guide wire tube 2 on the suction port 3a side toward the position 1b. To have.
　上記の構成によれば、吸引性能が向上した吸引カテーテル１０を製造することができる。 According to the above configuration, the suction catheter 10 with improved suction performance can be manufactured.
　本発明は上述した実施形態に限定されるものではなく、請求項に示した範囲で種々の変更が可能であり、実施形態にそれぞれ開示された技術的手段を適宜組み合わせて得られる実施形態についても本発明の技術的範囲に含まれる。 The present invention is not limited to the above-described embodiments, and various modifications can be made within the scope shown in the claims, and embodiments obtained by appropriately combining technical means disclosed in the embodiments are also included. It is included in the technical scope of the present invention.
　１　吸引チューブ（第１チューブ）
１Ａ　吸引ルーメン（第１ルーメン）
１ａ　位置（第１の位置）
１ｂ　位置（第２の位置）
　２　ガイドワイヤチューブ（第２チューブ）
２Ａ　ガイドワイヤルーメン（第２ルーメン）
２ａ　凹部
　３　吸引部
３ａ　吸引口
　４　湾曲部
　５　ガイドワイヤ
　６　血管
　６Ａ　血栓
１０　吸引カテーテル 1 Suction tube (first tube)
1A Suction lumen (first lumen)
1a position (first position)
1b position (second position)
2 Guide wire tube (second tube)
2A Guide wire lumen (second lumen)
2a Concave part 3 Suction part 3a Suction port 4 Bending part 5 Guide wire 6 Blood vessel 6A Thrombus 10 Suction catheter

Claims (5)

  1. 　先端に吸引部を有する第１ルーメンを備えた第１チューブと、
    　前記第１チューブの前記吸引部側に設けられ、ガイドワイヤが挿通する第２ルーメンを有する第２チューブと、を備え、前記吸引部は、前記第１チューブの軸線に対して傾斜して形成された吸引口を有する吸引カテーテルであって、
    　前記吸引部における最も先端位置を第１位置とし、該第１位置から最も遠い位置を第２位置とすると、
    　少なくとも前記第２チューブにおける前記吸引口側の端部が前記第２位置側へ湾曲した湾曲部を備えていることを特徴とする吸引カテーテル。     A first tube with a first lumen having a suction portion at the tip;
    And a second tube having a second lumen through which a guide wire is inserted, and the suction portion is formed to be inclined with respect to the axis of the first tube. A suction catheter having a suction port,
    When the most distal end position in the suction part is the first position and the farthest position from the first position is the second position,
    An aspiration catheter characterized in that at least an end on the suction port side of the second tube is provided with a curved portion curved toward the second position.
  2. 　前記湾曲部は、前記第１チューブの軸線と交差していることを特徴とする請求項１に記載の吸引カテーテル。 The suction catheter according to claim 1, wherein the curved portion intersects the axis of the first tube.
  3. 　前記第１チューブと前記第２チューブとが、全長に亘って互いの軸線が平行になるように配されたとき、
    　前記湾曲部には、前記第２位置側へ窪んだ凹部が形成されることを特徴とする請求項１または２に記載の吸引カテーテル。     When the first tube and the second tube are arranged so that their axes are parallel over the entire length,
    The suction catheter according to claim 1, wherein a concave portion that is recessed toward the second position is formed in the curved portion.
  4. 　前記湾曲部では、前記第２チューブにおいて、その先端から、前記第２位置から前記第１位置と反対側へ最大２ｍｍの位置までの部分が湾曲していることを特徴とする請求項１～３の何れか１項に記載の吸引カテーテル。 The curved portion is characterized in that a portion of the second tube from the distal end to a position of a maximum of 2 mm from the second position to the opposite side of the first position is curved. The suction catheter according to any one of the above.
  5. 　先端に吸引部を有する第１ルーメンを備えた第１チューブと、
    　前記第１チューブの前記吸引部側に設けられ、ガイドワイヤが挿通する第２ルーメンを有する第２チューブと、を備え、前記吸引部は、前記第１チューブの軸線に対して傾斜して形成された吸引口を有する吸引カテーテルの製造方法であって、
    　前記吸引部における最も先端位置を第１位置とし、該第１位置から最も遠い位置を第２位置とすると、
    　少なくとも前記第２チューブにおける前記吸引口側の端部を前記第２位置側へ湾曲する湾曲工程を含むことを特徴とする吸引カテーテルの製造方法。     A first tube with a first lumen having a suction portion at the tip;
    And a second tube having a second lumen through which a guide wire is inserted, and the suction portion is formed to be inclined with respect to the axis of the first tube. A method for producing a suction catheter having a suction port comprising:
    When the most distal end position in the suction part is the first position and the farthest position from the first position is the second position,
    A method for producing a suction catheter, comprising: a bending step of bending at least an end of the second tube on the suction port side toward the second position.
PCT/JP2018/000679 2017-02-17 2018-01-12 Suction catheter WO2018150772A1 (en)

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