WO2024143282A1 - カテーテル - Google Patents

カテーテル Download PDF

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Publication number
WO2024143282A1
WO2024143282A1 PCT/JP2023/046448 JP2023046448W WO2024143282A1 WO 2024143282 A1 WO2024143282 A1 WO 2024143282A1 JP 2023046448 W JP2023046448 W JP 2023046448W WO 2024143282 A1 WO2024143282 A1 WO 2024143282A1
Authority
WO
WIPO (PCT)
Prior art keywords
catheter
wires
spiral
wire
spiral portion
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/JP2023/046448
Other languages
English (en)
French (fr)
Japanese (ja)
Inventor
正憲 北川
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Piolax Medical Devices Inc
Original Assignee
Piolax Medical Devices Inc
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 Piolax Medical Devices Inc filed Critical Piolax Medical Devices Inc
Priority to KR1020257021369A priority Critical patent/KR20250154360A/ko
Priority to CN202380089737.2A priority patent/CN120456949A/zh
Priority to JP2024567807A priority patent/JP7850825B2/ja
Publication of WO2024143282A1 publication Critical patent/WO2024143282A1/ja
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/0043Catheters; Hollow probes characterised by structural features
    • A61M25/005Catheters; Hollow probes characterised by structural features with embedded materials for reinforcement, e.g. wires, coils, braids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/0043Catheters; Hollow probes characterised by structural features
    • A61M25/0045Catheters; Hollow probes characterised by structural features multi-layered, e.g. coated

Definitions

  • catheters have been inserted into tubular organs such as blood vessels, ureters, bile ducts, and tracheas, and into human tissues such as body cavities, and contrast agents, anticancer drugs, nutrients, etc., have been injected through the catheter, and stents, vascular occlusion devices, etc. have been placed in combination with guidewires, etc.
  • the wires constituting the first spiral portion and the wires constituting the second spiral portion are arranged with a predetermined gap between them, and the gap between the wires constituting the first spiral portion is wider than the gap between the wires constituting the second spiral portion (see Figure 4 of Patent Document 1).
  • the first and second spiral portions are wound around the entire axial area (from the base end to the tip end) with gaps between the wires, which may result in poor flexibility.
  • the object of the present invention is therefore to provide a catheter that can increase flexibility while maintaining kink resistance.
  • the second spiral portion has parallel contact portions arranged in parallel so as to contact at least two second wires, and the parallel contact portions are formed by winding with a predetermined gap between them, so that the parallel contact portions maintain kink resistance while the gap between the parallel contact portions increases flexibility.
  • the catheter 10 of this embodiment has a tube including a braided reinforcing member 40.
  • the tube has an internal lumen.
  • the tube that constitutes the catheter 10 has an inner layer 20 and an outer layer 30 that is disposed on the outside of the inner layer 20.
  • tip refers to the distal end, the distal end and the distal end side that is farthest from the hand of the catheter operator
  • base end refers to the proximal end, the proximal end and the proximal end side that is closest to the hand of the catheter operator.
  • the axis of the catheter 10 is defined as “axis C”, and the direction along this axis C is defined as the axial direction (the same applies to the axial direction of each component).
  • the inner layer 20 in this embodiment is composed of a base 21 that extends a predetermined length with a constant diameter, a tapered portion 23 that extends from the tip of the base 21 while gradually reducing in diameter toward the very end of the inner layer 20, and a tip portion 25 that extends a predetermined length from the tip of the tapered portion 23 with a constant diameter that is smaller than the outer diameter of the base 21.
  • the inner layer 20 may be made of, for example, fluororesins such as polytetrafluoroethylene (PTFE), perfluoroalkoxy resin (PFA), tetrafluoroethylene-hexafluoropropylene copolymer (FEP), tetrafluoroethylene-ethylene copolymer (ETFE), polyurethane, nylon elastomer, polyether block amide, polyethylene, polyvinyl chloride, vinyl acetate, ultraviolet curing resin, or resins used in adhesives (acrylate resin, urethane-based, epoxy-based, silicone-based). Note that the inner layer 20 in this embodiment is made of polytetrafluoroethylene (PTFE).
  • PTFE polytetrafluoroethylene
  • PFA perfluoroalkoxy resin
  • FEP tetrafluoroethylene-hexafluoropropylene copolymer
  • ETFE tetrafluoroethylene-ethylene copolymer
  • polyurethane nylon e
  • the outer layer 30 is made up of a first layer 31, a second layer 32, a third layer 33, a fourth layer 34, and a fifth layer 35 arranged in the axial direction from the base end of the tube to the tip end.
  • the first layer 31 is disposed in a predetermined range of the base 21 of the inner layer 20.
  • the second layer 32 is disposed on the base 21 of the inner layer 20, on the distal side of the location of the first layer 31.
  • the third layer 33 is disposed in a range extending from the distal side of the location of the second layer 32 on the base 21 of the inner layer 20, via the tapered portion 23, to the proximal side of the distal portion 25.
  • the fourth layer 34 is disposed within a predetermined range from the tip side of the tip portion 25 of the inner layer 20 relative to the location of the third layer 33. Furthermore, the fifth layer 35 is disposed on the tip side of the tip portion 25 of the inner layer 20 relative to the location of the fourth layer 34.
  • each of the layers 31 to 35 constituting the outer layer 30 can be made of, for example, polyurethane, polyester, nylon elastomer, polyether block amide, polyethylene, polyvinyl chloride, vinyl acetate, UV-curable resin, resins used in adhesives (acrylate resin, urethane-based, epoxy-based, silicone-based), fluorine-based resins such as polytetrafluoroethylene (PTFE), perfluoroalkoxy resin (PFA), tetrafluoroethylene-hexafluoropropylene copolymer (FEP), and tetrafluoroethylene-ethylene copolymer (ETFE).
  • PTFE polytetrafluoroethylene
  • PFA perfluoroalkoxy resin
  • FEP tetrafluoroethylene-hexafluoropropylene copolymer
  • ETFE tetrafluoroethylene-ethylene copolymer
  • each layer 31 to 35 is set so that the first layer 31 is the hardest and gradually decreases toward the fifth layer 35, from the viewpoint of ensuring operability and torque transmission.
  • the fifth layer 35 arranged on the tip side of the outer layer 30 has an X-ray opaque marker 37 embedded therein, which is made of an X-ray opaque metal such as W, Pt, Ti, Pd, Rh, Au, Ag, Bi, Ta, Ir, or an alloy thereof.
  • the outer periphery of the outer layer 30 is coated with a hydrophilic resin film 39 made of, for example, polyvinylpyrrolidone, polyethylene glycol, methyl vinyl ether maleic anhydride copolymer, etc.
  • the reinforcing member 40 has a first spiral section 50 formed by winding the first wire 51 with a predetermined gap between them in a first spiral direction, and a second spiral section 60 formed by winding the second wire 61 in a second spiral direction different from the first spiral direction (the second spiral section 60 in which the second wire 61 is wound in a second spiral direction different from the first spiral direction and arranged so that the second wire 61 crosses the first wire 51 of the first spiral section 50).
  • the first wire 51 and the second wire 61 are both round wires with a circular cross section.
  • Figure 2 is a cross-sectional view taken along the line A-A in Figure 1, that is, a cross-sectional view taken when cutting the catheter 10 at a specific position on the tip side and looking from the base end side of the catheter 10 toward the tip side.
  • Figure 3 shows the catheter 10 without the outer layer 30.
  • the right side of the drawing is the base end side of the catheter 10
  • the left side of the drawing is the tip side of the catheter 10.
  • first spiral direction R1 (hereinafter also simply referred to as “first spiral direction R1”) is determined by the inclination angle ⁇ 1 of the first wire 51 relative to the axis C of the catheter 10 and the winding direction of the first wire 51
  • second spiral direction R2 (hereinafter also simply referred to as “second spiral direction R2”) is determined by the inclination angle ⁇ 2 of the second wire 61 relative to the axis C of the catheter 10 and the winding direction of the second wire 61.
  • the first spiral portion 50 is formed by inclining the first wire 51 at a predetermined angle ⁇ 1 with respect to the axis C of the catheter 10, and winding it in a right-handed (clockwise) spiral shape when the reinforcing member 40 is viewed from the base end side to the tip end side of the catheter 10, as shown in FIG. 2.
  • the first wires 51, 51 are arranged with a predetermined gap S1 (see FIG. 3) in the axial direction of the first spiral portion 50.
  • This gap S1 is wider at the base end side than at the tip end side of the first spiral portion 50.
  • the middle portion of the first spiral portion 50 is shown, and in this middle portion, the gap S1 between the first wires 51, 51 is almost constant, but the gap S1 on the base end side of the middle portion shown in FIG. 3 (right side in FIG. 3) is wider than the gap S1 on the tip side of the middle portion shown in FIG. 3 (left side in FIG. 3).
  • the gap S1 is the length between the tangent at one widthwise edge (the right side edge in FIG. 3) of a given first wire 51 and the tangent at the other widthwise edge (the left side edge in FIG. 3) of another first wire 51 that is adjacent to the given first wire 51 in the axial direction of the first spiral portion 50.
  • the gap S1 between the first wires 51, 51 of the first spiral portion 50 is preferably 0.03 to 0.25 mm, and more preferably 0.06 to 0.20 mm.
  • the first spiral portion 50 is made up of eight first wires 51a, 51b, 51c, 51d, 51e, 51f, 51g, and 51h, which are wound around the first spiral portion 50 in the axial direction while maintaining a predetermined gap S1.
  • first wires 51a, 51b, 51c, 51d, 51e, 51f, 51g, and 51h are arranged in this order from the tip side to the base end side of the first spiral section 50. After first wire 51h, first wire 51a is again arranged.
  • the angle ⁇ 1 of the first wire 51 forming the first spiral portion 50 with respect to the axis C of the catheter 10 is preferably 100 to 140°, and more preferably 110 to 130°.
  • the second spiral portion 60 is formed by inclining the second wire 61 at a predetermined angle ⁇ 2 with respect to the axis C of the catheter 10, and winding it in a spiral shape in a direction different from the first spiral direction R1, here counterclockwise, when the reinforcing member 40 is viewed from the base end side to the tip end side of the catheter 10 as shown in FIG. 2.
  • the second spiral portion 60 has parallel contact portions 65 arranged in parallel so as to contact at least two second wires 61, and is formed by winding the parallel contact portions 65, 65 with a predetermined gap between them.
  • two second wires 61, 61 are arranged in parallel so as to be in contact with each other (the second wires 61, 61 are arranged in parallel so as to be in contact with each other without any gaps), thereby forming a parallel contact portion 65.
  • one side edge in the width direction of one second wire 61 comes into contact with the other side edge in the width direction of the other second wire 61 that is arranged adjacent to this second wire 61 in the axial direction of the second spiral portion 60 (the left side edge of the second wire 61 located on the right side of the two second wires 61, 61 that make up the parallel contact portion 65 in FIG. 3), thereby forming a set of two parallel contact portions 65.
  • the pair of parallel contact portions 65, 65 are arranged with a predetermined gap S2 (see FIG. 3) between them in the axial direction C of the second spiral portion 60.
  • This gap S2 is wider at the base end side than at the tip end side of the second spiral portion 60.
  • the middle portion of the second spiral portion 60 is shown, and in this middle portion, the gap S2 between the second wires 61, 61 is almost constant, but the gap S2 on the base end side of the middle portion shown in FIG. 3 (right side in FIG. 3) is wider than the gap S2 on the tip side of the middle portion shown in FIG. 3 (left side in FIG. 3).
  • the gap S2 is the length between the tangent at one side edge in the width direction of the given parallel contact portion 65 (the side edge of the second wire rod 61 on the right side that constitutes the given parallel contact portion 65 in FIG. 3) and the tangent at the other side edge in the width direction of another parallel contact portion 65 that is arranged adjacent to the given parallel contact portion 65 in the axial direction of the second spiral portion 60 (the side edge of the second wire rod 61 on the left side that constitutes the other parallel contact portion 65 in FIG. 3).
  • the gap S2 between the parallel contact portions 65, 65 of the second spiral portion 60 is preferably 0.06 to 0.50 mm, and more preferably 0.12 to 0.40 mm.
  • the second spiral portion 60 is composed of eight second wires 61a, 61b, 61c, 61d, 61e, 61f, 61g, and 61h, with the second wires 61a and 61b in contact with each other, the second wires 61c and 61d in contact with each other, the second wires 61e and 61f in contact with each other, and the second wires 61g and 61h in contact with each other, forming a pair of parallel contact portions 65, which are wound around the second spiral portion 60 in the axial direction while maintaining a predetermined gap S2.
  • second wires 61a, 61b, 61c, 61d, 61e, 61f, 61g, and 61h are arranged in order from the tip side to the base end side of the second spiral portion 60, and the above combination constitutes one parallel contact portion 65.
  • another parallel contact portion 65 consisting of second wires 61a and 61b is arranged.
  • the parallel contact portion 65 consisting of two second wires 61, 61 in contact with each other is located outside (radially outside) the first wire 51 at two predetermined locations in the traveling direction of the second spiral direction R2, located inside (radially inside) the first wire 51 at the next two locations, and then located outside the first wire 51 again at the next two locations, and thereafter, alternately located outside and inside the first wire 51, i.e., inside, outside, inside the first wire 51, by being woven while crossing the first wire 51 of the first spiral portion 50, to form the second spiral portion 60.
  • the gap S2 between the parallel contact portions 65, 65 of the second spiral portion 60 is set to be wider than the gap S1 between the first wires 51, 51 of the first spiral portion 50.
  • the space K1 formed by the multiple first wires 51 of the first spiral section 50 and the multiple second wires 61 of the second spiral section 60 being arranged crosswise is approximately parallelogram-shaped (the parallel contact portions 65, 65 are arranged on the short side, and the first wires 51, 51 are arranged on the long side, and the area surrounded by them) and this approximately parallelogram-shaped space K1 is arranged over the entire area from the tip to the base end of the reinforcing member 40.
  • each space K1 is configured so that its area is smaller on the tip side than on the base side of the reinforcing member 40.
  • FIG. 3 shows the middle part of the reinforcing member 40, and each space K1 in this middle part has approximately the same area, but the area of each space K1 on the tip side of the part shown in FIG. 3 (left side in FIG. 3) is smaller than the area of each space K1 on the base side of the middle part shown in FIG. 3 (right side in FIG. 3).
  • the number of first wires 51 forming the first spiral portion 50 is the same as the number of second wires 61 forming the second spiral portion 60.
  • the first wires 51 forming the first spiral portion 50 are eight wires, namely, 51a, 51b, 51c, 51d, 51e, 51f, 51g, and 51h
  • the second wires 61 forming the second spiral portion 60 are also eight wires, namely, 61a, 61b, 61c, 61d, 61e, 61f, 61g, and 61h, which is the same number.
  • the catheter 10 is arranged so that at least the parallel contact portion 65 is in contact with the outer periphery of the inner layer 20, and is configured so that the outer layer 30 does not get between the outer periphery of the inner layer 20 and the second wires 61, 61 that constitute the parallel contact portion 65 arranged in contact with the outer periphery.
  • a parallel contact portion 65 consisting of two second wires 61, 61 is arranged so as to contact the outer periphery of the inner layer 20.
  • a predetermined gap K2 is defined between the outer periphery of the inner layer 20 and the second wires 61, 61 that constitute the parallel contact portion 65, and the outer layer 30 does not enter the gap K2.
  • a first wire 51 is further arranged in contact with the outer side (radially outer side) of the two second wires 61, 61.
  • the outer layer 30 penetrates the outside of the second wires 61, 61 and the first wire 51 that constitute the parallel contact portion 65, and also penetrates into the space K1 formed by the intersection of the wires 51, 61. It can also be said that the second wires 61, 61 and the first wire 51 are embedded inside the outer layer 30. As a result, the displacement of the second wires 61, 61 and the first wire 51 relative to the inner layer 20 (displacement radially outward and displacement in the circumferential direction) is restricted.
  • the parallel contact portions 65 have a knitting pattern that crosses the first wire 51 so as to be alternately positioned on the outside and inside of the first wire 51 (see paragraph 0046), so that the parallel contact portions 65 have portions that contact the outer periphery of the inner layer 20 and portions that do not contact the outer periphery of the inner layer 20 along the spiral trajectory of the second spiral direction R2 of the second spiral portion 60.
  • the parallel contact portions 65 do not all abut against the outer periphery of the inner layer 20, but rather abutting portions and non-abutting portions are alternately positioned along the spiral trajectory of the second spiral direction R2.
  • the reinforcing member 40 is not positioned all the way to the very tip of the inner layer 20, but is positioned in a range from a predetermined position on the inner layer 20 to just before the very tip. In other words, the reinforcing member 40 is not positioned at the very tip of the outer layer 30. As a result, flexibility is ensured at the very tip of the catheter 10.
  • the angle ⁇ 2 of the second wire 61 forming the second spiral portion 60 with respect to the axis C of the catheter 10 is preferably 100 to 140°, and more preferably 110 to 130°.
  • the first wire 51 and the second wire 61 are W.
  • the wire diameter of the first wire 51 and the second wire 61 is preferably 0.010 to 0.050 mm, and more preferably 0.015 to 0.030 mm. Furthermore, the outer diameter of the reinforcing member 40 is preferably 0.40 to 5.00 mm, and more preferably 0.50 to 1.00 mm.
  • the outer layer 30 is formed by layers 31, 32, 33, 34, and 35 of different hardness arranged in the axial direction, but the outer layer may be a single layer made of the same material from the base end to the tip.
  • the first spiral direction R1 of the first spiral portion 50 constituting the reinforcing member 40 is clockwise
  • the second spiral direction R2 of the second spiral portion 60 is counterclockwise; however, for example, the first spiral direction R1 of the first spiral portion and the second spiral direction R2 of the second spiral portion may both be clockwise or counterclockwise, and the inclination angle ⁇ 1 of the first wire 51 relative to the axis C of the catheter 10 and the inclination angle ⁇ 2 of the second wire 61 relative to the axis C of the catheter 10 may be different angles, as long as the first spiral direction R1 and the second spiral direction R2 are different.
  • the parallel contact portion 65 is formed by arranging two second wires 61 in parallel so that they are in contact with each other, but the number of second wires 61 that form the parallel contact portion may be three or more.
  • the gap S2 between the parallel contact portions 65, 65 of the second spiral portion 60 is set to be wider than the gap S1 between the first wires 51, 51 of the first spiral portion 50, but the gap S2 may be narrower than the gap S1, or both gaps S1, S2 may be the same.
  • first wires 51 forming the first spiral portion 50 and the number of second wires 61 forming the second spiral portion 60 are the same, but the number of first wires and the number of second wires may be different, and the number of either the first wires or the second wires may be greater or less than the other.
  • the knitting pattern of the parallel contact portion 65 with respect to the first wire 51 is such that, in the traveling direction of the second spiral direction R2, the parallel contact portion 65 alternately crosses the first wire 51 at two points on the outside and inside (see FIG. 3), but it may alternatively be such that the parallel contact portion 65 alternately crosses the first wire at one point on the outside and inside (see FIG. 3).
  • the gap S1 between the first wires 51, 51 of the first spiral portion 50 is wider at the base end side of the first spiral portion 50 than at the tip end side, but this gap S1 may be constant over the entire axial length from the base end to the tip end of the first spiral portion 50, or may be wider at the tip end side of the first spiral portion 50 than the base end side, or may be gradually wider or narrower from the base end to the tip end of the first spiral portion 50.
  • the second spiral portion 60 has parallel contact portions 65 that are arranged in parallel so that at least two second wires 61, 61 are in contact with each other, and the parallel contact portions 65, 65 are wound around each other with a predetermined gap therebetween.
  • the outer diameter direction dimension meaning the vertical dimension in the plane of FIG. 4; see the arrow in FIG. 4
  • the outer diameter of the catheter 10 can be made smaller.
  • the number of first wires 51 forming the first spiral portion 50 and the number of second wires 61 forming the second spiral portion 60 are the same, so that it is easier to widen the gap between the parallel contact portions 65, 65 in the second spiral portion 60, and the flexibility of the catheter 10 can be further improved.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biophysics (AREA)
  • Pulmonology (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
PCT/JP2023/046448 2022-12-28 2023-12-25 カテーテル Ceased WO2024143282A1 (ja)

Priority Applications (3)

Application Number Priority Date Filing Date Title
KR1020257021369A KR20250154360A (ko) 2022-12-28 2023-12-25 카테터
CN202380089737.2A CN120456949A (zh) 2022-12-28 2023-12-25 导管
JP2024567807A JP7850825B2 (ja) 2022-12-28 2023-12-25 カテーテル

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2022211066 2022-12-28
JP2022-211066 2022-12-28

Publications (1)

Publication Number Publication Date
WO2024143282A1 true WO2024143282A1 (ja) 2024-07-04

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ID=91718001

Family Applications (1)

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PCT/JP2023/046448 Ceased WO2024143282A1 (ja) 2022-12-28 2023-12-25 カテーテル

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JP (1) JP7850825B2 (https=)
KR (1) KR20250154360A (https=)
CN (1) CN120456949A (https=)
WO (1) WO2024143282A1 (https=)

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040143239A1 (en) * 2003-01-17 2004-07-22 Scimed Life Systems, Inc. Unbalanced reinforcement members for medical device
JP2009207533A (ja) * 2008-02-29 2009-09-17 Kaneka Corp 医療用チューブ
JP2012029872A (ja) * 2010-07-30 2012-02-16 Terumo Corp カテーテル

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040143239A1 (en) * 2003-01-17 2004-07-22 Scimed Life Systems, Inc. Unbalanced reinforcement members for medical device
JP2009207533A (ja) * 2008-02-29 2009-09-17 Kaneka Corp 医療用チューブ
JP2012029872A (ja) * 2010-07-30 2012-02-16 Terumo Corp カテーテル

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Publication number Publication date
CN120456949A (zh) 2025-08-08
JPWO2024143282A1 (https=) 2024-07-04
JP7850825B2 (ja) 2026-04-23
KR20250154360A (ko) 2025-10-28

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