WO2023233723A1 - カテーテル - Google Patents

カテーテル Download PDF

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Publication number
WO2023233723A1
WO2023233723A1 PCT/JP2023/005300 JP2023005300W WO2023233723A1 WO 2023233723 A1 WO2023233723 A1 WO 2023233723A1 JP 2023005300 W JP2023005300 W JP 2023005300W WO 2023233723 A1 WO2023233723 A1 WO 2023233723A1
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WO
WIPO (PCT)
Prior art keywords
reinforcing body
shaft
catheter
overlapping
reinforcing
Prior art date
Application number
PCT/JP2023/005300
Other languages
English (en)
French (fr)
Japanese (ja)
Inventor
アロングコット ジッタワット
リエングヴィワット ティアンパワット
Original Assignee
朝日インテック株式会社
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 朝日インテック株式会社 filed Critical 朝日インテック株式会社
Publication of WO2023233723A1 publication Critical patent/WO2023233723A1/ja

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Classifications

    • 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 technology disclosed herein relates to a catheter.
  • a catheter is a long medical device that is inserted into a living body lumen such as a blood vessel and used to diagnose or treat the inside of the living body lumen.
  • the catheter includes a cylindrical shaft and a reinforcing body that reinforces the shaft.
  • As the reinforcing body for example, a coil body spirally wound around the shaft is used (see, for example, Patent Document 1).
  • the shaft may stretch.
  • an object e.g., an embolic coil for plugging an aneurysm or a highly viscous embolus.
  • the resistance between the object and the surface of the lumen may cause the shaft to elongate.
  • the catheter when the catheter is inserted into a bent part or an occluded part in a blood vessel and then pulled back toward the proximal end, the shaft may be stretched.
  • a simple coil body is used as a reinforcement body to reinforce the shaft, so when the shaft tries to stretch, the reinforcement body stretches or misaligns, and the reinforcement body There is a problem in that it is not possible to sufficiently improve the elongation resistance of.
  • This specification discloses a technique that can solve the above-mentioned problems.
  • the catheter disclosed herein includes a cylindrical shaft, a first reinforcing body, and a second reinforcing body.
  • the first reinforcing body is composed of a plurality of wires wound helically around the shaft.
  • the second reinforcing body is composed of at least one strand of wire spirally wound around the shaft so as to overlap the first reinforcing body in the radial direction of the shaft.
  • the first reinforcing body is located radially inward of the shaft from the second reinforcing body. do.
  • the first reinforcing body is located radially outward of the shaft from the second reinforcing body.
  • the first reinforcing body and the second reinforcing body restrain each other. Therefore, according to this catheter, when the shaft tries to stretch, the first reinforcing body and the second reinforcing body restrain each other, thereby preventing stretching or positional shift, and the first reinforcing body
  • the elongation resistance of the shaft can be sufficiently improved by the body and the second reinforcing body.
  • At least some of the overlapping locations may be configured such that the first overlapping locations and the second overlapping locations are regularly arranged along the longitudinal direction of the shaft. If this configuration is adopted, the first reinforcing body and the second reinforcing body firmly restrain each other, so that the elongation resistance of the shaft can be further effectively improved.
  • the overlapping locations may be configured such that the first overlapping locations and the second overlapping locations are alternately arranged along the longitudinal direction of the shaft. If this configuration is adopted, the first reinforcing body and the second reinforcing body restrain each other more firmly, so that the elongation resistance of the shaft can be extremely effectively improved.
  • the number of strands constituting the second reinforcing body may be smaller than the number of strands constituting the first reinforcing body.
  • the winding direction of the second reinforcing body and the winding direction of the first reinforcing body may be opposite to each other.
  • the number of overlapping parts of the first reinforcement body and the second reinforcement body is increased. I can do it. Therefore, if this configuration is adopted, the first reinforcing body and the second reinforcing body restrain each other more firmly, thereby effectively improving the elongation resistance of the shaft.
  • An explanatory diagram schematically showing the side configuration of the catheter 100 of this embodiment An explanatory diagram schematically showing a cross-sectional configuration of a portion of the catheter 100 (X1 section in FIG. 1) An explanatory diagram schematically showing a side configuration of a portion of the catheter 100 (X1 portion in FIG.
  • FIG. 1 is an explanatory view schematically showing a side configuration of a catheter 100 of the present embodiment
  • FIG. 2 is an explanatory view schematically showing a cross-sectional configuration of a portion of the catheter 100 (X1 portion in FIG. 1).
  • FIG. 3 is an explanatory diagram schematically showing a side configuration of a portion of the catheter 100 (portion X1 in FIG. 1).
  • each figure shows XYZ axes that are orthogonal to each other.
  • the Z-axis positive direction side is the distal end side (distal side) inserted into the body
  • the Z-axis negative direction side is the base end side (proximal side) operated by a technician such as a doctor.
  • a part of the structure of the catheter 100 is shown enlarged or omitted as appropriate.
  • each figure shows a state in which the central axis Ax of the catheter 100 is approximately straight parallel to the Z-axis direction, the catheter 100 has flexibility to the extent that it can be curved. .
  • distal end is referred to as the "distal end”
  • distal end and the vicinity thereof is referred to as the “distal end”
  • proximal end is referred to as the "proximal end”
  • proximal end is referred to as the proximal end
  • the catheter 100 is inserted into a living body lumen such as a vascular system, a lymphatic system, a biliary system, a urinary tract system, a respiratory system, a digestive system, a secretory gland, and a reproductive organ, and is used to diagnose or treat the inside of a living body lumen.
  • a living body lumen such as a vascular system, a lymphatic system, a biliary system, a urinary tract system, a respiratory system, a digestive system, a secretory gland, and a reproductive organ.
  • the catheter 100 includes a shaft 10, a distal reinforcement 20, a proximal reinforcement 30, and a connector 90.
  • the shaft 10 is a cylindrical long member that extends along the central axis Ax.
  • the shaft 10 is formed with an inner cavity 10M (FIG. 2) that extends along the central axis Ax from the distal end to the proximal end of the shaft 10.
  • the cross-sectional shape of the inner cavity 10M can take any arbitrary shape, but is approximately circular, for example.
  • the lumen 10M of the shaft 10 is for passing a concomitant device (e.g., a guide wire, a microcatheter, etc.) or a fluid (e.g., an embolic material for occluding an aneurysm, an expansion medium for dilating a balloon catheter, etc.). used for.
  • a concomitant device e.g., a guide wire, a microcatheter, etc.
  • a fluid e.g., an embolic material for occluding an aneurysm, an expansion medium for dilating a
  • the outer diameter, inner diameter, and overall length of the shaft 10 can be set arbitrarily.
  • the outer diameter of the shaft 10 is, for example, about 0.2 mm to 2.0 mm, and the total length of the shaft 10 is, for example, about 1200 to 1800 mm.
  • a first marker 18 and a second marker 19 are provided at the tip of the shaft 10.
  • the first marker 18 is placed near the tip of the shaft 10, and the second marker 19 is placed a predetermined distance (for example, about 30 mm) from the first marker 18 on the proximal side.
  • the first marker 18 and the second marker 19 are made of a radiopaque material.
  • a technician such as a doctor can grasp the position of the tip of the shaft 10 by visually recognizing the first marker 18 under radiation. Further, even if the first marker 18 cannot be visually recognized under radiation, the operator can grasp the position of the tip of the shaft 10 based on the position where the second marker 19 is visually recognized and the predetermined distance.
  • the shaft 10 is composed of an inner layer 11 and an outer layer 12.
  • the inner layer 11 is a cylindrical member that defines the inner cavity 10M
  • the outer layer 12 is a cylindrical member that covers the outer periphery of the inner layer 11. Note that in FIG. 3, illustration of the outer layer 12 is omitted for convenience of explanation.
  • the shaft 10 is preferably formed of a material that is antithrombotic, flexible, and biocompatible.
  • materials for forming the shaft 10 include resin materials such as polyamide resin, polyolefin resin, polyester resin, polyurethane resin, silicone resin, and fluororesin.
  • the inner layer 11 is made of polytetrafluoroethylene (PTFE), and the outer layer 12 is made of nylon-based elastomer resin.
  • the configuration including the material forming the shaft 10 may be uniform over the entire length, or may be different from section to section along the longitudinal direction.
  • the connector 90 constitutes the proximal end of the catheter 100 and is a member held by the operator.
  • the connector 90 includes, for example, a substantially cylindrical main body 91 and a plurality of blades 92 formed on the outer peripheral surface of the main body 91.
  • a proximal end portion of the shaft 10 is inserted and joined to the distal end portion of the main body portion 91 .
  • An opening (not shown) communicating with the inner cavity 10M of the shaft 10 is formed at the base end of the main body portion 91 .
  • the connector 90 is made of a resin material such as polyamide, polypropylene, polycarbonate, polyacetal, polyether sulfone, or the like.
  • the distal end reinforcement body 20 is a member for reinforcing the shaft 10 and is embedded in the distal end portion of the shaft 10. As shown in FIG. 2, the distal end reinforcement body 20 is wrapped around the outer peripheral surface of the inner layer 11 of the shaft 10 and covered by the outer layer 12 of the shaft 10. The configuration of the distal end reinforcement body 20 will be described in detail later.
  • the proximal reinforcing body 30 is a member for reinforcing the shaft 10, and is buried in a portion of the shaft 10 closer to the proximal end than the portion where the distal reinforcing body 20 is buried.
  • the proximal reinforcing body 30 may have any configuration, but for example, it may be a mesh-shaped cylindrical body (a so-called braid) made of wires in a mesh weave, or it may be a mesh-shaped cylindrical body made of wires wound in a spiral shape. It may be a coil body.
  • the proximal reinforcing body 30 is made of, for example, a metal material or a resin material. In FIG. 1, for convenience of explanation, the distal end reinforcing body 20 and the proximal reinforcing body 30 embedded in the shaft 10 are shown by solid lines.
  • the distal end reinforcing body 20 includes a first reinforcing body 21 and a second reinforcing body 22. As shown in FIGS. 2 and 3, the distal end reinforcing body 20 includes a first reinforcing body 21 and a second reinforcing body 22. As shown in FIGS. 2 and 3, the distal end reinforcing body 20 includes a first reinforcing body 21 and a second reinforcing body 22. As shown in FIGS.
  • the first reinforcing body 21 is a coil body composed of a plurality of wires 21a spirally wound around the shaft 10.
  • the first reinforcing body 21 is composed of eight strands 21a.
  • the eight wires 21a constituting the first reinforcing body 21 are arranged so as to be in contact with each other along the longitudinal direction of the shaft 10 (direction parallel to the central axis Ax).
  • the first reinforcing body 21 is configured by loosely winding an assembly of these eight wires 21a in a spiral shape.
  • the first reinforcing body 21 is Z-wound around the shaft 10.
  • the second reinforcing body 22 is a coil body composed of at least one strand 22a spirally wound around the shaft 10 so as to overlap with the first reinforcing body 21 in the radial direction of the shaft 10.
  • the second reinforcing body 22 is composed of one strand 22a. That is, the number of strands 22a constituting the second reinforcing body 22 is smaller than the number of strands 21a constituting the first reinforcing body 21.
  • the second reinforcing body 22 is configured by loosely winding this single wire 22a in a spiral shape.
  • the second reinforcing body 22 is wound around the shaft 10 in an S-wound manner. That is, the winding direction of the second reinforcement body 22 and the winding direction of the first reinforcement body 21 are opposite.
  • the first reinforcing body 21 and the second reinforcing body 22 are formed of, for example, a metal material (stainless steel alloy such as SUS304, NiTi alloy, tungsten, etc.) or a resin material. Note that since the number of strands 22a constituting the second reinforcing body 22 is smaller than the number of strands 21a constituting the first reinforcing body 21, the load is concentrated on the strands 22a constituting the second reinforcing body 22. It is preferable that the tensile strength of the material forming the second reinforcing body 22 is higher than the tensile strength of the material forming the first reinforcing body 21.
  • the first reinforcing body 21 is made of, for example, a NiTi alloy
  • the second reinforcing body 22 is made of, for example, tungsten.
  • both the first reinforcing body 21 and the second reinforcing body 22 are spiral coil bodies, they overlap in the radial direction of the shaft 10 at a plurality of overlapping points OP.
  • the first reinforcing body 21 is located on the radially inner side of the shaft 10 (hereinafter simply referred to as "inner side") than the second reinforcing body 22. ing.
  • the first reinforcing body 21 is located on the radially outer side of the shaft 10 (hereinafter simply referred to as "outer side") than the second reinforcing body 22. ).
  • the first reinforcing body 21 overlaps with the second reinforcing body 22 such that the first reinforcing body 21 overlaps with the second reinforcing body OP1, and the first reinforcing body 21 overlaps with the second reinforcing body 22 so that the first reinforcing body 21 A second overlapping location OP2 where the two overlap so as to be located outside the body 22 coexists.
  • a first overlapping point OP1 and a second overlapping point are arranged along the longitudinal direction of the shaft 10 (direction parallel to the central axis Ax).
  • OP2 are arranged alternately.
  • the first overlapping points OP1 and the second overlapping points OP2 are regularly arranged along the longitudinal direction of the shaft 10.
  • first overlapping points OP1 and second overlapping points OP2 are arranged alternately along the longitudinal direction of the shaft 10.
  • first reinforcing body 21 and the second reinforcing body 22 having such a configuration are formed by, for example, using a braiding machine to form bobbins for the eight strands 21a for the first reinforcing body 21 and the second reinforcing body 21. It can be produced by knitting each strand while relatively moving the bobbin for one strand 22a for the body 22.
  • the catheter 100 of this embodiment includes the cylindrical shaft 10, the first reinforcing body 21, and the second reinforcing body 22.
  • the first reinforcing body 21 is composed of a plurality of wires 21a spirally wound around the shaft 10.
  • the second reinforcing body 22 is composed of at least one strand 22a spirally wound around the shaft 10 so as to overlap with the first reinforcing body 21 in the radial direction of the shaft 10.
  • the first overlapping point OP1 which is a part of the plurality of overlapping points OP between the first reinforcing body 21 and the second reinforcing body 22
  • the first reinforcing body 21 is located on the radially inner side of the shaft 10 than the second reinforcing body 22.
  • the second overlapping point OP2 which is another part of the plurality of overlapping points OP, the first reinforcing body 21 is located radially outward of the shaft 10 from the second reinforcing body 22.
  • FIG. 4 is an explanatory diagram schematically showing the configuration of the first reinforcing body 21 and the second reinforcing body 22 in the catheter 100 of this embodiment.
  • FIG. 5 is an explanatory diagram schematically showing the configuration of the first reinforcing body 21 and the second reinforcing body 22 in the catheter 100X1 of the first comparative example
  • FIG. FIG. 2 is an explanatory diagram schematically showing the configurations of a first reinforcing body 21 and a second reinforcing body 22.
  • FIG. 4 is an explanatory diagram schematically showing the configuration of the first reinforcing body 21 and the second reinforcing body 22 in the catheter 100 of this embodiment.
  • FIG. 5 is an explanatory diagram schematically showing the configuration of the first reinforcing body 21 and the second reinforcing body 22 in the catheter 100X1 of the first comparative example
  • FIG. FIG. 2 is an explanatory diagram schematically showing the configurations of a first reinforcing body 21 and a second reinforcing body 22.
  • the first reinforcing body 21 is not restrained by the second reinforcing body 22.
  • the second reinforcing body 22 is restrained by the tension of the first reinforcing body 21, the restraining force is small. Therefore, when the shaft 10 tries to stretch, the first reinforcing body 21 and the second reinforcing body 22 stretch or become misaligned, and the first reinforcing body 21 and the second reinforcing body 22 cause the shaft 10 to It is not possible to sufficiently improve elongation resistance.
  • the second reinforcement body 22 is not restrained by the first reinforcement body 21.
  • the first reinforcing body 21 is restrained by the tension of the second reinforcing body 22, the restraining force is small. Therefore, when the shaft 10 tries to stretch, the first reinforcing body 21 and the second reinforcing body 22 stretch or become misaligned, and the first reinforcing body 21 and the second reinforcing body 22 cause the shaft 10 to It is not possible to sufficiently improve elongation resistance.
  • the first reinforcing body 21 overlaps the first overlapping portion OP1 located inside the second reinforcing body 22, and the first reinforcing body 21 overlaps the second reinforcing body 22.
  • a second overlapping portion OP2 located outside the reinforcing body 22 is also present. Therefore, the first reinforcing body 21 and the second reinforcing body 22 restrain each other. Therefore, when the shaft 10 tries to stretch, the first reinforcing body 21 and the second reinforcing body 22 are restrained from stretching or misaligning due to mutual restraint, and the first reinforcing body 21 and the second reinforcing body 22 are restrained from stretching or misaligning.
  • the elongation resistance of the shaft 10 can be sufficiently improved by the second reinforcing body 22.
  • the elongation resistance of the shaft 10 can be sufficiently improved by the first reinforcing body 21 and the second reinforcing body 22, so that breakage of the shaft 10 can be suppressed. I can do it. Further, it is possible to prevent the combined device that passes through the inner cavity 10M of the shaft 10 from getting stuck or the smooth flow of fluid in the inner cavity 10M being inhibited due to the extension of the shaft 10. Further, it is possible to suppress changes in the positions of the markers (the first marker 18 and the second marker 19) provided at the distal end of the shaft 10 and the intervals between the plurality of markers due to the stretching of the shaft 10. , it is possible to suppress a decrease in the accuracy of positioning the administration of the object based on the position of the marker.
  • the overlapping points OP are arranged such that the first reinforcing body 21 and the first overlapping point OP1 are located inside the second reinforcing body 22 along the longitudinal direction of the shaft 10. , and a second overlapping portion OP2 where the first reinforcing body 21 is located outside the second reinforcing body 22 are regularly arranged. Therefore, according to the catheter 100 of the present embodiment, the first reinforcing body 21 and the second reinforcing body 22 firmly restrain each other, so that the elongation resistance of the shaft 10 can be further effectively improved.
  • the overlapping points OP are arranged such that the first reinforcing body 21 and the first overlapping point OP1 are located inside the second reinforcing body 22 along the longitudinal direction of the shaft 10. , and a second overlapping location OP2 where the first reinforcing body 21 is located outside the second reinforcing body 22 are alternately arranged. Therefore, according to the catheter 100 of the present embodiment, the first reinforcing body 21 and the second reinforcing body 22 restrain each other more firmly, so that the elongation resistance of the shaft 10 can be extremely effectively improved.
  • the number of strands 22a forming the second reinforcing body 22 is smaller than the number of strands 21a forming the first reinforcing body 21. Therefore, according to the catheter 100 of the present embodiment, the elongation resistance of the shaft 10 can be improved while suppressing a decrease in the flexibility of the shaft 10 due to the presence of the second reinforcing body 22.
  • the number of strands 22a constituting the second reinforcing body 22 is one. Therefore, according to the catheter 100 of this embodiment, the elongation resistance of the shaft 10 can be improved while effectively suppressing a decrease in the flexibility of the shaft 10 due to the presence of the second reinforcing body 22.
  • the winding direction of the second reinforcing body 22 and the winding direction of the first reinforcing body 21 are opposite to each other. Therefore, in the catheter 100 of this embodiment, compared to a configuration in which the winding direction of the second reinforcing body 22 and the winding direction of the first reinforcing body 21 are the same, the first reinforcing body 21 and the second reinforcing body 21 are The number of overlapping points OP can be increased. Therefore, according to the catheter 100 of the present embodiment, the first reinforcing body 21 and the second reinforcing body 22 restrain each other more firmly, so that the elongation resistance of the shaft 10 can be effectively improved.
  • the configuration of the catheter 100 in the above embodiment is merely an example, and can be modified in various ways.
  • the first reinforcing body 21 overlaps with the second reinforcing body 22, and the first reinforcing body 21 overlaps with the second reinforcing body 22.
  • the second overlapping points OP2 located further outside are arranged alternately, the arrangement of the first overlapping points OP1 and the second overlapping points OP2 is not limited to this.
  • M first overlapping points OP1 M is an integer of 1 or more
  • N first overlapping points OP1 N is an integer of 1 or more.
  • the configuration may be such that the two overlapping locations OP2 are alternately arranged. Note that such a configuration can be said to be a configuration in which the first overlapping locations OP1 and the second overlapping locations OP2 are regularly arranged. Alternatively, the first overlapping portion OP1 and the second overlapping portion OP2 may be irregularly arranged along the longitudinal direction of the shaft 10.
  • the first reinforcing body 21 is composed of eight strands 21a, but the number of strands 21a constituting the first reinforcing body 21 can be arbitrarily set as long as it is a plurality of strands. be able to.
  • the second reinforcing body 22 is composed of one strand 22a, but the number of strands 22a constituting the second reinforcing body 22 can be set arbitrarily.
  • the number of strands 22a constituting the second reinforcing body 22 is smaller than the number of strands 21a constituting the first reinforcing body 21, but the number of strands 22a constituting the second reinforcing body 22 is The number of strands may be greater than or equal to the number of strands 21a constituting the first reinforcing body 21.
  • the first reinforcing body 21 is Z-wound around the shaft 10 and the second reinforcing body 22 is S-wound around the shaft 10, but conversely, the first reinforcing body 21 is wound around the shaft 10
  • the second reinforcing body 22 may be wound in a Z manner around the shaft 10.
  • the winding direction of the second reinforcement body 22 and the winding direction of the first reinforcement body 21 are opposite, but the winding direction of the second reinforcement body 22 and the winding direction of the first reinforcement body 21 are opposite to each other. may be in the same direction.
  • the distal reinforcement body 20 is embedded in the distal end of the shaft 10, but the distal reinforcement body 20 may be embedded in the proximal end of the shaft 10, or may be embedded in the distal end of the shaft 10.
  • the shaft 10 may be buried in an intermediate portion excluding the base end portion and the base end portion, or may be buried over the entire length of the shaft 10.
  • the shaft 10 is provided with two markers (the first marker 18 and the second marker 19), but the shaft 10 may be provided with only one marker, or the shaft 10 may be provided with two markers (the first marker 18 and the second marker 19). may not be provided.

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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/JP2023/005300 2022-05-30 2023-02-15 カテーテル WO2023233723A1 (ja)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2022-087483 2022-05-30
JP2022087483A JP2023175171A (ja) 2022-05-30 2022-05-30 カテーテル

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WO2023233723A1 true WO2023233723A1 (ja) 2023-12-07

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JP (1) JP2023175171A (enrdf_load_stackoverflow)
WO (1) WO2023233723A1 (enrdf_load_stackoverflow)

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2006515778A (ja) * 2003-01-17 2006-06-08 ボストン サイエンティフィック リミテッド 医療用装置のためのアンバランスな補強部材

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2006515778A (ja) * 2003-01-17 2006-06-08 ボストン サイエンティフィック リミテッド 医療用装置のためのアンバランスな補強部材

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